ETHIOPIAN ESSENTIAL HEALTH LABORATORY

DIAGNOSTICS LIST

Ethiopian Public Health Institute

January 2024
Addis Ababa, Ethiopia
National Essential Health Laboratory Diagnostics List

First Edition

Ethiopian Public Health Institute

© EPHI, JANUARY 2024, ALL RIGHT RESERVED

Table of Contents

Table of Contents ................................................................................................................... I

List of Tables ...................................................................................................................... III

List of Figures ..................................................................................................................... IV

Foreword.............................................................................................................................. V

Message from the Deputy Director General for Health Laboratory Services ....................... VII

Acknowledgements ............................................................................................................. IX

Executive Summary ............................................................................................................. X

Abbreviations and Acronyms ........................................................................................... XIV

1. Introduction ................................................................................................................... 1

1.1 Background............................................................................................................. 1

1.2 Development and Organization of Health Laboratory Services in Ethiopia .............. 2

1.3 Background Factors Considered .............................................................................. 4

2. Rationale, Objectives and Scope .................................................................................... 7

2.1 Rationale ................................................................................................................. 7

2.2 Objective ................................................................................................................ 7

2.3 Scope of the Document ........................................................................................... 7

3. Principles and Processes for the Development of the NELDL ........................................ 9

3.1 Principles ................................................................................................................ 9

3.2 Processes ................................................................................................................ 9

Prioritization Exercise ......................................................................................................... 11

3.3 Prioritization Criteria ............................................................................................ 11

3.4 Description of Prioritization Criteria ..................................................................... 11

3.5 Prioritization Analysis and Ranking ...................................................................... 12

Essential Laboratory Diagnostic List ................................................................................... 15

3.6 Primary Level of Healthcare.................................................................................. 15

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 3.6.1 List of Laboratory Tests at Health Posts ......................................................... 15

3.6.2 List of Laboratory Tests at Health Centers ..................................................... 16

3.6.3 List of Laboratory Tests at Primary Hospitals ................................................ 20

3.7 Secondary Level of Healthcare .............................................................................. 26

3.7.1 List of Laboratory Tests at General Hospitals ................................................. 26

3.8 Tertiary Level of Care ........................................................................................... 38

3.8.1 List of Laboratory Tests at Comprehensive Specialized Hospitals .................. 38

3.9 Standalone Reference Laboratories ....................................................................... 58

3.9.1 List of Laboratory Tests at Regional Reference Laboratories.......................... 58

3.9.2 List of Laboratory Tests at National Reference Laboratories .......................... 67

3.10 Implementation Strategies ................................................................................. 82

3.10.1 Implementation Arrangements ....................................................................... 82

3.10.2 Monitoring and Evaluation Framework .......................................................... 85

3.11 Revision Requirement of the NELDL ................................................................ 95

4. References ................................................................................................................... 97

Annex 1. Contributors ....................................................................................................... 101

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List of Tables

Table 1: Weights in percent assigned to the selected prioritization criteria ........................... 13

Table 2: Indicator Matrix .................................................................................................... 89

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List of Figures

Figure 1: Important Elements Considered for the Development of the NELDL ..................... 5

Figure 2: Key Phases and Steps Involved in the Development of the NELDL...................... 10

Figure 3: The Results Chain ................................................................................................ 88

Figure 4: Information/ Data Exchange ................................................................................. 95

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Foreword

The National Essential Laboratory Diagnostics List (NELDL) for Ethiopia is a comprehensive
and essential resource that stands as a testament to the Ethiopian Public Health Institute’s
commitment to advance the availability and accessibility of essential laboratory diagnostics in
the country. This document is the result of dedicated efforts from all stakeholders and partners,
and its creation marks a significant milestone in our journey towards improving the provision
of quality healthcare services.

The primary aim of this document is to streamline and optimize diagnostic practices across the
healthcare tier system and landscape of Ethiopia. By identifying a carefully curated list of
essential laboratory diagnostics (ELDL), the institute aspires to standardize laboratory testing
services that need to be offered at the different tiers of the healthcare delivery system, along
with strengthening supporting systems such as specimen referral linkages and transportation
systems to ensure equitable access for all communities to essential diagnostic services. The
preparation of this NELDL underscores the unwavering dedication of the institute to advance
the provision of quality laboratory services in the country, and its successful implementation
is believed to promote the quality of healthcare services and improve patient outcomes.

The development of this document involved a rigorous and collaborative process, with experts
from various professional disciplines and stakeholders contributing their invaluable insights.
Through extensive public health facility assessments, document reviews, thoughtful
deliberations, and evidence-based decision-making, it was possible to develop comprehensive
lists of essential laboratory tests that are relevant to the needs of clinical care and treatment
services provided at the different tiers of the country’s health system.

Implementation of the NELDL will mark a significant turning point in improving the quality
of healthcare services provided across all tiers of the health system. By incorporating and
prioritizing these essential diagnostics into routine practice, we envision quicker and more
accurate diagnoses, leading to improved treatment decisions and monitoring of effectiveness,
and ultimately, better patient outcomes. Additionally, this document has the potential to guide
resource allocation, ensuring that our healthcare infrastructure is optimized to deliver these
vital services effectively and efficiently.

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As we embrace the opportunities presented by the NELDL, we recognize its potential to
revolutionize the scope of laboratory service delivery and contribute to the overall well-being
of our citizens. This document goes beyond a mere list of essential laboratory diagnostics; it
embodies and symbolizes our shared commitment to build healthier Ethiopians. We understand
that the NELDL is a living document requiring regular reviews and updates to remain relevant
in with rapidly changing world of laboratory medicine. As innovations and advancements of
invitro diagnostic technologies continue, the list of essential laboratory diagnostics will also
evolve, adapting to new challenges and emerging needs.

We extend our gratitude to all those who have contributed to the development of this crucial
document and look forward to witnessing its positive impact on the health and well-being of
our people.

Mesay Hailu (Ph.D.)

Director General,
Ethiopian Public Health Institute.

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Message from the Deputy Director General for Health Laboratory Services

It's with great pleasure that I emphasize the importance of implementing NELDL to promote
the availability and accessibility of quality diagnostic testing services in Ethiopia. The NELDL
for Ethiopia is a strategic tool designed to prioritize the introduction and implementation of
essential laboratory diagnostic tests at the different tiers of the healthcare service delivery
system while ensuring equitable access for all in need. The compilation and publication of this
comprehensive NELDL marks a significant milestone in the country’s efforts towards the
development of a resilient, sustainable and responsive national health laboratory system.
Informed by rigorous consultations and expert insights, this document is carefully designed to
align with the national strategy for improving the accessibility and quality of laboratory
diagnostic services through enhancing health facility infrastructure, including equipping with
appropriate diagnostic technologies and analytical system, improving supply chain
management system, strengthening specimen referral system and building the capacity of
human resource at all levels of the country’s healthcare service delivery system.

Along with the recently published Strategic Plan for Health Laboratory System (2023-2027),
this document is believed to promote our collective commitments to fostering collaborations
and partnerships across governmental, non-governmental, and partner institutions towards
achieving the anticipated milestones and ultimate goals well within the plan’s implementation
period. The NELDL helps to ensure that limited resources are directed towards high-impact
testing services for clinical and public health interventions like disease prevention, diagnosis,
care and treatment, and monitoring of health outcomes. At the implementation level, systematic
alignment and integration of strategies and activities is crucial for optimized use of resources
and harmonized advancement of the national laboratory system and is recognized as the best
approach to harnessing the full potential of all our health laboratory programs towards ensuring
equitable access to quality diagnostics for all Ethiopians. The successful implementation of the
NELDL does not only significantly contribute to the improvement of equitable access to
quality healthcare services but also allows for evidence-based decision-making for the
informed formulation of healthcare policies and strategies that would guide the development
and strengthening of responsive systems to address current and emerging health challenges.

I extend my heartfelt gratitude to the tireless efforts of individual experts and organizations
who have contributed to the realization of this essential document. A special commendation is
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due to the National Laboratory Capacity Building Directorate for their leadership and
dedication in spearheading the development of the NELDL document. I would also like to use
this opportunity to express the unwavering commitment of my office to do whatever is in its
power to lead and coordinate all efforts for the seamless implementation of this very important
initiative towards improving the availability and accessibility of quality laboratory diagnostic
services to all Ethiopian citizens at all times.

Saro Abdella (Ph.D.)

Deputy Director General for Health Laboratory Services,

Ethiopian Public Health Institute.

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Acknowledgements

The Ethiopian Public Health Institute would like to express its acknowledgements to all
individuals and organizations that have made immense professional contributions to the
successful development of this National Essential Health Laboratory Diagnostics List.

The institute would also like to express its sincere appreciation and thanks to regional health
bureaus and all stakeholders involved for their generous provision of technical support. Lastly,
special thanks goes to FIND for their technical and financial support at every stage of the
document’s preparation.

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Executive Summary

The NELDL for Ethiopia is a document, which outlines the key essential laboratory tests that
should be available at different tiers of public healthcare facilities and easily accessible to all
healthcare service providers for informed clinical decisions and patient management. The
development of the NELDL is also aimed at facilitating the introduction and implementation
of essential tests to support public health related survey and surveillance activities for early
detection of disease outbreaks and aversion of potential public health emergencies. Prioritizing
essential laboratory diagnostics helps optimize resource allocation, ensuring that limited
resources are directed towards high-impact testing services for clinical and public health
interventions. Furthermore, it facilitates a standardized approach to quality healthcare service
delivery, enhancing consistency and equity in service provision.

The NELDL document also guides policy development, enabling evidence-based decision-
making and fostering alignment with international laboratory quality standards and best
practices. Thus, the document is designed to serve as a roadmap for improving the availability
and accessibility of quality laboratory testing services to all in need through effective planning
and implementation at all levels of the healthcare service delivery system in the country. This
executive summary provides an overview of the NELDL document of its aim, component,
structure, the strategies of its implementation and the expected outcomes.

The aim: The NELDL document aims to prioritize essential laboratory diagnostic tests that
need to be available and routinely performed at different levels of public healthcare facilities
for accurate patient diagnosis, monitoring the effectiveness of care and treatment services and
prognosis of health outcomes. The National List is also aimed at guiding the development of
strategies and operational plans for the promotion of quality diagnostic services through
enhancing health facility infrastructure including, equipping with appropriate diagnostic
technologies, improving supply chain management system, strengthening specimen referral
and transportation system and building the capacity of human resource, among other key
laboratory programs. The NELDL is believed to serve as an invaluable tool for resource
mobilization and evidence-based allocation for the advancement of laboratory diagnostic
services across the nation’s public healthcare facilities.

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Key components and structure: The NELDL covers a comprehensive list of essential
diagnostics, encompassing the areas of disease prevention, diagnosis, and curative care and
treatment. It incorporates findings from public health facility assessments, desk reviews on
testing needs of programs and inputs from various stakeholders, including healthcare
professionals, and experts from relevant fields. The document is structured in a user-friendly
manner; categorizing diagnostics based on laboratory disciplines, healthcare levels, and
targeted populations. Additionally, it provides guidance and recommendations for the
development of implementation strategies, a quality assurance system, and monitoring and
evaluation mechanisms.

The NELDL implementation strategy: The implementation strategies described in this

document were developed based on the findings obtained from public healthcare facility
assessments. Key steps followed in the development of the NELDL implementation strategies
included aligning objectives with desired outcomes, identifying inputs, developing activity and
process work plans, defining outputs, determining expected outcomes and impacts, and setting
measurable indicators. Key elements for implementation, among others, include procuring the
necessary equipment, training laboratory professionals, enhancing the supply chain
management system for reagents and consumable supplies, implementing robust quality
assurance programs, and strengthening specimen referral and transportation system. Regional
health bureaus will support the implementation of the strategies by mobilizing resources and
aligning with regional health priorities. The smooth and effective implementation of the
strategies is believed to help achieve the desired outcomes and impacts.

Expected outcomes: The proper implementation of the NELDL at all levels of the healthcare
service delivery system offers several benefits and potential positive impacts. Some of these
include:

 Improved Disease Detection and Management: The availability of essential laboratory

tests will enable the timely and accurate diagnosis of a wide spectrum of diseases,
including infectious diseases like malaria, tuberculosis, and HIV/AIDS. Early detection
allows for prompt initiation of treatment, reducing morbidity and mortality rates.
 Enhanced Treatment Decisions: Accurate and reliable results from essential diagnostic
tests guide healthcare providers in making informed care and treatment decisions.

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 Tailoring treatment to individual patient profiles results in better health outcomes and
reduces the likelihood of inappropriate or ineffective treatments.
 Enhanced Quality of Care: Access to essential laboratory diagnostics enhances the
quality of patient care by providing clinicians with reliable information to guide their
medical decisions and patient management. This ultimately leads to better patient
outcomes and improved patient satisfaction.
 Reduced Disease Burden: By facilitating early detection and timely initiation of
appropriate treatment, essential diagnostic tests can contribute to lowering the overall
disease burden in Ethiopia. This reduction has a cascading effect on public health,
lessening the strain on healthcare facilities and resources.
 Focused Public Health Interventions: Accurate diagnostic data generated from essential
diagnostic tests provides insights into the epidemiology of diseases such as incidence,
prevalence, distribution, and trends. This information supports targeted public health
interventions, such as vaccination campaigns and disease control programs.
 Strengthened Healthcare System: The implementation of ELDL fosters the
development of a resilient and sustainable health system that features a well-structured
laboratory diagnostic network spanning different levels of the healthcare system, a
functional system for specimen referral linkage and testing services, improved overall
healthcare infrastructure including, standardized instrumentation and technology
management practices, streamlined procurement and supply chain management of
laboratory commodities, and others, all working in synergy to ensure the provision of
quality testing services in support of healthcare, public health research and effective
responses to health emergencies.
 Optimized Resource Allocation: The ELDL implementation strategy considers the
country's resource constraints. By focusing on essential and cost-effective tests,
resources can be allocated more efficiently, maximizing the impact of available
funding.
 Capacity Building and Skill Enhancement: Training laboratory personnel at all levels
does not only improve the accuracy of test results but also enhances the knowledge and
skills of the laboratory workforce. This strengthened expertise contributes to the overall
growth and capacity of the health sector.

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  Data-Driven Decision-Making: Real-time data generated by health laboratories
compressively implementing the ELDL allows for evidence-based decision-making.
Health policymakers can use these data to adjust strategies, allocate resources, and plan
for future healthcare, public health emergency management and health research needs.
 International Collaborations and Recognition: Successful implementation of the ELDL
can promote the healthcare innovations and modern laboratory diagnostics to improve
the health and well-being of its citizens, as well as contribute its share to global health
security. Collaborations and partnerships with global health organizations and partners
can enhance the country's visibility and access to modern laboratory sciences and
technologies.

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Abbreviations and Acronyms

AFB Acid-Fast Bacilli

ALT Alanine Amino-Transferase
APTT Activated Partial Thromboplastin Time
AHP Analytical Hierarchy Process
BF Blood Film
CBC Complete Blood Cell Count
CK-MB Creatine Kinase Muscle-Brain subunits
CSH Comprehensive Specialized Hospital
ELDL Essential Diagnostic List
EFDA Ethiopian Food and Drug Authority
EHSP Ethiopian Health Service Package
EID Early Infant Diagnosis
EPHI Ethiopian Public Health Institute
ESR Erythrocyte Sedimentation Rate
FBS Fasting Blood Sugar
Hgb Hemoglobin
HbA1C Hemoglobin A1C
Hct Hematocrit
HBsAg Hepatitis B Surface Antigen
HCV Hepatitis C Virus
HIV Human Immunodeficiency Virus
INR International Normalized Ratio
IVD In Vitro Diagnostic
LFT Liver Function Tests
MCH Mother and Child Health
MoH Ministry of Health
NELDL National Essential Diagnostic List
NTWG National Technical Working Group
PCV Packed Cell Volume;
PT Prothrombin Time
PTT Partial Thromboplastin Time

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RBS Random Blood Sugar
RFT Renal Function Tests
RPR Rapid Plasma Reagin
SIDM Society to Improve Diagnosis in Medicine
TB Tuberculosis
TSH Thyroid-Stimulating Hormone
UHC Universal Health Coverage
VL Viral Load
WHO World Health Organization

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 1. Introduction

1.1 Background

Laboratory service is an essential component of the Ethiopian health care system that supports
the diagnosis and clinical management of patients, the detection and prevention of epidemic or
pandemic prone diseases and health researches. A capable and responsive health laboratory
system is key for the accurate diagnosis of diseases for treatment planning, monitoring the
effectiveness and prognosis of treatment outcomes, and detection of drug resistance. The
availability and accessibility of quality-assured diagnostics would assist in the optimal use of
the Essential Medicine List (EML). Although Ethiopia has had EML for many years and the
vital role of diagnostics for its effective use was long recognized, a document that provides
details on the list of essential diagnostics for was not developed.

One of the key targets of the Sustainable Development Goal 3 (Good Health and Well-Being)
is achieving Universal Health Coverage (UHC) by 2030 as stated under section 3.8. This
specific target, aims to ensure that all people have access to healthcare services when and where
needed without incurring financial hardship. Thus, to achieve the stated UHC target, it is
critical that everyone is able to access quality and affordable diagnostic laboratory services.
Against this background, the World Health Organization (WHO) initiated the development of
Essential Laboratory Diagnostic List (ELDL) in 2014 to address the critical need for
standardized, prioritized, and cost-effective diagnostic tests. The ELDL was first published in
2018, comprising a curated list of key medical tests required to diagnose and manage common
health conditions at various levels of healthcare settings. It was to serve as guidelines and
recommendations to aid countries in strengthening their diagnostic capacities towards ensuring
universal access to essential diagnostics. Following WHO recommendations, India and Nigeria
were the first countries to develop their National Diagnostics Lists.

Publication of a National Essential Laboratory Diagnostics List (NELDL) is vital for the
promotion and effective use of invitro diagnostics (IVD) for improved quality of healthcare,
advanced health researches and evidence-based management of public health emergences. It
facilitates and catalyzes strategic collaborations and partnerships among stakeholders and
partners working for the advancement of health laboratory capacity and services for the
accurate diagnosis of disease conditions and timely detection of harmful pathogens of public

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health concern. A full-fledged implementation of a NELDL at all levels of the healthcare
system presents immense opportunities to address the multitude of problems impeding
equitable access of citizens to high-quality diagnostic testing services. Knowledge translation
based on data generated by a laboratory system implementing, a NELDL is one of the crucial
inputs to crafting sound policies, strategies, programs, initiatives and implementation
guidelines that aim to improve the health and well-being of populations, provide more effective
health services and quality products, and build a resilient and sustainable health system.

Recently, the African Society for Laboratory Medicine (ASLM) has released a guide intended
to provide countries in Africa with guidance around developing a NELDL or revising their
existing documents to accelerate the implementation and effective use of IVDs. Appreciating
the urgent need to improve the availability of accessible, quality diagnostics in public health
facilities, the Ethiopian Public Health Institute (EPHI) established a Task Force for the
development of a NELDL as an opportunity to improve diagnostic services across the country’s
health system. The initiative was also anticipated to complement the essential list of medicines
for Ethiopia and the interconnected implementation of which is believed to elevate the quality
of healthcare at reasonable and affordable out-of-pocket expenses thus propelling the country’s
efforts towards achieving the Universal Health Coverage of the SDG by 2030.

1.2 Development and Organization of Health Laboratory Services in Ethiopia

In Ethiopia, the early days of formal public health laboratory diagnostic services date back to
the introduction of modern healthcare to the country around the end of the 19th century and the
beginning of the 20th century. As such, it is safe to assume that modest laboratory diagnostic
services were associated with the establishments of the Russian, Harar Ras Mekonen and
Minilik II Hospitals in 1897, 1903 and 1906, respectively. Some evidences also indicate that
personal physicians of Emperor Minilik and the palace’s pharmacists were also using
microscopes for the investigations of certain ailments, but that also happened during the last
ten years of the 19th century. Although the scope of modern clinical laboratory diagnostic
services has continued to grow along with the establishment of more public hospitals prior to,
during and after the Italian fascist occupation, its development took a remarkable turn with the
establishment of the Imperial Medical Research Institute in 1940 which later evolved into
Institute Pasteur d’Ethiopie following the contractual agreement made between the Imperial
Ethiopian Government and the Government of France in 1952. The French team of the Institute

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Pasteur of Paris developed the first well-organized laboratory departments, which included
bacteriology, parasitology, serology/immunology, hematology, clinical and analytical
chemistry. The institute, which was later renamed as Imperial Central Laboratory and Research
Institute at the termination of the contract agreement with the Government of France in 1964,
has played a crucial role in the development of medical laboratory sciences and diagnostics in
the country. It was home to the first school of medical laboratory sciences and technology and
has continued supplying a large number of qualified laboratory professionals to the healthcare
system until the middle of 1990. Starting from its time as Imperial Central Laboratory and
Research Institute, the institute has been spearheading the establishment of Regional Reference
Laboratories, building and strengthening their capacities for the provision of advanced clinical
diagnostic and public health testing services. The institute’s reference laboratories have not
only been serving as the referral and reference testing centers of the nation but also as the
backbone of the national health laboratory system by contributing to the development of
national strategies, programs, initiatives and implementation approaches for building the
capacities of diagnostic laboratories at different tiers of the healthcare system. Throughout
their existence, the EPHI’s National Reference Laboratories have been responsible for the
evaluation and validation of new methods and technologies, the definition of testing algorithms
for effective results for patient management, standardization and the harmonization of
diagnostic services offered at different levels of the laboratory system. In this regard, the
publication of this NELDL is just one piece of EPHI’s multi-faceted undertaking to ensure the
availability and accessibility of quality laboratory diagnostic services to all Ethiopians.

The Ethiopian health laboratory system closely follows the country's healthcare delivery
system, including hospitals, health centers, and health posts. The standalone Regional
Reference Laboratories provide advanced referral diagnostic testing services to all public and
private healthcare facilities, starting from the lowest to the highest based on their geographic
proximities and pre-defined referral networks. The Ethiopian Laboratory System is comprised
of four-tiered decentralized networks of laboratories arranged in a triangular manner with the
National Reference Laboratories at EPHI being the top position (Level IV) and those associated
with health centers occupying the broader base (Level I). Regional Reference Laboratories and
laboratories associated with Specialized University Hospitals including, those of referral
hospitals of the Uniformed Forces (Federal Army, Federal Police and Federal Prison
Administration) and the National Blood Bank Laboratory Center are categorized under Level

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III. All other hospital laboratories are grouped into Level II. As expected and in line with the
needs of clinical care services provided at the healthcare facilities with which the laboratories
are associated, the scope of the test menu and complexity of testing increase from the lowest
level at health centers to the highest level at the National Reference Laboratories. As a
mechanism to widen access, an integrated specimen referral linkage and transportation system
has been designed and implemented to facilitate specimen referral from any lower tier to the
next and beyond for advanced testing services. This organizational arrangement of the national
health laboratory system and functional supporting systems have been instrumental for
implementation and management of diverse laboratory programs including, the expansion of
access to available diagnostic services. Although commendable progress could be made over
the past years in building the capacity of the national health laboratory system to effectively
support healthcare service delivery and public health emergency management systems
including basic and operational health researches. There are still many outstanding challenges
that need to be addressed for the system to become more responsive to the needs of its users.
Inadequate infrastructure including instrumentations across all tiers, an inconsistent and
unreliable supply chain of laboratory commodities, an inefficient system for the provision of
equipment maintenance services and lack of clear standards on the scope of tests that are
expected to be performed at each level of the laboratory and healthcare systems are among the
key challenges currently confronting the laboratory system. It is believed that this NELDL
document will serve as an invaluable tool in guiding the development of appropriate strategies
and operational action plans to address most of the aforementioned challenges in a
standardized, integrated and harmonized manner.

1.3 Background Factors Considered

Inconsistent availability and accessibility, or a total lack of essential health laboratory tests,
especially in public health facilities in Ethiopia challenges the health system and remains one
of the prominent bottlenecks for achieving the strategic goal of the UHC. To bridge this
problem, the WHO, starting from 2018 is recommending and encouraging member countries
to establish and implement a National Essential Diagnostic List. The EPHI, as the technical
arm of the Ministry of Health (MoH) and the national responsible authority for building the
capacity of the health laboratory system, has therefore taken the lead to develop the NELDL.
To this end, the institute has established a National Technical Working Group (NTWG)
comprising of laboratory experts from key stakeholders and partners. To design the NELDL,
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the NTWG has led and coordinated the collection and analysis of data on the following relevant
elements: health tier system, health policy, funding (availability and affordability of laboratory
tests), epidemiological data (communicable & non communicable diseases), different
guidelines, availability of the required infrastructure and human resources (Figure 1).

Figure 1: Important Elements Considered for the Development of the NELDL

The collaborative efforts extended to international guidelines, with inputs from the WHO
generic EDL, the recently published ASLMs' EDL guidelines, and benchmarks from other
countries, such as India's EDL. These collective documents facilitated and helped the
systematic identification of laboratory tests associated with national vertical programs and
those pertinent to epidemic or pandemic prone diseases. Throughout the process, critical factors
like the disease burden, spanning diseases under vertical disease programs, and the necessary
tests for effective management of public health emergencies were thoughtfully considered.

A comprehensive assessment of public health facilities was also conducted to ascertain current
trends in laboratory service delivery. This assessment involved 203 healthcare facilities
belonging to different tiers and utilized a structured questionnaire, which had been adapted and
modified from WHO documents. The questionnaire assesses the most significant test types and
their availability within the healthcare facility tier system. Challenges in providing laboratory
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services within public health facilities were identified, including issues related to poor
laboratory quality management system, supply shortages, and limited test accessibility.
Notably, disparities in test types and pricing among different healthcare facilities were also
observed.

The findings of this assessment informed the inclusion of specific criteria for prioritization,
such as the top ten diseases, clinicians' test requirements, the test availability index, cost-
effectiveness analysis, and the profile of laboratory personnel. These considerations were
crucial for the development of the NELDL, aimed at enhancing the accessibility and quality of
essential diagnostic tests within the healthcare system.

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 2. Rationale, Objectives and Scope

2.1 Rationale

The rationale behind the preparation of NELDL is to develop an essential IVDs list for
Ethiopia. The list will guide the standardization of diagnostic services at different levels of the
healthcare service delivery system. It also aims at ensuring equitable access to crucial
laboratory diagnostics services, enhancing the quality of healthcare services, and guiding the
effective utilization and integration of the essential IVDs within the national healthcare system
to foster better diagnostic practices across the entire levels.

The list also helps to reduce over diagnosis and over treatment, by identifying unnecessary or
redundant diagnostic tests and excluding them from the ELDL. It saves resources and prevents
potential harm to patients. It can guide the development of laboratory infrastructure, workforce
training, and procurement strategies. Furthermore, it supports the provision of efficient,
patient-centered care and treatment services allowing timely diagnosis, fast clinical decisions
and prompt interventions.

2.2 Objective

The objective of developing NELDL is to establish a prioritized essential IVDs across different
levels of the healthcare service delivery system. It will provide baseline information for
agencies and nongovernmental organizations that support the selection, procurement, supply,
donation, or provision of IVDs in Ethiopia. Furthermore, it will inform in vitro diagnostics
producing manufacturers about the diagnostic priorities of the country and the IVDs promoted
as part of the comprehensive implementation of the NELDL at scale. The overarching objective
is to contribute to Ethiopia’s multi-faceted efforts to attain the UHC thorough guaranteeing its
citizens full access to all essential health services at an affordable overall cost.

2.3 Scope of the Document

The scope of the NELDL is to provide a list of essential IVDs required for the diagnosis and
monitoring of various diseases in Ethiopia. This list includes IVDs for communicable and non-
communicable diseases that should be available at different levels of the country’s health
system. It also provides comprehensive information on requirements that need to be met to
ensure the availability and accessibility of quality diagnostic services, such as infrastructure
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including, equipment, a reliable system for supply chain management of other laboratory
commodities, a quality assurance system, human and financial resources, and regulatory and
licensing aspects of diagnostics. The list can be used by the MoH and its public health agencies
and stakeholders for planning purposes and resource mobilization. Ultimately, it improves the
capacity of the health system to achieve accurate diagnosis, save health resources, and improve
patient outcomes.

Besides, the document defines several features of IVDs, including the purpose of the test, assay
formats and specimen types per current international standards and practices, and relevant
health care settings appropriate for the investigations of non-communicable and communicable
endemic and epidemic-prone diseases.

This document on IVDs focuses on the diagnosis of a wide array of disease conditions in
clinical chemistry, hematology, immunology, microbiology and other medical laboratory
disciplines, and also discusses specialized testing services such as blood transfusions and
targeted tests for surveillance activities. The NELDL enlists 14 diagnostic test categories; 7
differential IVDs to aid the diagnosis of a range of disease conditions, and 7 disease-specific
IVDs in clinical settings of the health system, including national and regional reference
laboratories, hospitals, health centers and health posts.

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 3. Principles and Processes for the Development of the NELDL

3.1 Principles

The values that governed the development of the NELDL were an unwavering commitment to
ensuring universal and equitable access for all in need to quality and affordable diagnostic
services, meeting diagnostic service needs anywhere at all times, and promoting diagnostic
capacity at all levels of the healthcare tier system.

This NELDL document was developed by reviewing and utilizing a variety of references,
including the Ethiopian Standard Agency IVDs requirements for all levels of healthcare
facilities, the WHO guidelines, national health policy and strategy documents, the status and
practices of diagnostic laboratory service provision at selected public health facilities, relevant
national guidelines, and comments from various stakeholders and partners. Moreover,
additional inputs have been obtained from the clinicians, nurses, Health Management
Information System experts, laboratory professionals, pharmacy professionals, medical
directors, and CEOs of the health facilities.

3.2 Processes

This NELDL was developed with the intention of ensuring the availability and accessibility of
laboratory diagnostics for the provision of quality laboratory testing services and contributing
to Ethiopia’s efforts towards achieving the UHC by guaranteeing its citizens full access to all
essential health services at an affordable overall cost. A NTWG comprising experts
representing key stakeholders, partner organizations, academic institutions and professional
associations was formed with clear terms of reference to develop this document.

The whole process in developing NELDL was based on a review of relevant national guiding
documents, analysis of the available epidemiological data and findings from the current
laboratory service delivery assessment. In-depth analysis of data and generation of evidences
was conducted to define prioritization criteria, then ranking tests based on the criteria and
finally establishing the NELDL. The step-by-step preparation phase is detailed in the below
figure (Figure 2).

9|Page
Figure 2: Key Phases and Steps Involved in the Development of the NELDL

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Prioritization Exercise

3.3 Prioritization Criteria

An in-depth review of national health policy, strategic plans, essential health services package,
pertinent guidelines and other vital documents related to the healthcare system and services in
the country was conducted. And also an assessment was made across selected healthcare
facilities in order to establish an evidence-based and logically prioritized list of necessary
diagnostic tests. The goal was to rank the tests according to how important they are to patient
care. The results of the review process and assessment findings showed a significant difference
in the scope of laboratory services provided by the selected public healthcare facilities. This
and other findings were crucial inputs in defining the prioritization criteria. The NELDL has
been established using several criteria, including disease burden, test availability, leading
causes of morbidity, reagents and supplies’ availability, urgency of tests, cost-effectiveness,
tests related to vertical disease prevention and control programs, clinician test preferences,
infrastructure capacity, and personnel educational profile/qualification.

The NELDL document was developed for all levels of healthcare facilities, encompassing
primary, secondary and tertiary healthcare levels, and standalone national and regional
reference laboratories to standardize and prioritize essential diagnostic tests across the
healthcare system. The test disciplines incorporated in the NELDL for primary and secondary
level health facilities include general testing areas such as clinical chemistry, hematology,
serology/immunology, bacteriology, mycology, urinalysis, and parasitology, alongside
disease-specific tests for conditions like tuberculosis, Human immunodeficiency virus (HIV),
and COVID-19. Tertiary healthcare, National and Regional Reference Laboratories
incorporate additional test disciplines such as molecular and other advanced laboratory testing,
building upon the disciplines listed for primary and secondary level facilities.

3.4 Description of Prioritization Criteria

Disease Burden: It is the overall effect of a particular disease on a population, taking into
account both mortality and morbidity rates that includes factors like prevalence, incidence,
disability-adjusted life years (DALYs), and years of potential life lost (YPLL). Prioritizing an
essential diagnostic list based on the disease burden of the country ensures that the most
significant health problems and sufferings of the population are addressed.
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Test Availability Index (AI): the AI refers to the laboratory test availability and accessibility
to the target population in the given catchment through the public health facility.
Urgency of the test: Health facilities that provide health care services that necessitate the
availability of urgently needed tests in the event of emergency case management.
Top Ten Diseases: Health facilities regularly identify the top ten diseases based on their
contribution to mortality and morbidity. Prioritizing testing for these priority diseases helps
direct resources to areas of greatest need, enabling interventions that can significantly improve
health outcomes.
Clinicians' Test Needs: It is the demand and necessity of the test as perceived by the clinicians.
Addressing the demand and necessity of the clinicians is crucial for effective and improved
quality of health care service, which in turn improves patient outcomes.
Tests for Vertical Disease Programs: The prevention, diagnosis, and treatment of particular
diseases established to be of high burden and public health relevance are the focus of vertical
disease programs. Diseases with existing national programs include HIV, Tuberculosis,
Malaria, neglected tropical diseases, cervical cancer, etc. The laboratory tests for maternal and
child healthcare services (MCH) was also considered. Prioritizing laboratory tests for the
diagnosis and treatment monitoring of vertical disease programs allows for a focused approach
to combat specific diseases effectively and tackle complex health challenges systematically.
Cost Effectiveness: Cost effectiveness is selected as a prioritization criterion in order to
maximize the health benefit from the available resources. It entails assessing the tests that offer
significant health gains at a reasonable cost, enabling effective resource allocation.
Availability of the required infrastructure: Refers to the availability and readiness of the
needed infrastructure and facilities to safely, efficiently and successfully perform a given
laboratory test.
Reagents and supplies’ availability status: Supply chain management aims to ensure the
efficient movement of supplies and reagents throughout the chain from the manufacturer to the
end user level, which impacts the feasibility of test availability and accessibility.

Laboratory personnel level of education: The level of education is the knowledge, skills and
competencies needed to impart the quality of work the intended test requires.

3.5 Prioritization Analysis and Ranking

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Prioritization of the available, ambitious list of laboratory tests, which is categorized in each
tier system, is a complex process that involves considering multiple criteria for decision
making. All the selected and established criteria have substantial values for test prioritization
and finally contribute to having a short list of essential laboratory diagnostic tests. A careful
prioritization of tests for public health facilities categorized by each tier system, can ensure that
laboratory testing services are primarily targeted towards areas with high disease burden, most
significant and realistic health problems of the population (Table 1).

Taking the objectives of the document and the nature of the established criteria into
consideration, the tests are prioritized based on the Analytical Hierarchy Process (AHP)
method. The AHP is a decision-making method that uses pairwise comparisons to assess the
comparative importance of a criterion and assign a specific weight through the judgment of
experts to derive priority scales. It is commonly used to make decisions systematically and in
a structured way by assigning appropriate weights to all established criteria based on their
relative importance to the scope of the document.

Table 1: Weights in percent assigned to the selected prioritization criteria

SN Established Prioritization Criteria Weight by expert decision

1 Disease burden 15%

2 Test availability index (TAI) 12%

3 Urgency of the test 12%

4 Top ten diseases 12%

5 Clinicians’ test need 10%

6 Tests for vertical disease programs 10%

7 Cost-effectiveness/price of the test/budget impact 8%

8 Availability of the Required Infrastructure 8%

9 Personnel educational profile/qualification 7%

10 Reagents and supplies’ availability status 6%

Prioritization criteria of the test presented in number or count or percentage was scored from 1
to 5. The range is decided and divided into five intervals of equal width based on the highest

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number or count or percentage ‘n’ of each specific criterion and the lowest number or count or
percentage is 1.

For those criteria, which either have no data in numerical forms or are not feasible to quantify
like tests for vertical disease programs, urgency of the test, reagents and supplies’ availability
status, and personnel educational profile/qualification are evaluated on the bases of ‘YES’ or
‘NO’ options. The laboratory tests available or required for the listed criteria are labeled ‘YES’
and then provided a score of 5 whereas a test that does not meet the requirement is labeled
‘NO’ and assign a score 1.

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Essential Laboratory Diagnostic List

3.6 Primary Level of Healthcare

Ethiopia has implemented a three-tier healthcare service delivery system. One of the levels is the primary level of healthcare, which comprises a
primary hospital, health center, and its satellite health posts. The arrangement of essential diagnostic tests for these health facilities differ as there
are differences in the scope of clinical care services provided at each of the facilities, availability of budgetary resources and, existing infrastructure,
among others.

3.6.1 List of Laboratory Tests at Health Posts

SN Test IV Diagnostic test Test purpose Specimen type Assay format Equipment used
category/Disease
1 Clinical Chemistry Glucose To diagnose and screen for Capillary Whole RDT /Glucometer Glucometer
diabetes Blood
2 Hematology Hemoglobin To diagnose and monitor Capillary Whole Haemoglobinometer Haemoglobinometer
anemia Blood (POC)
3 Parasitology Malaria To identify malaria parasites Capillary Whole RDT /Cassette NA
Blood
4 Serology/Immunology Qualitative HIV To detect HIV antibodies Capillary Whole Cassette/Device NA
Antibody Test Blood, plasma, oral
fluid
5 Serology/Immunology Syphilis For the diagnosis or as an aid in Capillary Whole RDT /Cassette/Device NA
(TPHA/RPR/VDRL) the diagnosis of T. pallidum Blood
6 Serology/Immunology Pregnancy Test To assess the status of Urine RDT/ Cassette/Device NA
pregnancy
7 Urinalysis Urinalysis/dipstick To detect urinary tract Urine Multi-parameter strips Strip based
infections, glucose, blood, etc. /Dipstick

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3.6.2 List of Laboratory Tests at Health Centers

SN Test Category IV Diagnostic test Test purpose Specimen type Assay format Equipment
/Disease used
1 Bacteriology & Gram staining As a critical test for rapid and All (pus, discharge Microscopic examination of Microscope
Mycology presumptive diagnosis of sputum) except urine, slides as wet preparations or
infectious agents directly stool and blood treated with organism-
from specimens specific chemical stains (e.g.
Gram stain)
2 Bacteriology & Molecular WRD test Diagnosis of TB and Rif Sputum/Body fluid Nucleic Acid Amplification Authomated/
Mycology resistance Test ( semi-
automated
3 Bacteriology & LF-LAM For the diagnosis of active Urine RDT for the detection of Point of Care
Mycology TB in people living with lipoarabinomannan (LAM) Test (RDT)
HIV/AIDS levels in the urine for
PLWHIV
4 Bacteriology & Cryptococcal antigen For screening and diagnosis Capillary whole blood Cryptococcal antibody-coated N/A
Mycology of cryptococcal meningitis at Venous whole blood, latex particles agglutinate
ART sites with specimens containing
cryptococcal antigen (CrAg)
5 Bacteriology & Indian ink As a critical test for rapid and CSF, sputum and Cryptococcus yeast cell Microscope
Mycology presumptive diagnosis of bronchoalveolar lavage surrounded by a characteristic
infective agents directly from fluid polysaccharide capsule –
specimens Visualized microscopically,
India Ink stains the
background, revealing the
extra cellular capsule
6 Bacteriology & KOH For presumptive diagnostic of Skin, scalp, nail scrap KOH Microscope
Mycology infective agents directly from
specimen
7 Bacteriology & ZN/FM Diagnosis/Treatment Sputum/Body fluids Microscope Microscope
Mycology monitoring TB

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 SN Test Category IV Diagnostic test Test purpose Specimen type Assay format Equipment
/Disease used
8 Clinical Chemistry Glucose To screen and monitor for Serum/Plasma Photometer Semi-
diabetes and intermediate automated
hyperglycemia, to diagnose
hypoglycemia
9 Clinical Chemistry Urea To assess kidney function Serum/Plasma Photometer Semi-
automated
10 Clinical Chemistry Creatinine To monitor kidney function Serum/Plasma Photometer Semi-
for management of severe automated
infections
11 Clinical Chemistry GOT/AST To assess liver function Serum/Plasma Photometer Semi-
automated
12 Clinical Chemistry GPT/ALT To assess liver function Serum/Plasma Photometer Semi-
automated
13 Clinical Chemistry ALP To aid in the diagnosis of Serum Photometer Semi-
hepatobiliary diseases and automated
bone disorders
14 Clinical Chemistry Uric Acid To diagnose and monitor gout Serum/Plasma Photometer Semi-
automated
15 HIV Qualitative HIV For the diagnosis of HIV Capillary whole Nucleic Acid Amplification mWRD
virological nucleic infection in infants < 18 blood/Venous whole Test (HIV/EID)
acid test (Early Infant months of age blood/Dried blood spots
Diagnosis for HIV
(EID) )
16 Immuno-Hematology COMPLETE To evaluate overall health and Capillary blood EDTA Automated hematology CBC analyzer
BLOOD COUNT to detect a wide range of venous blood analyzer
(CBC) disorders, including anemia,
infections, leukemias, red
blood cell, white blood cell
and platelet abnormalities and
primary immune disorders

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 SN Test Category IV Diagnostic test Test purpose Specimen type Assay format Equipment
/Disease used
17 Immuno-Hematology CD4 and CD8% For staging advanced HIV Capillary whole blood Point-of care Point of care
disease and monitoring Venous whole blood
response to antiretroviral
therapy. (In settings where
viral load is not available)
18 Immuno-Hematology Blood Group and Rh To determine A, B and O Capillary or EDTA Slide agglutination test NA
groups and Rh type venous blood
19 Immuno-Hematology Erythrocyte It is used as indication of Capillary or EDTA Sedimentation of red blood Plastic
sedimentation rate presence of disease venous blood cells Citrated ESR
Graduated
Pipette Tube
20 Parasitology Direct microscopy for Microscopy of fresh faeces Stool/faeces Wet smear Microscope
ova or parasite for detection of trophozoites,
ova, cysts & larvae of the
parasite
21 Parasitology Peripheral smear for For the diagnosis of one or Capillary/Venus blood Blood Staining Microscope
malaria and other more human malaria species
parasite detection (P. falciparum, P. vivax, P.
malariae, P. ovale) and
Borrela spps
22 Parasitology Skin snip For the detection of Skin snip Wet smear Microscope
microfilariae of O. volvulus
23 Parasitology Wet mount For the detection of T. Urine Vaginal discharges Wet smear Microscope
vaginalis
24 Serology/Immunology Pregnancy test To aid in the early detection Urine (early Rapid diagnostic test (RDT) NA
of pregnancy morning)/Serum/Plasma
25 Serology/Immunology Pallidum-Haem- For the diagnosis or as an aid Capillary or Venous Agglutination/ RDT/ cassette NA
Agglutination in the diagnosis of T. whole blood
(TPHA) Rapid Test pallidum
Cassette

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 SN Test Category IV Diagnostic test Test purpose Specimen type Assay format Equipment
/Disease used

26 Serology/Immunology Hepatitis B surface To screen for acute and Capillary or Venous Rapid diagnostic test (RDT)/ NA
antigen (HBsAg) chronic HBV infection whole blood cassette
27 Serology/Immunology Hepatitis C (Anti- To screen for HCV infection: Oral fluid, Capillary Rapid diagnostic test (RDT)/ NA
HCV antibody) whole blood or whole cassette
blood
28 Serology/Immunology H. pylori Ag/Ab To identify current infection Stool, serum Rapid diagnostic test (RDT/ NA
cassette
29 Serology/Immunology Papilloma virus For cervical cancer screening Cervical cells collected in RDT/ test cassette NA
test specific transport
fluid
30 Serology/Immunology Proteus Weil Felix Detects typhus and specific Serum RDT/ test cassette NA
Test- OX19 rickettsial infections
31 Serology/Immunology Salmonella (Widal To detect the presence of Serum RDT/ test cassette NA
Test (H, O)) typhoid and paratyphoid fever
32 Serology/Immunology rk39 (leishmania) To aid in the diagnosis of Serum Capillary Venous Rapid diagnostic test NA
clinically suspected visceral whole blood2 (RDT)chromatography
leishmaniasis
33 Serology/Immunology Qualitative HIV To diagnose HIV Infection Oral fluid, Capillary, Rapid diagnostic test (RDT) NA
Antibody Test serum or whole blood
34 Urinalysis Urinalysis/dipstick To detect urinary tract Urine Multi- parameter strip N/A
infections, glucose and others (dipstick)
35 Urinalysis Urine Microscopic Microscopic urine sediment Urine Microscopy Microscope
examination for detection of
S. haematobium, cells and
infectious agents

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 3.6.3 List of Laboratory Tests at Primary Hospitals

SN Test Category IV Diagnostic test Test purpose Specimen type Assay format Equipment
/Disease used
1 Bacteriology & Gram staining As a critical test for rapid and All except urine, Microscopic examination of slides Microscope
Mycology presumptive diagnosis of stool and blood as wet preparations or treated with
infective agents directly from organism-specific chemical stains
specimens (e.g., Gram stain)
2 Bacteriology & Vibrio Cholerae For initial detection or exclusion Stool, rectal RDT NA
Mycology antigen test of cholera outbreak (not for use swab
in case management
3 Bacteriology & Wet mount For the detection of T.Vaginalis, Genital Discharge mixed with physiologic Microscope
Mycology Candiasis discharge, saline, examine using low- and
lesions, high-power magnifications. for BV
and a yeast infection
4 Bacteriology & Indian ink As a critical test for rapid and CSF, sputum and Cryptococcus yeast cell Microscope
Mycology presumptive diagnosis of bronchoalveolar surrounded by a characteristic
infective agents directly from lavage fluid polysaccharide capsule –
specimens Visualized microscopically, India
Ink stains the background,
revealing the extra cellular capsule

5 Bacteriology & KOH For presumptive diagnostic of Skin, scalp, nail Microscopic examination of slides Microscope
Mycology infective agents directly from scrap
specimen
6 Clinical Chemistry Glucose To diagnose and screen for Serum/Plasma Optical /Semi- Semi-automated/
diabetes and intermediate automated/Automated Methods Automated
hyperglycemia Analyzer

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SN Test Category IV Diagnostic test Test purpose Specimen type Assay format Equipment
/Disease used
7 Clinical Chemistry Urea To assess kidney function Serum/Plasma Optical /Semi- Semi-automated/
automated/Automated Methods Automated
Analyzer
8 Clinical Chemistry Creatinine To monitor kidney function for Serum/Plasma Optical /Semi- Semi-automated
management of severe infections automated/Automated Methods /Automated
Analyzer
9 Clinical Chemistry GOT/AST To assess liver function Serum/Plasma Optical /Semi- Semi-automated/
automated/Automated Methods Automated
Analyzer
10 Clinical Chemistry GPT/ALT To assess liver function Serum/Plasma Optical /Semi- Semi-automated/
automated/Automated Methods Automated
Analyzer
11 Clinical Chemistry ALP To aid in the diagnosis of Serum/plasma Optical /Semi- Semi-automated/
hepatobiliary diseases and bone automated/Automated Methods Automated
disorder Analyzer
12 Clinical Chemistry Total and Direct To detect or monitor liver Serum/Plasma Optical /Semi- Semi-automated/
Bilirubin disease, bile duct disorders and automated/Automated Methods Automated
hemolytic anemia and to Analyzer
differentiate between these
causes of jaundice
13 Clinical Chemistry Total Protein To diagnose nutritional Serum/Plasma Optical /Semi- Semi-automated/
problems, kidney and liver automated/Automated Methods Automated
diseases. Analyzer
14 Clinical Chemistry Albumin To detect or monitor Serum/Plasma Optical /Semi- Semi -automated/
malnutrition, kidney, liver automated/Automated Methods Automated
diseases or mal-absorption Analyzer

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SN Test Category IV Diagnostic test Test purpose Specimen type Assay format Equipment
/Disease used
15 Clinical Chemistry GGT To assess hepatobiliary function Serum/Plasma Optical /Semi- Semi-automated
automated/Automated Methods /Automated
Analyzer

16 Clinical Chemistry Uric Acid To diagnose and monitor gout Serum/Plasma Optical /Semi- Semi-automated
automated/Automated Methods /Automated
Analyzer
17 HIV Qualitative HIV For diagnosis of HIV infection in Capillary whole Nucleic Acid Amplification Test Molecular WRD
virological nucleic infants < 18 months of age blood/Venous test
acid test (Early whole
Infant Diagnosis for blood/Dried blood
HIV (EID) ) spots
18 Immuno-Hematology COMPLETE To evaluate overall health and to Capillary blood Automated hematology analyzer CBC analyzer
BLOOD COUNT detect a wide range of disorders, EDTA venous
(CBC) including anemia, infections, blood
leukemia, RBC, WBC and
platelet abnormalities and
primary immune disorders
19 Immuno-Hematology Blood Group and Rh To determine A, B and O groups Capillary blood Slide agglutination test NA
and Rh type EDTA venous
blood
20 Immuno-Hematology Blood cross To determine blood compatibility Venous whole Slide and/or tube agglutination NA
matching for blood transfusions blood Capillary test
blood, Serum
21 Immuno-Hematology Direct Coombs test To aid in the diagnosis of the Venous whole Red blood cell agglutination NA
cause of immune hemolytic blood
anemia

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SN Test Category IV Diagnostic test Test purpose Specimen type Assay format Equipment
/Disease used
22 Immuno-Hematology Indirect Coombs test To screen for antibodies to red Serum Red blood cell agglutination NA
blood cells before a blood
transfusion or in pregnancy, To
aid in the diagnosis of hemolytic
anemia and blood transfusion
reaction
23 Immuno-Hematology Erythrocyte it is used as indication for the Capillary or Sedimentation of red blood Disposable
sedimentation rate presence of inflammatory and EDTA venous Plastic Citrated
infectious diseases blood ESR Graduated
Pipette Tube
24 Immuno-Hematology Morphology For the detection of RBC, WBC Capillary whole Manual Microscope
examination and platelet abnormalities, blood Venous
(Peripheral blood) malignancies and parasites and whole blood
for white blood cell differential
count
25 Immuno-Hematology CD4% & CD8% For staging advanced HIV Capillary whole Point of care POC
disease and monitoring response blood Venous
to ART. (In settings where viral whole blood
load is not available)
26 Parasitology Direct microscopy Microscopic examiation of fresh Stool/faeces Wet smear Microscope
and/or formol-ether faeces for detection of
concentration test trophozoites, ova, cysts, larvae
and adult worm of the parasite
27 Parasitology Peripheral smear for For the diagnosis of one or more Capillary/venous Blood Staining Microscope
malaria parasite human malaria species blood
detection (P. falciparum, P. vivax, P.
malariae, P. ovale) and Borrela
spps
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SN Test Category IV Diagnostic test Test purpose Specimen type Assay format Equipment
/Disease used
28 Parasitology Wet mount For the detection of T. vaginalis Urine Wet smear Microscope
29 Parasitology Skin snip For the detection of microfilariae Skin snip Wet smear Microscope
of O. volvulus
30 Parasitology Stained aspirates and For investigation of cutaneous or Bone marrow, microscopy Microscope
smears visceral leishmania lymph, spleen,
liver, tissue
aspirate
31 Serology HIV rapid test To diagnose HIV Infection Oral fluid, Rapid diagnostic test (RDT)/ NA
Capillary or Cassette
whole blood
32 Serology/Immunology Pregnancy test To aid in the early detection of Urine (early Rapid diagnostic test (RDT) NA
pregnancy morning) (dipstick and cassette), latex
agglutination /test strip
33 Serology/Immunology Hepatitis B surface To screen for acute and chronic Capillary or Rapid diagnostic test (RDT)/ Test NA
antigen (HBsAg) HBV infection Venous whole Cassette
blood
34 Serology/Immunology Hepatitis C (Anti- To screen for HCV infection: Oral fluid, Rapid diagnostic test (RDT)/ Test NA
HCV antibody) Capillary blood or Cassette
whole blood
35 Serology/Immunology Syphilis For the diagnosis or as an aid in Capillary or Rapid diagnostic test (RDT)/ Test NA
(TPHA/RPR/VDRL) the diagnosis of T. pallidum Venous whole Cassette
blood
36 Serology/Immunology Human Papilloma For cervical cancer Cervical cells Rapid diagnostic test (RDT)/ Test NA
Virus collected in test Cassette
specific transport
fluid

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SN Test Category IV Diagnostic test Test purpose Specimen type Assay format Equipment
/Disease used
37 Serology/Immunology H. pylori Ag/Ab To identify current infections Stool Rapid diagnostic test (RDT/ Test NA
Cassette
38 Serology/Immunology RF (Rheumatoid To diagnose rheumatoid arthritis Serum rapid latex agglutination test NA
Factor) (RA)
39 Serology/Immunology Salmonella (Widal To detect the presence of with Serum RDT/ Test Cassette NA
Test (H, O)) typhoid and paratyphoid fever.
40 Serology/Immunology ASO (anti- To diagnose a strep infection Serum rapid latex agglutination test NA
streptolysin O)
41 Serology/Immunology Cryptococcal Detection of cryptococcal Serum and Rapid chromatography/lateral NA
antigen test capsular polysaccharide antigen cerebrospinal flow/ Test Cassette
(CrAg) fluid
42 Serology/Immunology Proteus Weil Felix Detects typhus and specific Serum RDT/ Test Cassette NA
Test- OX19 rickettsial infections
43 TB ZN/FM Diagnosis/Treatment monitoring Sputum/Body Microscopic examination of Microscope
fluids stained slides
44 TB mWRD Diagnosis Sputum/Body Nucleic Acid Amplification Test mWRD
fluids
45 TB LF-LAM For the diagnosis of TB at ART Urine RDT for the detection of NA
sites lipoarabinomannan (LAM) levels
in the urine
46 Urinalysis Urinalysis/dipstick To detect urinary tract infections Urine Multi- parameter Strip (dipstick) NA
47 Urinalysis Urine Microscopic Microscopic Urine sediment Urine Microscope Microscope
examination for detection of S.
haematobium, cells and
infectious agents

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 3.7 Secondary Level of Healthcare

The secondary level of healthcare comprises general hospitals. General hospitals are organized to provide health care services for referral cases
from the primary level in addition to the patients visiting the facility. The arrangement of essential diagnostic tests for these health facilities differ
from the primary level laboratories as they are expected to provide broader and advanced diagnostic tests in line with the increased scope of clinical
care services, have relatively better infrastructure and budgetary resources.

3.7.1 List of Laboratory Tests at General Hospitals

SN Test Category/ IV Diagnostic test Test purpose Specimen type Assay format Equipment
Disease used
1 Bacteriology & Wet mount Microscopic examination of Genital discharge, Discharge mixed with physiologic Microscope
Mycology vaginal discharge or lesions, saline, examine using low- and
scrapings from vulvar lesions high-power magnifications. for BV
and a yeast infection
2 Bacteriology & Culture and Initial step in detection and Disease-appropriate Culture on growth media plates or Traditional
Mycology Antimicrobial identification of bacterial and specimens (e.g., broth in an incubator followed by manual
susceptibility testing fungal species for selection of blood, urine, stool, recovery of isolates and species techniques and
(AST) appropriate antibiotic cerebrospinal fluid, identification (traditional manual Automated
regimens etc.) techniques or automated
equipment)
3 Bacteriology & Gram staining As a critical test for rapid and All except urine, Microscopic examination of slides Microscope
Mycology presumptive diagnosis of stool and blood as wet preparations or treated with
infective agents directly from organism-specific chemical stains
specimens (e.g., Gram stain)

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SN Test Category/ IV Diagnostic test Test purpose Specimen type Assay format Equipment
Disease used
4 Bacteriology & Indian ink As a critical test for rapid and CSF, sputum and Cryptococcus yeast cell Microscope
Mycology presumptive diagnosis of bronchoalveolar surrounded by a characteristic
infective agents directly from lavage fluid polysaccharide capsule Visualized
specimens microscopically, India Ink stains
the background, revealing the extra
cellular capsule
5 Bacteriology & Vibrio Cholerae For initial detection or Stool, rectal swab RDT NA
Mycology antigen test exclusion of cholera outbreak
(not for use in case
management
6 Bacteriology & KOH For presumptive diagnostic of Skin, scalp, nail Microscopic examination of slides Microscope
Mycology infective agents directly from scrap
specimen
7 Bacteriology & ZN/FM Diagnosis/Treatment Sputum/Body fluids Staining of sputum/body fluid Microscope
Mycology monitoring
8 Bacteriology & Molecular WRD test For the diagnosis of active Sputum/Body fluids Nucleic Acid Amplification Test mWRD
Mycology TB
9 Bacteriology & LF-LAM For the diagnosis of active Urine RDT for the detection of NA
Mycology TB in ART sites lipoarabinomannan (LAM) levels
in the urine
10 Clinical Chemistry Direct and total To detect or monitor liver Serum/Plasma Automated Methods for basic Automated
Bilirubin disease, bile duct disorders chemistry parameters, Analyzer
and hemolytic anemia and to Immunoassay for hormonal tests,
differentiate between these Blood gases analyzer for blood
causes of jaundice gases

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SN Test Category/ IV Diagnostic test Test purpose Specimen type Assay format Equipment
Disease used
11 Clinical Chemistry GOT/AST To assess liver function Serum/Plasma Optical /Semi- Semi-
automated/Automated Methods for automated/
basic chemistry parameters, Automated
Immunoassay for hormonal tests,
Analyzer
Blood gases analyzer for blood
gases
12 Clinical Chemistry GPT/ALT To assess liver function Serum/Plasma Optical /Semi- Semi-
automated/Automated Methods for automated/
basic chemistry parameters, Automated
Immunoassay for hormonal tests,
Analyzer
Blood gases analyzer for blood
gases
13 Clinical Chemistry ALP To aid in the diagnosis of Serum/Plasma Optical /Semi- Semi-
hepatobiliary diseases and automated/Automated Methods for automated/
bone disorders basic chemistry parameters, Automated
Immunoassay for hormonal tests,
Analyzer
Blood gases analyzer for blood
gases
14 Clinical Chemistry Glucose To diagnose and screen for Serum/Plasma Optical /Semi- Semi-
diabetes and intermediate automated/Automated Methods for automated/
hyperglycemia, to diagnose basic chemistry parameters, Automated
Immunoassay for hormonal tests,
hypoglycemia Analyzer
Blood gases analyzer for blood
gases
15 Clinical Chemistry Creatinine To monitor kidney function Serum/Plasma Optical /Semi- Semi-
for management of severe automated/Automated Methods for automated/
infections basic chemistry parameters, Automated
Immunoassay for hormonal tests,
Analyzer
Blood gases analyzer for blood
gases

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SN Test Category/ IV Diagnostic test Test purpose Specimen type Assay format Equipment
Disease used
16 Clinical Chemistry Electrolytes (Na, K, To detect an acid-base Serum/Plasma ISE Semi-
Cl, phosphate) imbalance in blood automated/
Automated
Analyzer
17 Clinical Chemistry Urea To assess kidney function Serum/Plasma Optical /Semi- Semi-
automated/Automated Methods for automated/
basic chemistry parameters, Automated
Immunoassay for hormonal tests, Analyzer
Blood gases analyzer for blood
gases
18 Clinical Chemistry Cholesterol To assess risk of Serum/Plasma Optical /Semi- Semi-
cardiovascular disease (CVD) automated/Automated Methods for automated/
basic chemistry parameters, Automated
Immunoassay for hormonal tests, Analyzer
Blood gases analyzer for blood
gases
19 Clinical Chemistry Triglyceride To assess risk of Serum/Plasma Optical /Semi- Semi-
cardiovascular disease (CVD) automated/Automated Methods for automated/
basic chemistry parameters, Automated
Immunoassay for hormonal tests, Analyzer
Blood gases analyzer for blood
gases
20 Clinical Chemistry Urine chemistry To detect and quantify Urine Optical /Semi- Semi-
(Creatinine, TP, substances in the urine automated/Automated Methods for automated/
albumin, UA, Ca, associated with metabolic basic chemistry parameters, Automated
glucose, Na, Cl, K, disorders, renal dysfunction Immunoassay for hormonal tests, Analyzer
Phosphate) or urinary tract infections. Blood gases analyzer for blood
gases

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SN Test Category/ IV Diagnostic test Test purpose Specimen type Assay format Equipment
Disease used
21 Clinical Chemistry Uric Acid To diagnose and monitor gout Serum/Plasma Optical /Semi- Semi-
automated/Automated Methods for automated/
basic chemistry parameters, Automated
Immunoassay for hormonal tests, Analyzer
Blood gases analyzer for blood
gases
22 Clinical Chemistry GGT To assess hepatobiliary Serum/Plasma Optical /Semi- Semi-
function, To distinguish automated/Automated Methods for automated/
between bone and basic chemistry parameters, Automated
hepatobiliary causes of raised Immunoassay for hormonal tests, Analyzer
ALP Blood gases analyzer for blood
gases
23 Clinical Chemistry LDL To assess risk of Serum/Plasma Optical /Semi- Semi-
cardiovascular disease (CVD) automated/Automated Methods for automated/
basic chemistry parameters, Automated
Immunoassay for hormonal tests, Analyzer
Blood gases analyzer for blood
gases
24 Clinical Chemistry HDL To assess risk of Serum/Plasma Optical /Semi- Semi-
cardiovascular disease (CVD) automated/Automated Methods for automated/
basic chemistry parameters, Automated
Immunoassay for hormonal tests, Analyzer
Blood gases analyzer for blood
gases
25 Clinical Chemistry LDH To assess metabolic acidosis, Serum/Plasma Optical /Semi- Semi-
diabetic keto-acidosis, sepsis automated/Automated Methods for automated/
and dehydration basic chemistry parameters, Automated
Immunoassay for hormonal tests, Analyzer
Blood gases analyzer for blood
gases

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SN Test Category/ IV Diagnostic test Test purpose Specimen type Assay format Equipment
Disease used
26 Clinical Chemistry CRP To detect inflammation as an Serum/Plasma Optical /Semi- Semi-
indicator of various automated/Automated Methods for automated/
conditions (e.g., basic chemistry parameters, Automated
cardiovascular disease (CVD) Immunoassay for hormonal tests, Analyzer
high sensitivity CRP required, Blood gases analyzer for blood
sepsis) gases
27 Clinical Chemistry Albumin To detect or monitor Serum/Plasma Optical /Semi- Semi-
malnutrition, kidney, liver automated/Automated Methods for automated/
disease or malabsorption basic chemistry parameters, Automated
Immunoassay for hormonal tests, Analyzer
Blood gases analyzer for blood
gases
28 Clinical Chemistry Progesterone Utilized in fertility diagnosis Serum/Plasma Optical /Semi- Semi-
for the detection of ovulation automated/Automated Methods for automated/
and assessment of the luteal basic chemistry parameters, Automated
phase Immunoassay for hormonal tests, Analyzer
Blood gases analyzer for blood
gases
29 Clinical Chemistry FSH Used to indicate congenital Serum/Plasma Automated Methods for basic Semi-
diseases with chromosome chemistry parameters, automated/
aberrations, polycystic Immunoassay for hormonal tests, Automated
ovaries (PCO), amenorrhea Blood gases analyzer for blood Analyzer
(causes), and menopausal gases
syndrome
30 Clinical Chemistry TSH To screen for hypothyroidism Serum/Plasma Optical /Semi- Semi-
and hyperthyroidism automated/Automated Methods for automated/
basic chemistry parameters, Automated
Immunoassay for hormonal tests, Analyzer

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SN Test Category/ IV Diagnostic test Test purpose Specimen type Assay format Equipment
Disease used
31 Clinical Chemistry LH Used to indicate congenital Serum/Plasma Optical /Semi- Semi-
diseases with chromosome automated/Automated Methods for automated/
aberrations, polycystic basic chemistry parameters, Automated
ovaries (PCO), amenorrhea Immunoassay for hormonal tests Analyzer
(causes), and menopausal
syndrome
32 Clinical Chemistry Total Protein To diagnose nutritional Serum/Plasma Optical /Semi- Semi-
problems, kidney disease and automated/Automated Methods for automated/
liver disease. basic chemistry parameters Automated
Analyzer
33 Clinical Chemistry Troponin To diagnose myocardial Serum/Plasma Optical /Semi- Semi-
infarction automated/Automated Methods for automated/
basic chemistry parameters, Automated
Immunoassay for hormonal tests Analyzer
34 Clinical Chemistry T3/FT3 To screen for hypothyroidism Serum/Plasma Optical /Semi- Semi-
and hyperthyroidism automated/Automated Methods for automated/
basic chemistry parameters, Automated
Immunoassay for hormonal tests Analyzer
35 Clinical Chemistry T4/FT4 To screen for hypothyroidism Serum/Plasma Optical /Semi- Semi-
and hyperthyroidism automated/Automated Methods for automated/
basic chemistry parameters, Automated
Immunoassay for hormonal tests Analyzer

36 Clinical Chemistry CK-MB To determine the myocardial Serum/Plasma Optical /Semi- Semi-
infraction automated/Automated Methods for automated/
basic chemistry parameters Automated
Analyzer
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SN Test Category/ IV Diagnostic test Test purpose Specimen type Assay format Equipment
Disease used
37 Clinical Chemistry Hb A1C To diagnose and monitor Venous whole blood Optical /Semi- Semi-
treatment of diabetes mellitus automated/Automated Methods for automated/
basic chemistry parameters, Automated
Immunoassay for hormonal tests, Analyzer
Blood gases analyzer for blood
gases
38 HIV Qualitative HIV For the diagnosis of HIV Capillary whole Nucleic Acid Amplification Test mWRD
virological nucleic infection in infants < 18 blood/Venous whole
acid test (Early Infant months of age blood/Dried blood
Diagnosis for HIV spots
(EID) )
39 Human Papilloma Virus Human Papilloma Used for cervical cancer Serum/plasma Rapid chromatography NA
Virus screening
40 Immuno-Hematology Complete Blood To diagnose and monitor Capillary or venous Automated hematology analyzer, CBC Analyzer
Count (CBC) anemia and blood. total and differential counts of (Five diff)
polycythemia, To monitor white blood cell (WBC), Red
the safety of certain drugs, blood cell (RBC), platelets.
Clinical marker for certain
severe infections (e.g.,
malaria, viral hemorrhagic
fevers), Aid in the diagnosis
of intravascular hemolysis,
renal conditions,
rhabdomyolysis
(myoglobinuria)
41 Immuno-Hematology Blood Group and Rh To determine A, B and O Capillary blood Slide agglutination test NA
groups and Rh type

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SN Test Category/ IV Diagnostic test Test purpose Specimen type Assay format Equipment
Disease used
42 Immuno-Hematology Erythrocyte To detect the presence of citrate whole blood Semi-automated analyzer. Disposable
sedimentation rate inflammation caused by one Plastic
or more conditions such as Citrated ESR
infections, tumors or Graduated
autoimmune diseases Pipette Tube
43 Immuno-Hematology Blood cross matching To determine blood Capillary and Slide and/or tube agglutination test NA
compatibility for blood Venous whole blood
transfusions
44 Immuno-Hematology Prothrombin time and To detect or diagnose a Citrate plasma Hand-held or automated Coagulation
international bleeding disorder or coagulation analyzer analyzer
normalized ratio thrombotic disorder
(PT/INR) (prothrombin time (PT),
Monitor performance of
anticoagulant medications
(International normalized
ratio (INR))
45 Immuno-Hematology CD4%, CD8% For staging advanced HIV Venous whole blood Flowcytometry CD4 analyzer
disease.

46 Immuno-Hematology LYMPHOCYTE For monitoring response to Venous whole blood Flowcytometry CD4 analyzer
IMMUNE- Antiretroviral therapy. (In
PHENOTYPING settings where viral load is
(CD4%, CD4#, not available)
CD3%, CD3#, CD8#,
CD8%, CD4/CD8
RATIO & CD45#)

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SN Test Category/ IV Diagnostic test Test purpose Specimen type Assay format Equipment
Disease used

47 Immuno-Hematology Morphology For detection of red blood Capillary and venous Romanowsky stained blood films Microscope
examination cell, white blood cell and whole blood
(peripheral blood, platelet abnormalities,
bone marrow, Biopsy, malignancies and parasites
….) and for white blood cell
differential count
48 Parasitology Wet mount For the detection of T. Urine Wet smear Microscope
vaginalis
49 Parasitology Peripheral smear for For the diagnosis of one or Capillary/venous Blood Staining (Thick and thin Microscope
malaria and other more human malaria species blood films)
parasite detection (P. falciparum, P. vivax, P.
malariae, P. ovale), Borrela
spps, For detection of
trypomastigotes stage of T.b.
50 Parasitology Direct microscopy Microscopy of fresh faeces Stool/faeces Wet smear Microscope
and formol-ether for detection of trophozoites,
concentration of ova, cysts & larvae of the
faeces for ova or parasite
parasite
51 Parasitology Stained aspirates and For investigation of Bone marrow, Aspirate staining Microscope
smears cutaneous or visceral lymph, spleen, liver,
leishmania tissue aspirate
52 Parasitology Skin snip For detection of microfilariae Skin snip Wet smear Microscopy
of O. volvulus
53 Serology/Immunology Hepatitis B surface Screening for acute and Whole blood/serum Rapid diagnostic test NA
antigen (HBsAg) chronic hepatitis B (HBV) (RDT)/cassette
infection: infants over 12
months of age, children,
adolescents, adults

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SN Test Category/ IV Diagnostic test Test purpose Specimen type Assay format Equipment
Disease used
54 Serology/Immunology Hepatitis C (Anti- Screening for HCV infection: Whole blood/serum Rapid diagnostic test NA
HCV antibody) infants over 18 months of (RDT)/cassette
age, children, adolescents,
adults
55 Serology/Immunology Pregnancy test Pregnancy Urine Rapid chromatography/strips NA

56 Serology/Immunology HIV rapid test For the diagnosis of HIV Whole blood/serum Rapid chromatography NA
infection: adults, adolescents,
children and infants over 18
months of age
57 Serology/Immunology Syphilis (TPHA/ For the diagnosis or as an aid Serum/plasma Rapid chromatography/ Cassette NA
RPR/VDRL) in the diagnosis of T.
palladium
58 Serology/Immunology H. pylori Ag/Ab To identify current infection Stool, serum Rapid chromatography/Cassette NA

59 Serology/Immunology ASO (Anti- To help determine whether Serum Rapid chromatography NA

Streptolysin O) you have had a recent strep
infection with the bacteria
group A Streptococcus; To
help diagnose complications
resulting from a strep
infection such as rheumatic
fever or glomerulonephritis, a
form of kidney disease
60 Serology/Immunology Cryptococcal For screening and CSF, Serum Rapid chromatography/ NA
antigen test diagnosis of cryptococcal Cassette
meningitis in people living
with advanced HIV disease
61 Serology/Immunology Salmonella (Widal Diagnosis of typhoid fever Serum/plasma Rapid chromatography/ NA
Test (H, O)) Cassette

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SN Test Category/ IV Diagnostic test Test purpose Specimen type Assay format Equipment
Disease used
62 Serology/Immunology Proteus Weil Felix Diagnosis of typhus fever Serum/plasma Rapid chromatography/ Cassette NA
Test- OX19
63 Serology/Immunology Occult blood Occult blood in the stool may Stool Rapid chromatography NA
indicate colon cancer or
polyps in the colon or rectum
— though not all cancers or
polyps’ bleed.
64 Serology/Immunology Rheumatoid Factor RF test is most often used to Serum/plasma Rapid chromatography NA
(RF) help diagnose rheumatoid
arthritis
65 Serology/Immunology rk39 (leishmania) Diagnosis of visceral Serum Rapid chromatography NA
leishmaniasis (VL)
66 Serology/Immunology Cancer rapid test For the diagnosis of prostate Whole blood/serum Rapid chromatography NA
(PSA) cancer
67 Urinalysis Urinalysis/dipstick To detect urinary tract Urine Multi- parameter Strip (dipstick NA
infections
68 Urinalysis Urine Microscopic Microscopic Urine sediment Urine Microscopy Microscope
examination for detection of
S. haematobium, cells and
infectious agents

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 3.8 Tertiary Level of Care

The tertiary level of healthcare comprises comprehensive specialized hospitals. The comprehensive specialized hospitals are organized to provide
more advanced, comprehensive and specialized healthcare services for all types of referral cases from all levels. The arrangement of essential
diagnostic tests for these health facilities differ from the primary and secondary level laboratories as they are expected to provide wider and
advanced diagnostic tests to meet the needs of specialized and complex healthcare services, have by far better and more advanced infrastructure,
significantly higher budgetary resource and staffed with highly qualified personnel.

3.8.1 List of Laboratory Tests at Comprehensive Specialized Hospitals

SN Test IV Diagnostic test Test purpose Specimen type Assay format Equipment
Category/Disease used
1 Bacteriology & Culture and For the detection of bacterial All clinical specimen Culture Automated /
Mycology Antimicrobial and fungal pathogens Manual
susceptibility testing
(AST)
2 Bacteriology & Wet mount Microscopic examination of Genital discharge, Discharge mixed with Microscope
Mycology vaginal discharge or scrapings lesions, physiologic saline, examine
from vulvar lesions using low- and high-power
magnifications. for BV and
a yeast infection
3 Bacteriology & Gram staining As a critical test for rapid and All except urine, stool Microscopic examination of Microscope
Mycology presumptive diagnosis of and blood slides as wet preparations or
infective agents directly from treated with organism-
specimens specific chemical stains
(e.g., Gram stain)
4 Bacteriology & Vibrio Cholerae For initial detection or exclusion Stool, rectal swab RDT NA
Mycology antigen test of cholera outbreak (not for use
in case management)

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SN Test Category/ IV Diagnostic test Test purpose Specimen type Assay format Equipment
Disease used
5 Bacteriology & Cryptococcal antigen For screening and diagnosis of Capillary whole blood Cryptococcal antibody- NA
Mycology cryptococcal meningitis Venous whole blood, coated latex particles
CSF agglutinate with specimens
containing cryptococcal
antigen (CrAg)
6 Bacteriology & Indian ink As a critical test for rapid and CSF, sputum and Cryptococcus yeast cell Microscope
Mycology presumptive diagnosis of bronchoalveolar surrounded by a
infective agents directly from lavage fluid characteristic polysaccharide
specimens capsule – Visualized
microscopically, India Ink
stains the background,
revealing the extra cellular
capsule
7 Bacteriology & KOH For presumptive diagnostic of Skin, scalp, nail scrap Microscopic examination of Microscope
Mycology infective agents directly from slides
specimen
8 Bacteriology & Molecular WRD test Diagnosis Sputum/Body fluid Nucleic Acid Amplification mWRD
Mycology Test (Xpert MTB/RIF
Assay)

9 Bacteriology & LF-LAM RDT for the detection of LAM Urine RDT for the detection of NA
Mycology (lipoarabinomannan) levels in urine for the diagnosis LAM levels in the urine
of active TB in PLWHIV
10 Bacteriology & ZN/FM Diagnosis/Treatment monitoring Sputum/Body fluid Microscopic examination of Microscope
Mycology stained slides

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SN Test Category/ IV Diagnostic test Test purpose Specimen type Assay format Equipment
Disease used
11 Clinical Chemistry Urea To assess kidney function Serum/Plasma Optical Automated Methods Automated
for basic chemistry Analyzer
parameters, Immunoassay
for hormones and tumor
markers, Blood gas
analyzers for blood gases
12 Clinical Chemistry Urine chemistry To detect and quantify Urine Optical /Semi- Automated
(Creatinine, TP, substances in the urine automated/Automated Analyzer
albumin, UA, Ca, associated with metabolic Methods for basic chemistry
glucose, Na, Cl, K, disorders, renal dysfunction or parameters, Immunoassay
Phosphate) urinary tract infections for hormonal and tumour
markers, Blood gases
analyzer for blood gases
13 Clinical Chemistry GOT/AST To assess liver function Serum/Plasma Optical /Semi- Automated
automated/Automated Analyzer
Methods for basic chemistry
parameters, Immunoassay
for hormonal and tumour
markers, Blood gases
analyzer for blood gases

14 Clinical Chemistry GPT/ALT To assess liver function Serum/Plasma Optical /Semi- Automated
automated/Automated Analyzer
Methods for basic chemistry
parameters, Immunoassay
for hormonal and tumour
markers, Blood gases
analyzer for blood gases

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SN Test Category/ IV Diagnostic test Test purpose Specimen type Assay format Equipment
Disease used
15 Clinical Chemistry ALP To aid in diagnosis of Serum/Plasma Optical /Semi- Automated
hepatobiliary diseases and bone automated/Automated Analyzer
disorders Methods for basic chemistry
parameters, Immunoassay
for hormonal and tumour
markers, Blood gases
analyzer for blood gases
16 Clinical Chemistry Direct and total To detect or monitor liver Serum/Plasma Optical /Semi- Automated
Bilirubin disease, bile duct disorders and automated/Automated Analyzer
hemolytic anemia, To Methods for basic chemistry
differentiate between these parameters, Immunoassay
causes of jaundice for hormonal and tumour
markers, Blood gases
analyzer for blood gases
17 Clinical Chemistry Creatinine To monitor kidney function for Serum/Plasma Optical /Semi- Automated
management of severe infections automated/Automated Analyzer
Methods for basic chemistry
parameters, Immunoassay
for hormonal and tumour
markers, Blood gases
analyzer for blood gases
18 Clinical Chemistry Glucose To diagnose and screen for Serum/Plasma/CSF Optical /Semi- Automated
diabetes and intermediate automated/Automated Analyzer
hyperglycemia, to diagnose Methods for basic chemistry
hypoglycemia parameters, Immunoassay
for hormonal and tumour
markers, Blood gases
analyzer for blood gases

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SN Test Category/ IV Diagnostic test Test purpose Specimen type Assay format Equipment
Disease used
19 Clinical Chemistry Potassium To monitor fluid, electrolyte and Serum/Plasma Optical /Semi- Automated
acid-base balance. automated/Automated Analyzer
Methods for basic chemistry
parameters, Immunoassay
for hormonal and tumour
markers, Blood gases
analyzer for blood gases
20 Clinical Chemistry Chloride To monitor fluid, electrolyte and Serum/Plasma Optical /Semi- Automated
acid-base balance. automated/Automated Analyzer
Methods for basic chemistry
parameters, Immunoassay
for hormonal and tumour
markers, Blood gases
analyzer for blood gases
21 Clinical Chemistry Magnesium Diagnosing and monitoring Serum/Plasma Optical /Semi- Automated
hypomagnesemia and automated/Automated Analyzer
hypermagnesemia Methods for basic chemistry
parameters, Immunoassay
for hormonal and tumour
markers, Blood gases
analyzer for blood gases
22 Clinical Chemistry Calcium Control parathyroid hormone Serum/Plasma Optical /Semi- Automated
(PTH), calcitonin, and vitamin D automated/Automated Analyzer
Methods for basic chemistry
parameters, Immunoassay
for hormonal and tumour
markers, Blood gases
analyzer for blood gases

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SN Test Category/ IV Diagnostic test Test purpose Specimen type Assay format Equipment
Disease used
23 Clinical Chemistry Phosphate To monitor chronic kidney Serum/Plasma Optical /Semi- Automated
disease. To prevent and manage automated/Automated Analyzer
tumor lysis syndrome Methods for basic chemistry
parameters, Immunoassay
for hormonal and tumour
markers, Blood gases
analyzer for blood gases
24 Clinical Chemistry GGT To assess hepatobiliary function, Serum/Plasma Optical /Semi- Automated
To distinguish between bone and automated/Automated Analyzer
hepatobiliary causes of raised Methods for basic chemistry
ALP parameters, Immunoassay
for hormonal and tumour
markers, Blood gases
analyzer for blood gases

25 Clinical Chemistry Total Protein To diagnose nutritional Serum/Plasma/CSF Optical /Semi- Automated
problems, kidney disease and automated/Automated Analyzer
liver disease. Methods for basic chemistry
parameters, Immunoassay
for hormonal and tumour
markers, Blood gases
analyzer for blood gases
26 Clinical Chemistry Albumin To detect or monitor Serum/Plasma Optical /Semi- Automated
malnutrition, kidney, liver automated/Automated Analyzer
disease or malabsorption Methods for basic chemistry
parameters, Immunoassay
for hormonal and tumour
markers, Blood gases
analyzer for blood gases

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SN Test Category/ IV Diagnostic test Test purpose Specimen type Assay format Equipment
Disease used
27 Clinical Chemistry Sodium To monitor fluid, electrolyte and Serum/Plasma Optical /Semi- Automated
acid-base balance. automated/Automated Analyzer
Methods for basic chemistry
parameters, Immunoassay
for hormonal and tumour
markers, Blood gases
analyzer for blood gases
28 Clinical Chemistry Uric Acid To diagnose and monitor gout Serum/Plasma Optical /Semi- Automated
automated/Automated Analyzer
Methods for basic chemistry
parameters, Immunoassay
for hormonal and tumour
markers, Blood gases
analyzer for blood gases
29 Clinical Chemistry CRP To detect inflammation as an Serum/Plasma Optical /Semi- Automated
indicator of various conditions automated/Automated Analyzer
Methods for basic chemistry
parameters, Immunoassay
for hormonal and tumour
markers, Blood gases
analyzer for blood gases
30 Clinical Chemistry Troponin To diagnose myocardial Serum/Plasma Optical /Semi- Automated
infarction automated/Automated Analyzer
Methods for basic chemistry
parameters, Immunoassay
for hormonal and tumour
markers, Blood gases
analyzer for blood gases

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SN Test Category/ IV Diagnostic test Test purpose Specimen type Assay format Equipment
Disease used
31 Clinical Chemistry Cholesterol To assess risk of cardiovascular Serum/Plasma Optical /Semi- Automated
disease (CVD) automated/Automated Analyzer
Methods for basic chemistry
parameters, Immunoassay
for hormonal and tumour
markers, Blood gases
analyzer for blood gases

32 Clinical Chemistry FSH Used to indicate congenital Serum/Plasma Optical /Semi- Automated
diseases with chromosome automated/Automated Analyzer
aberrations, polycystic ovaries Methods for basic chemistry
(PCO), amenorrhea (causes), parameters, Immunoassay
and menopausal syndrome for hormonal and tumour
markers, Blood gases
analyzer for blood gases

33 Clinical Chemistry LH Used to indicate congenital Serum/Plasma Optical /Semi- Automated

diseases with chromosome automated/Automated Analyzer
aberrations, polycystic ovaries Methods for basic chemistry
(PCO), amenorrhea (causes), parameters, Immunoassay
and menopausal syndrome for hormonal and tumour
markers, Blood gases
analyzer for blood gases

34 Clinical Chemistry Estradiol Utilized clinically in the Serum/Plasma Optical /Semi- Automated
elucidation of fertility disorders automated/Automated Analyzer
in the Methods for basic chemistry
hypothalamus-pituitary-gonad parameters, Immunoassay
axis, gynecomastia, for hormonal and tumour
oestrogen-producing ovarian and markers, Blood gases
testicular tumors. analyzer for blood gases

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SN Test Category/ IV Diagnostic test Test purpose Specimen type Assay format Equipment
Disease used
35 Clinical Chemistry Cortisol Used in the regulation of many Serum/plasma/ urine Optical /Semi- Automated
essential physiological automated/Automated Analyzer
processes, including energy Methods for basic chemistry
metabolism, maintenance of parameters, Immunoassay
electrolyte balance and blood for hormonal and tumour
pressure, immunomodulation markers, Blood gases
and stress responses, cell analyzer for blood gases
proliferation
36 Clinical Chemistry β- HCG Aid in early detection and Serum/Plasma Optical /Semi- Automated
monitoring of pregnancy, automated/Automated Analyzer
oncology (to serve the Methods for basic chemistry
management of patients with parameters, Immunoassay
trophoblastic diseases). for hormonal and tumour
markers, Blood gases
analyzer for blood gases
37 Clinical Chemistry Prolactin Utilized in postpartum to Serum/Plasma Optical /Semi- Automated
lactation, affects glucose and automated/Automated Analyzer
lipid metabolism Methods for basic chemistry
parameters, Immunoassay
for hormonal and tumour
markers, Blood gases
analyzer for blood gases
38 Clinical Chemistry T3/FT3 To screen for hypothyroidism Serum/Plasma Optical /Semi- Automated
and hyperthyroidism automated/Automated Analyzer
Methods for basic chemistry
parameters, Immunoassay
for hormonal and tumour
markers, Blood gases
analyzer for blood gases

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SN Test Category/ IV Diagnostic test Test purpose Specimen type Assay format Equipment
Disease used
39 Clinical Chemistry T4/FT4 To screen for hypothyroidism Serum/Plasma Optical /Semi- Automated
and hyperthyroidism automated/Automated Analyzer
Methods for basic chemistry
parameters, Immunoassay
for hormonal and tumour
markers, Blood gases
analyzer for blood gases
40 Clinical Chemistry LDH To assess metabolic acidosis, Serum/Plasma Optical /Semi- Automated
diabetic keto-acidosis, sepsis automated/Automated Analyzer
and dehydration Methods for basic chemistry
parameters, Immunoassay
for hormonal and tumour
markers, Blood gases
analyzer for blood gases
41 Clinical Chemistry Testosterone To monitor male secondary sex Serum/Plasma Optical /Semi- Automated
characteristics automated/Automated Analyzer
Methods for basic chemistry
parameters, Immunoassay
for hormonal and tumour
markers, Blood gases
analyzer for blood gases
42 Clinical Chemistry Triglyceride To assess risk of cardiovascular Serum/Plasma Optical /Semi- Automated
disease (CVD) automated/Automated Analyzer
Methods for basic chemistry
parameters, Immunoassay
for hormonal and tumour
markers, Blood gases
analyzer for blood gases

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SN Test Category/ IV Diagnostic test Test purpose Specimen type Assay format Equipment
Disease used
43 Clinical Chemistry LDL To assess risk of cardiovascular Serum/Plasma Optical /Semi- Automated
disease (CVD) automated/Automated Analyzer
Methods for basic chemistry
parameters, Immunoassay
for hormonal and tumor
markers, Blood gases
analyzer for blood gases
44 Clinical Chemistry HDL To assess risk of cardiovascular Serum/Plasma Optical /Semi- Automated
disease (CVD) automated/Automated Analyzer
Methods for basic chemistry
parameters, Immunoassay
for hormonal and tumour
markers, Blood gases
analyzer for blood gases
45 Clinical Chemistry TSH To screen for hypothyroidism Serum/Plasma Optical /Semi- Automated
and hyperthyroidism automated/Automated Analyzer
Methods for basic chemistry
parameters, Immunoassay
for hormonal and tumour
markers, Blood gases
analyzer for blood gases
46 Clinical Chemistry PTH To regulate calcium level in Serum/Plasma Optical /Semi- Automated
circulation, to determine automated/Automated Analyzer
hyperparathyroidism and Methods for basic chemistry
hypoparathyroidism parameters, Immunoassay
for hormonal and tumour
markers, Blood gases
analyzer for blood gases

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SN Test Category/ IV Diagnostic test Test purpose Specimen type Assay format Equipment
Disease used
47 Clinical Chemistry Amylase/Lipase To assess acute pancreatitis and Serum/Plasma Optical /Semi- Automated
other pancreatic disorders automated/Automated Analyzer
Methods for basic chemistry
parameters, Immunoassay
for hormonal and tumour
markers, Blood gases
analyzer for blood gases
48 Clinical Chemistry CK-MB To determine the myocardial Serum/Plasma Optical /Semi- Automated
infraction automated/Automated Analyzer
Methods for basic chemistry
parameters, Immunoassay
for hormonal and tumour
markers, Blood gases
analyzer for blood gases
49 Clinical Chemistry Folic Acid To determine folate deficiency Serum/Plasma Optical /Semi- Automated
which alter nucleic acid automated/Automated Analyzer
synthesis, methionine Methods for basic chemistry
regeneration, To assess parameters, Immunoassay
megaloblastic anemia for hormonal and tumour
markers, Blood gases
analyzer for blood gases
50 Clinical Chemistry Ferritin To assess Iron deficiency Serum/Plasma Optical /Semi- Automated
anemia and hemochromatosis automated/Automated Analyzer
Methods for basic chemistry
parameters, Immunoassay
for hormonal and tumour
markers, Blood gases
analyzer for blood gases

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SN Test Category/ IV Diagnostic test Test purpose Specimen type Assay format Equipment
Disease used
51 Clinical Chemistry Soluble Transferrin To describe the functional iron Serum/Plasma Optical /Semi- Automated
Receptor status. Polycythemia, hemolytic automated/Automated Analyzer
anemia, thalassemia, hereditary Methods for basic chemistry
spherocytosis, sickle cell parameters, Immunoassay
anemia, megaloblastic anemia for hormonal and tumour
markers, Blood gases
analyzer for blood gases
52 Clinical Chemistry Blood gases (blood To monitor treatment for lung Whole blood Optical /Semi- Automated
PH, CO2, O2) disease. To detect an acid-base automated/Automated Analyzer
imbalance in blood. To evaluate Methods for basic chemistry
the effectiveness of oxygen parameters, Immunoassay
therapy for hormonal and tumour
markers, Blood gases
analyzer for blood gases
53 Clinical Chemistry Hb A1C To diagnose and monitor Serum/Plasma Optical /Semi- Automated
diabetes mellitus automated/Automated Analyzer
Methods for basic chemistry
parameters, Immunoassay
for hormonal and tumour
markers, Blood gases
analyzer for blood gases
54 Clinical Chemistry Iron Used in the diagnosis and Serum/Plasma Optical /Semi- Automated
treatment of diseases such as automated/Automated Analyzer
iron deficiency anemia and Methods for basic chemistry
hemochromatosis parameters, Immunoassay
for hormonal and tumour
markers, Blood gases
analyzer for blood gases

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SN Test Category/ IV Diagnostic test Test purpose Specimen type Assay format Equipment
Disease used
55 Clinical Chemistry AFP Important part in the risk Serum/Plasma Optical /Semi- Automated
assessment for trisomy 21 in the automated/Automated Analyzer
second trimester of pregnancy Methods for basic chemistry
together with hCG-β. To detect parameters, Immunoassay
and monitor testicular cancer. for hormonal and tumour
To detect and monitor markers, Blood gases
Hepatocellular cancer analyzer for blood gases
56 Clinical Chemistry Vitamin D To monitor bone-malformation Serum/Plasma Optical /Semi- Automated
(rickets). An aid in the automated/Automated Analyzer
assessment of bone metabolism Methods for basic chemistry
parameters, Immunoassay
for hormonal and tumour
markers, Blood gases
analyzer for blood gases
57 Clinical Chemistry CA-15 An aid in the early detection of Serum/Plasma Optical /Semi- Automated
recurrence in previously treated automated/Automated Analyzer
stage II and III breast cancer Methods for basic chemistry
patients. For monitoring parameters, Immunoassay
response to therapy in metastatic for hormonal and tumour
breast cancer patients markers, Blood gases
analyzer for blood gases
58 Clinical Chemistry Vitamin B-12 Used to confirm the diagnosis of Serum/Plasma Optical /Semi- Automated
vitamin B12 deficiency. To automated/Automated Analyzer
assess megaloblastic anemia Methods for basic chemistry
parameters, Immunoassay
for hormonal and tumour
markers, Blood gases
analyzer for blood gases

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SN Test Category/ IV Diagnostic test Test purpose Specimen type Assay format Equipment
Disease used
59 Clinical Chemistry CEA To detect colorectal Serum/Plasma Optical /Semi- Automated
adenocarcinoma. Occur in automated/Automated Analyzer
non-malignant diseases of the Methods for basic chemistry
intestine, the pancreas, the liver, parameters, Immunoassay
and the lungs. for hormonal and tumour
markers, Blood gases
analyzer for blood gases
60 Clinical Chemistry CA-19 Primarily used in the Serum/Plasma Optical /Semi- Automated
management of pancreatic automated/Automated Analyzer
cancer. To detect obstructive Methods for basic chemistry
jaundice as alternative test parameters, Immunoassay
for hormonal and tumour
markers, Blood gases
analyzer for blood gases
61 Clinical Chemistry CA-125 An aid in the detection of Serum/Plasma Optical /Semi- Automated
residual or recurrent ovarian automated/Automated Analyzer
carcinoma Methods for basic chemistry
parameters, Immunoassay
for hormonal and tumour
markers, Blood gases
analyzer for blood gases
62 Clinical Chemistry CA-126 To monitor malignancies of the Serum/Plasma Optical /Semi- Automated
endometrium, breast, automated/Automated Analyzer
gastrointestinal tract Methods for basic chemistry
parameters, Immunoassay
for hormonal and tumour
markers, Blood gases
analyzer for blood gases

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SN Test Category/ IV Diagnostic test Test purpose Specimen type Assay format Equipment
Disease used

63 Clinical Chemistry TPSA/FPSA Aid to detect inflammation or Serum/Plasma Optical /Semi- Automated
trauma of the prostate. To automated/Automated Analyzer
monitor prostate cancer Methods for basic chemistry
parameters, Immunoassay
for hormonal and tumour
markers, Blood gases
analyzer for blood gases
64 HIV Qualitative HIV For the diagnosis of HIV Capillary whole Nucleic Acid Amplification mWRD
virological nucleic infection in infants < 18 months blood/Venous whole Test (HIV/EID)
acid test (Early Infant of age blood/Dried blood
Diagnosis for HIV spots
(EID) )
65 HIV HIV rapid test For the diagnosis of HIV Whole Rapid chromatography NA
infection: adults, adolescents, blood/serum/plasma
children and infants over 18
months of age
66 Immuno-Hematology Complete Blood To diagnose and monitor anemia Capillary or venous Automated hematology CBC Analyzer
Count (CBC) and polycythemia, To monitor blood. analyzer, total and
the safety of certain drugs, differential counts of white
Clinical marker for certain blood cell (WBC), Red
severe infections red blood cell blood cell (RBC), platelets.
(RBC), platelets, Aid in the
diagnosis of intravascular
hemolysis, renal conditions,
rhabdomyolysis (myoglobinuria)

67 Immuno-hematology Blood Group and Rh To determine A, B and O groups Capillary blood Slide agglutination test NA
and Rh type

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SN Test Category/ IV Diagnostic test Test purpose Specimen type Assay format Equipment
Disease used
68 Immuno-Hematology Prothrombin time and To detect or diagnose a bleeding Citrate plasma Hand-held or automated Coagulation
international disorder or thrombotic disorder coagulation analyzer analyzer
normalized ratio (Prothrombin time)
(PT/INR)
69 Immuno-hematology LYMPHOCYTE For staging advanced HIV Venous whole blood Flowcytometry POC
IMMUNE- disease
PHENOTYPING
(CD4%, CD4#,
CD3%, CD3#, CD8#,
CD8%, CD4/CD8
RATIO & CD45#)
70 Immuno-hematology CD4%, CD8. For monitoring response to Venous whole blood Flowcytometry POC
Antiretroviral therapy. (In
settings where viral load is not
available)
71 Immuno-Hematology Erythrocyte The erythrocyte sedimentation Venous whole blood Automated/ESR stand Disposable
sedimentation rate rate (ESR) is a non-specific test. Plastic Citrated
It is raised in a wide range of ESR Graduated
infectious, inflammatory, pipette tube
degenerative, and malignant
conditions associated with
changes in plasma proteins,
particularly increases in
fibrinogen, immunoglobulins,
and C-reactive protein.

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SN Test Category/ IV Diagnostic test Test purpose Specimen type Assay format Equipment
Disease used
72 Immuno-Hematology Morphology For detection of red blood cell, Capillary and venous Romanowsky stained blood Microscopy
examination white blood cell and platelet whole blood films
(peripheral blood, abnormalities, malignancies and
bone marrow, Biopsy, parasites and for white blood
….) cell differential count
73 Immuno-hematology Blood cross matching To determine blood Whole Antisera for agglutination NA
compatibility for blood blood/serum/plasma
transfusions; Rh typing for
pregnant women
74 Parasitology Wet mount For detection of T. vaginalis Urine Wet smear Microscope
75 Parasitology Peripheral smear for For diagnosis of one or more Capillary/venous Blood Staining Microscope
malaria and other human malaria species blood
parasite detection (P. falciparum, P. vivax, P.
malariae, P. ovale) and Borrela
spps, For filarial parasite
detection, For detection of
trypomastigotes stage of T.b.
gambiense
76 Parasitology Peripheral smear for For filarial parasite detection, Capillary Blood /CSF Staining of thick blood film Microscope
malaria and other For detection of trypomastigotes
parasite detection stage of T.b. gambiense
77 Parasitology Direct microscopy and Microscopy of fresh faeces for Stool/faeces Wet smear Microscope
formol-ether detection of trophozoites, ova,
concentration of cysts &larvae of the parasite
faeces for ova or
parasite
78 Parasitology Skin snip For detection of microfilariae of Skin snip Wet smear Microscope
O. volvulus
79 SARS COV-2 (COVID- COVID-19 testing Diagnosis of SARS COV-2 Nasopharyngeal/Oro Nucleic Acid Amplification Automated
19) pharyngeal specimens Test (RT PCR)

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SN Test Category/ IV Diagnostic test Test purpose Specimen type Assay format Equipment
Disease used
80 Serology/Immunology Pregnancy test Pregnancy, uterine Ca Urine Rapid chromatography/Strip NA
test
81 Serology/Immunology Hepatitis B surface Screening for acute and chronic Serum Rapid chromatography/ Test NA
antigen (HBsAg) hepatitis B (HBV) infection: Cassette
infants over 12 months of age,
children, adolescents, adults
82 Serology/Immunology Hepatitis C (Anti- Screening for HCV infection: Serum Rapid chromatography/ Test NA
HCV antibody) infants over 18 months of age, Cassette
children, adolescents, adults
83 Serology/Immunology Human Papilloma Used for cervical cancer Serum Rapid chromatography NA
Virus screening
84 Serology/Immunology Cryptococcal antigen For screening and diagnosis of Serum Rapid chromatography/ Test NA
test cryptococcal meningitis in Cassette
people living with advanced
HIV disease
85 Serology/Immunology Direct Coombs test The direct Coombs test is used Whole Agglutination NA
to test for autoimmune blood/serum/plasma
hemolytic anemia
86 Serology/Immunology Indirect Coombs test The indirect Coombs test is used Whole Agglutination NA
in prenatal testing of pregnant blood/serum/plasma
women and in testing prior to a
blood transfusion
87 Serology/Immunology H. pylori Ag/Ab Look for H. pylori bacteria in Stool Rapid chromatography/ Test NA
the digestive tract, Cassette
88 Serology/Immunology Salmonella (Widal Diagnosis of typhoid fever Serum Rapid chromatography/ Test NA
Test (H, O)) Cassette
89 Serology/Immunology Proteus Weil Felix Diagnosis of typhus fever Serum Rapid chromatography/Test NA
Test- OX19 Cassette

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SN Test Category/ IV Diagnostic test Test purpose Specimen type Assay format Equipment
Disease used
90 Serology/Immunology Occult blood Occult blood in the stool may Stool Rapid chromatography/ Test NA
indicate colon cancer or polyps Cassette
in the colon or rectum though
not all cancers or polyps’ bleed.
91 Serology/Immunology ASO (ANTI- To help determine whether you Serum Rapid chromatography NA
STREPTOLYSIN O) have had a recent strep infection
with the bacteria group A
Streptococcus; to help diagnose
complications resulting from a
strep infection such as rheumatic
fever or glomerulonephritis, a
form of kidney disease
92 Serology/Immunology Rheumatoid Factor An RF test is most often used to Serum Rapid chromatography NA
(RF) help diagnose rheumatoid
arthritis

93 Serology/Immunology complement blood test To measure the levels of a Serum Optical /Semi- Automated
specific type of compliment automated/Automated Analyzer
protein in your blood (eg. C3 Methods
proteins)
94 Urinalysis Urinalysis/dipstick To detect urinary tract infections urine Multi- parameter Strip N/A
(dipstick
95 Urinalysis Urine Microscopic Microscopic Urine sediment Urine Microscopy Microscopy
examination for detection of S.
haematobium, cells and
infectious agents
96 Urinalysis 24-hrs urine protein For the quantitative assessment 24-hrs Urine Optical /Semi- Automated
of 24-hrs urine protein automated/Automated Analyzer
Methods

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 3.9 Standalone Reference Laboratories

The standalone reference laboratories include the National and Regional Reference Laboratories. These laboratories are organized to provide
referral laboratory services that embraces more advanced, comprehensive and specialized laboratory tests. The arrangement of essential diagnostic
tests for these reference laboratories differs from the other level laboratories as they have more advanced infrastructure including sophisticated
equipment and staffed with highly qualified personnel. Furthermore, they are expected to support health researches including survey and
surveillance activities as well as responsible for the detection and characterization of emerging and re-emerging infectious pathogens to guide
effective responses to public health emergency events.

3.9.1 List of Laboratory Tests at Regional Reference Laboratories

SN Test IV Diagnostic test Test purpose Specimen Assay format Equipment

Category/Dise type used
ase
1 Bacteriology & Culture /aerobic and Initial step in detection and Urine, blood, Culture Traditional
Mycology (AST) identification of bacterial and fungal pus, Stool, manual
species for selection of appropriate Sputum spinal techniques and
antibiotic regimens fluid, or Automated
discharge from
the vagina or
penis, etc.

2 Bacteriology & Genus and species For the identification of the genus or Isolates from A range of biochemical tests that Automated /
Mycology identification of bacteria species of bacteria from cultured bacterial or may be performed manually or manual.
and fungi isolates cultures on automated equipment.

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SN Test IV Diagnostic test Test purpose Specimen Assay format Equipment
Category/ type used
Disease
3 Bacteriology & Genus and species For the detection and identification of Serum, Stool, Nucleic acid extraction from RT- PCR
Mycology identification of bacteria B. anthracis CSF, Nasal specimens followed by RT-PCR machine
B. anthracis swab, sputum,
Ascetic fluid,
Swab from
cutaneous,
vesicular lesion
4 Bacteriology & Genus and species For the detection and identification of Stool, Rectal Stool culture, PCR (from Manual /
Mycology identification of bacteria V. cholerae 01/0139 swab and water isolates) automated
Vibrio cholera O1 and
O39
5 Bacteriology & Genus and species For the detection and identification Stool Stool culture Microscopy,
Mycology identification of bacteria dysentery causative agents like Bacterial
Dysentery causative Shigellosis Culture, and
agents like Shigellosis Serological
test
6 Bacteriology & Genus and species For the detection and identification CSF, Blood Serological test, culture, PCR Microscopy(A
Mycology identification of bacterial causative agents for bacterial meningitis ). Bacterial
Meningitis Culture
(N.menigitidis,S.pneumon
ae,H.influenza,E.coli)
7 Bacteriology & Genus and species Genus and species identification of Blood, CSF, ELISA, PCR ELISA, PCR
Mycology identification of brucellosis
Brucellosis
8 Clinical CEA To detect colorectal adenocarcinoma. Serum/Plasma Optical /Semi- Automated
Chemistry Occur in non-malignant diseases of the automated/Automated Methods Analyzer
intestine, the pancreas, the liver, and the for basic chemistry parameters,
lungs. Immunoassay for hormonal and
tumor markers.

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SN Test IV Diagnostic test Test purpose Specimen Assay format Equipment
Category/ type used
Disease
9 Clinical CA-15 An aid in the early detection of Serum/Plasma Optical /Semi- Automated
Chemistry recurrence in previously treated stage II automated/Automated Methods Analyzer
and III breast cancer patients. For for basic chemistry parameters,
monitoring response to therapy in Immunoassay for hormonal and
metastatic breast cancer patients tumor markers.

10 Clinical CA-19 Primarily used in the management of Serum/Plasma Optical /Semi- Automated
Chemistry pancreatic cancer. To detect obstructive automated/Automated Methods Analyzer
jaundice as alternative test for basic chemistry parameters,
Immunoassay for hormonal and
tumor markers.
11 Clinical CA-125 An aid in the detection of residual or Serum/Plasma Optical /Semi- Automated
Chemistry recurrent ovarian carcinoma. To automated/Automated Methods Analyzer
monitor malignancies of the for basic chemistry parameters,
endometrium, breast, gastrointestinal Immunoassay for hormonal and
tract tumor markers.
12 Clinical TPSA/FPSA Aid to detect inflammation or trauma of Serum/Plasma Optical /Semi- Automated
Chemistry the prostate. To monitor prostate cancer automated/Automated Methods Analyzer
for basic chemistry parameters,
Immunoassay for hormonal and
tumor markers.
13 Clinical GGT To assess hepatobiliary function. To Serum/Plasma Optical /Semi- Automated
Chemistry distinguish between bone and automated/Automated Methods Analyzer
hepatobiliary causes of raised ALP for basic chemistry parameters,
Immunoassay for hormonal and
tumor markers.

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SN Test IV Diagnostic test Test purpose Specimen Assay format Equipment
Category/ type used
Disease
14 Clinical β- HCG Aid in early detection and monitoring of Serum/Plasma Optical /Semi- Automated
Chemistry pregnancy, oncology (to serve the automated/Automated Methods Analyzer
management of patients with for basic chemistry parameters,
trophoblastic diseases). Immunoassay for hormonal and
tumor markers.
15 Clinical T3/FT3 To screen for hypothyroidism and Serum/Plasma Optical /Semi- Automated
Chemistry hyperthyroidism automated/Automated Methods Analyzer
for basic chemistry parameters,
Immunoassay for hormonal and
tumor markers.
16 Clinical T4/FT4 To screen for hypothyroidism and Serum/Plasma Optical /Semi- Automated
Chemistry hyperthyroidism automated/Automated Methods Analyzer
for basic chemistry parameters,
Immunoassay for hormonal and
tumor markers.
17 Clinical Amylase/Lipase To assess acute pancreatitis and other Serum/Plasma Optical /Semi- Automated
Chemistry pancreatic disorders automated/Automated Methods Analyzer
for basic chemistry parameters,
Immunoassay for hormonal and
tumor markers.
18 Clinical Iron Used in the diagnosis and treatment of Serum/Plasma Optical /Semi- Automated
Chemistry diseases such as iron deficiency anemia automated/Automated Methods Analyzer
and hemochromatosis for basic chemistry parameters,
Immunoassay for hormonal and
tumor markers.

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SN Test IV Diagnostic test Test purpose Specimen Assay format Equipment
Category/ type used
Disease
19 Clinical Hb A1C To diagnose and monitor diabetes Serum/Plasma Optical /Semi- Automated
Chemistry mellitus automated/Automated Methods Analyzer
for basic chemistry parameters,
Immunoassay for hormonal and
tumor markers.
20 Clinical Estradiol Utilized clinically in the elucidation of Serum/Plasma Optical /Semi- Automated
Chemistry fertility disorders in the automated/Automated Methods Analyzer
hypothalamus-pituitary-gonad axis, for basic chemistry parameters,
gynecomastia, oestrogen-producing Immunoassay for hormonal and
ovarian and testicular tumors. tumor markers.
21 Clinical Cortisol Used in the regulation of many essential Serum/plasma/ Optical /Semi- Automated
Chemistry physiological processes, including urine automated/Automated Methods Analyzer
energy metabolism, maintenance of for basic chemistry parameters,
electrolyte balance and blood pressure, Immunoassay for hormonal and
immunomodulation and stress tumor markers.
responses, cell proliferation
22 Clinical Vitamin B-12 Used to confirm the diagnosis of Serum/Plasma Optical /Semi- Automated
Chemistry vitamin B12 deficiency. To assess automated/Automated Methods Analyzer
megaloblastic anemia for basic chemistry parameters,
Immunoassay for hormonal and
tumor markers.
23 Clinical Folic Acid To determine folate deficiency which Serum/Plasma Optical /Semi- Automated
Chemistry alter nucleic acid synthesis, methionine automated/Automated Methods Analyzer
regeneration. To assess megaloblastic for basic chemistry parameters,
anemia Immunoassay for hormonal and
tumor markers.

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SN Test IV Diagnostic test Test purpose Specimen Assay format Equipment
Category/ type used
Disease
24 Clinical Ferritin To assess Iron deficiency anemia and Serum/Plasma Optical /Semi- Automated
Chemistry hemochromatosis automated/Automated Methods Analyzer
for basic chemistry parameters,
Immunoassay for hormonal and
tumor markers.
25 Clinical Soluble Transferrin To describe the functional iron status. Serum/Plasma Optical /Semi- Automated
Chemistry Receptor Polycythemia, hemolytic anemia, automated/Automated Methods Analyzer
thalassemia, hereditary spherocytosis, for basic chemistry parameters,
sickle cell anemia, megaloblastic Immunoassay for hormonal and
anemia tumor markers.

26 Clinical CK-MB To determine myocardial infraction Serum/Plasma Optical /Semi- Automated

Chemistry automated/Automated Methods Analyzer
for basic chemistry parameters,
Immunoassay for hormonal and
tumor markers.
27 Clinical CK/CPK To determine the myocardial infraction Serum/Plasma Optical /Semi- Automated
Chemistry automated/Automated Methods Analyzer
for basic chemistry parameters,
Immunoassay for hormonal and
tumor markers.
28 Clinical Testosterone To monitor male secondary sex Serum/Plasma Optical /Semi- Automated
Chemistry characteristics automated/Automated Methods Analyzer
for basic chemistry parameters,
Immunoassay for hormonal and
tumor markers.

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SN Test IV Diagnostic test Test purpose Specimen Assay format Equipment
Category/ type used
Disease
29 Clinical PTH To regulate calcium level in circulation, Serum/Plasma Optical /Semi- Automated
Chemistry to determine hyperparathyroidism and automated/Automated Methods Analyzer
hypoparathyroidism for basic chemistry parameters,
Immunoassay for hormonal and
tumor markers.
30 Clinical Prolactin Utilized in postpartum to lactation, Serum/Plasma Optical /Semi- Automated
Chemistry affects glucose and lipid metabolism automated/Automated Methods Analyzer
for basic chemistry parameters,
Immunoassay for hormonal and
tumor markers.
31 Clinical Vitamin D To monitor bone-malformation Optical /Semi- Automated
Chemistry (rickets). An aid in the assessment of automated/Automated Methods Analyzer
bone metabolism for basic chemistry parameters,
Immunoassay for hormonal and
tumor markers.
32 Hepatitis B Viral Load/Quantitative Treatment Monitoring Plasma/Serum Nucleic Acid Amplification Test Abbott/Roche
(RT PCR)
33 HIV Viral Load/Quantitative Treatment Monitoring Plasma Nucleic Acid Amplification Test Abbott/Roche
(RT PCR)
34 HIV Qualitative HIV Diagnosis Dry Blood Spot Nucleic Acid Amplification Test Abbott/Roche
virological nucleic acid (DBS) (RT PCR)
test (Early Infant
Diagnosis for HIV (EID) )

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SN Test IV Diagnostic test Test purpose Specimen Assay format Equipment
Category/ type used
Disease
35 Human Molecular testing For the diagnosis of human papilloma Cervical swab Nucleic Acid Amplification Test Abbott/Roche
papilloma virus virus (RT PCR)

36 Immuno- CBC To evaluate overall health and to detect EDTA whole Fully Automated hematology Fully
hematology a wide range of disorders, including blood. analyzer Automated
anemia, infections, leukemia’s, red hematology
blood cell, white blood cell and platelet analyzer
abnormalities and primary immune
disorders
37 Immuno- Lymphocyte immune- Used to monitor immune deficiency EDTA blood Automated flow cytometer Automated
hematology phenotyping (CD4%, therapy. flow
CD4#, CD3%, CD3#, cytometer
CD8#, CD8%, CD4/CD8
ratio & CD45#)
38 Immuno- D-Dimer To diagnose disseminated intravascular Citrate plasma Fully Automated coagulation Fully
hematology coagulation analyzer Automated
hematology
analyzer
39 Immuno- Sickle cell testing To aid in the diagnosis of sickle cell Venous EDTA Sodium metabisulfite slide test, Fully
hematology anemia, sickle whole blood Hemoglobin Solubility Automated
hematology
analyzer
40 Molecular test Genus and species Genus and species identification for Bacterial RT PCR RT-PCR
identification of Pertussis bacterial whooping cough isolate,
Nasopharyngea
l
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SN Test IV Diagnostic test Test purpose Specimen Assay format Equipment
Category/ type used
Disease
41 Parasitology Molecular test for PCR (gold standard) for malaria EDTA Blood PCR PCR
malaria confirmation and species machine
determination.
42 Parasitology Culture and PCR for For the investigation of cutaneous or Bone marrow, Culture and PCR PCR
Leishmaniases/for visceral leishmaniasis lymph, machine
endemic regions spleen, liver,
tissue.
43 Parasitology Others Molecular tests For species determinations & Blood, CSF, Culture and PCR PCR
conformation of parasites any body machine
fluids
44 SARS COV-2 COVID-19 testing Diagnosis Nasopharynge Nucleic Acid Amplification Automated/
(COVID-19) molecular al/Oro Test (RT PCR) Manual
pharyngeal
specimens
45 TB Molecular WRD test Diagnosis Sputum Nucleic Acid Amplification mWRD
Test
46 TB Mycobacterium Diagnosis and Treatment monitoring Sputum/Body Bacterial Culture (LJ and BD MIGIT
tuberculosis bacteria fluid MGIT) 960/Manual
culture
47 TB Drug susceptibility To detect resistance to first-line Bacterial Bacterial Culture (LJ and BD MIGIT
testing with MTB culture of MGIT) 960/Manual
culture MTB
48 TB MTB DNA mutations For the detection of resistance for Sputum/Bacte Molecular line probe assay Twincubator
associated with second-line anti-TB medicines rial culture of (LPA)
resistance MTB
49 Other newly emerging tests of clinical and public health importance Latest method and technology

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3.9.2 List of Laboratory Tests at National Reference Laboratories

SN Test IV Diagnostic test Test purpose Specimen type Assay format Equipment
Category/Dise used
ase
1 Bacteriology & Genus and species For the identification of the genus Isolates from A range of biochemical tests that Automated /
Mycology identification of bacteria or species of bacteria or fungi from bacterial or fungal may be performed manually or on manual.
and fung cultured isolates cultures automated equipment.

2 Bacteriology & Culture and For the detection of bacterial and Bacterial isolate, Blood culture bottle in an Automated
Mycology Antimicrobial fungal bloodstream infections Venous whole incubator followed by recovery of /manual
susceptibility testing (sepsis) blood collected isolates.
(AST) aseptically.
3 Bacteriology & Genus and species For the detection and identification Bacterial isolate, Stool culture, PCR (from isolates) RT- PCR
Mycology identification of bacteria of V. Cholera 01/0139 Stool, Rectal swab machine
Vibrio cholera O1 and and water
O39
4 Bacteriology & Genus and species For the detection and identification Bacterial isolate, Stool culture Microscopy,
Mycology identification of bacteria of dysentery causing agents like Stool Bacterial Culture,
Dysentery causative Shigellosis and Serological
agents like Shigellosis test
5 Bacteriology & Genus and species For the detection and identification Bacterial isolate, Culture, PCR Bacterial Culture,
Mycology identification of bacterial of bacterial meningitis causing CSF, Blood RT-PCR
Meningitis agents
(N.menigitidis,S.pneumon
ae,H.influenza,E.coli)

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SN Test IV Diagnostic test Test purpose Specimen type Assay format Equipment
Category/ used
Disease
6 Bacteriology & Culture anaerobic Initial step in detection and Bacterial isolate, Culture Anaerobic
Mycology identification of bacterial and normally sterile chamber and
fungal species for selection of body fluids, incubator.
appropriate antibiotic regimens Surgical
specimens from
sites that normally
are sterile, Deep
abscess contents
taken aseptically,
Aspirates from
deep wounds
7 Bacteriology & Genus and species For the detection and identification Bacterial isolate Nucleic acid extraction from RT- PCR
Mycology identification of bacteria of B. anthracis Serum, Stool, specimens followed by RT-PCR machine
B. anthracis CSF, Nasal swab,
sputum, Ascetic
fluid, Swab from
cutaneous,
vesicular lesion
8 Bacteriology & Genus and species Genus and species identification of Bacterial isolate, ELISA, RT-PCR ELISA, RT-PCR
Mycology identification of brucellosis Blood, CSF,
Brucellosis

9 Bacteriology & Genus and species Checks for bacterial whooping Bacterial isolate, RT PCR RT-PCR
Mycology identification of Pertussis cough Nasopharyngeal

10 Bacteriology & Fungal culture Checks for the growth of fungal Fungal isolate, Culture Manual
Mycology isolates Skin, scalp, nail
scraping

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SN Test IV Diagnostic test Test purpose Specimen type Assay format Equipment
Category/ used
Disease
11 Clinical T3/FT3 To screen for hypothyroidism and Serum/Plasma Optical /Semi- Semi-
chemistry hyperthyroidism automated/Automated Methods automated/Autom
for basic chemistry parameters, ated Analyzer
Immunoassay for hormonal and
tumor markers.

12 Clinical T4/FT4 To screen for hypothyroidism and Serum/Plasma Optical /Semi- Semi-
chemistry hyperthyroidism automated/Automated Methods automated/Autom
for basic chemistry parameters, ated Analyzer
Immunoassay for hormonal and
tumor markers.

13 Clinical TSH To screen for hypothyroidism and Serum/Plasma Optical /Semi- Semi-
chemistry hyperthyroidism automated/Automated Methods automated/Autom
for basic chemistry parameters, ated Analyzer
Immunoassay for hormonal and
tumor markers.

14 Clinical FSH Used to indicate congenital diseases Serum/Plasma Optical /Semi- Semi-
chemistry with chromosome aberrations, automated/Automated Methods automated/Autom
polycystic ovaries (PCO), for basic chemistry parameters, ated Analyzer
amenorrhea (causes), and Immunoassay for hormonal and
menopausal syndrome tumor markers.

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SN Test IV Diagnostic test Test purpose Specimen type Assay format Equipment
Category/ used
Disease
15 Clinical LH Used to indicate congenital diseases Serum/Plasma Optical /Semi- Semi-
chemistry with chromosome aberrations, automated/Automated Methods automated/Autom
polycystic ovaries (PCO), for basic chemistry parameters, ated Analyzer
amenorrhea (causes), and Immunoassay for hormonal and
menopausal syndrome tumor markers.
16 Clinical AFP Important part in the risk Serum/Plasma Optical /Semi- Semi-
chemistry assessment for trisomy 21 in the automated/Automated Methods automated/Autom
second trimester of pregnancy for basic chemistry parameters, ated Analyzer
together with hCG-β. To detect and Immunoassay for hormonal and
monitor testicular cancer. To detect tumor markers.
and monitor Hepatocellular cancer
17 Clinical Iron Used in the diagnosis and treatment Serum/Plasma Optical /Semi- Semi-
chemistry of diseases such as iron deficiency automated/Automated Methods automated/Autom
anemia and hemochromatosis for basic chemistry parameters, ated Analyzer
Immunoassay for hormonal and
tumor markers.
18 Clinical Soluble Transferrin To describe the functional iron Serum/Plasma Optical /Semi- Semi-
chemistry Receptor status. Polycythaemia, hemolytic automated/Automated Methods automated/Autom
anemia, thalassemia, hereditary for basic chemistry parameters, ated Analyzer
spherocytosis, sickle cell anaemia, Immunoassay for hormonal and
megaloblastic anemia tumor markers.

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SN Test IV Diagnostic test Test purpose Specimen type Assay format Equipment
Category/ used
Disease
19 Clinical CEA To detect colorectal Serum/Plasma Optical /Semi- Semi-
chemistry adenocarcinoma. Occur in automated/Automated Methods automated/Autom
non-malignant diseases of the for basic chemistry parameters, ated Analyzer
intestine, the pancreas, the liver, Immunoassay for hormonal and
and the lungs. tumor markers.

20 Clinical CA-15 An aid in the early detection of Serum/Plasma Optical /Semi- Semi-
chemistry recurrence in previously treated automated/Automated Methods automated/Autom
stage II and III breast cancer for basic chemistry parameters, ated Analyzer
patients. For monitoring response to Immunoassay for hormonal and
therapy in metastatic breast cancer tumor markers.
patients
21 Clinical CA-19 Primarily used in the management Serum/Plasma Optical /Semi- Semi-
chemistry of pancreatic cancer. To detect automated/Automated Methods automated/Autom
obstructive jaundice as alternative for basic chemistry parameters, ated Analyzer
test Immunoassay for hormonal and
tumor markers.

22 Clinical CA-125 An aid in the detection of residual Serum/Plasma Optical /Semi- Semi-
chemistry or recurrent ovarian carcinoma. To automated/Automated Methods automated/Autom
monitor malignancies of the for basic chemistry parameters, ated Analyzer
endometrium, breast, Immunoassay for hormonal and
gastrointestinal tract tumor markers.

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SN Test IV Diagnostic test Test purpose Specimen type Assay format Equipment
Category/ used
Disease
23 Clinical Hb A1C To diagnose and monitor diabetes Serum/Plasma Optical /Semi- Semi-
chemistry mellitus automated/Automated Methods automated/Autom
for basic chemistry parameters, ated Analyzer
Immunoassay for hormonal and
tumor markers.

24 Clinical Cholesterol To assess risk of cardiovascular Serum/Plasma Optical /Semi- Semi-

chemistry disease (CVD) automated/Automated Methods automated/Autom
for basic chemistry parameters, ated Analyzer
Immunoassay for hormonal and
tumor markers.

25 Clinical Triglyceride To assess risk of cardiovascular Serum/Plasma Optical /Semi- Semi-

chemistry disease (CVD) automated/Automated Methods automated/Autom
for basic chemistry parameters, ated Analyzer
Immunoassay for hormonal and
tumor markers.

26 Clinical LDL To assess risk of cardiovascular Serum/Plasma Optical /Semi- Semi-

chemistry disease (CVD) automated/Automated Methods automated/Autom
for basic chemistry parameters, ated Analyzer
Immunoassay for hormonal and
tumor markers.

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SN Test IV Diagnostic test Test purpose Specimen type Assay format Equipment
Category/ used
Disease
27 Clinical HDL To assess risk of cardiovascular Serum/Plasma Optical /Semi- Semi-
chemistry disease (CVD) automated/Automated Methods automated/Autom
for basic chemistry parameters, ated Analyzer
Immunoassay for hormonal and
tumor markers.
28 Clinical LDH To assess metabolic acidosis, Serum/Plasma Optical /Semi- Semi-
chemistry diabetic keto-acidosis, sepsis and automated/Automated Methods automated/Autom
dehydration for basic chemistry parameters, ated Analyzer
Immunoassay for hormonal and
tumor markers.
29 Clinical TPSA/FPSA Aid to detect inflammation or Serum/Plasma Optical /Semi- Semi-
chemistry trauma of the prostate. To monitor automated/Automated Methods automated/Autom
prostate cancer for basic chemistry parameters, ated Analyzer
Immunoassay for hormonal and
tumor markers.
30 Clinical GGT To assess hepatobiliary function. To Serum/Plasma Optical /Semi- Semi-
chemistry distinguish between bone and automated/Automated Methods automated/Autom
hepatobiliary causes of raised ALP for basic chemistry parameters, ated Analyzer
Immunoassay for hormonal and
tumor markers.
31 Clinical CK-MB To determine the myocardial Serum/Plasma Optical /Semi- Semi-
chemistry infraction automated/Automated Methods automated/Autom
for basic chemistry parameters, ated Analyzer
Immunoassay for hormonal and
tumor markers.

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SN Test IV Diagnostic test Test purpose Specimen type Assay format Equipment
Category/ used
Disease
32 Clinical CK/CPK To determine the myocardial Serum/Plasma Optical /Semi- Semi-
chemistry infraction automated/Automated Methods automated/Autom
for basic chemistry parameters, ated Analyzer
Immunoassay for hormonal and
tumor markers.
33 Clinical Amylase/Lipase To assess acute pancreatitis and Serum/Plasma Optical /Semi- Semi-
chemistry other pancreatic disorders automated/Automated Methods automated/Autom
for basic chemistry parameters, ated Analyzer
Immunoassay for hormonal and
tumor markers.
34 Clinical Ferritin To assess Iron deficiency anemia Serum/Plasma Optical /Semi- Semi-
chemistry and hemochromatosis automated/Automated Methods automated/Autom
for basic chemistry parameters, ated Analyzer
Immunoassay for hormonal and
tumor markers.
35 Clinical Estradiol Utilized clinically in the elucidation Serum/Plasma Optical /Semi- Semi-
chemistry of fertility disorders in the automated/Automated Methods automated/Autom
hypothalamus-pituitary-gonad axis, for basic chemistry parameters, ated Analyzer
gynecomastia, oestrogen-producing Immunoassay for hormonal and
ovarian and testicular tumors. tumor markers.

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SN Test IV Diagnostic test Test purpose Specimen type Assay format Equipment
Category/ used
Disease
36 Clinical Cortisol Used in the regulation of many Serum/plasma/ Optical /Semi- Semi-
chemistry essential physiological urine automated/Automated automated/Auto
processes, including energy Methods for basic chemistry mated Analyzer
metabolism, maintenance of parameters, Immunoassay for
electrolyte balance and blood hormonal and tumor markers.
pressure, immunomodulation
and stress responses, cell
proliferation
37 Clinical β- HCG Aid in early detection and Serum/Plasma Optical /Semi- Semi-
chemistry monitoring of pregnancy, automated/Automated automated/Auto
oncology (to serve the Methods for basic chemistry mated Analyzer
management of patients with parameters, Immunoassay for
trophoblastic diseases). hormonal and tumor markers.
38 Clinical Testosterone To monitor male secondary sex Serum/Plasma Optical /Semi- Semi-
chemistry characteristics automated/Automated automated/Auto
Methods for basic chemistry mated Analyzer
parameters, Immunoassay for
hormonal and tumor markers.
39 Clinical PTH To regulate calcium level in Serum/Plasma Optical /Semi- Semi-
chemistry circulation, to determine automated/Automated automated/Auto
hyperparathyroidism and Methods for basic chemistry mated Analyzer
hypoparathyroidism parameters, Immunoassay for
hormonal and tumor markers.

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SN Test IV Diagnostic test Test purpose Specimen type Assay format Equipment
Category/ used
Disease
40 Clinical Vitamin B-12 Used to confirm the diagnosis of Serum/Plasma Optical /Semi- Semi-
chemistry vitamin B12 deficiency. To assess automated/Automated Methods automated/Autom
megaloblastic anemia for basic chemistry parameters, ated Analyzer
Immunoassay for hormonal and
tumor markers.

41 Clinical Folic Acid To determine folate deficiency Serum/Plasma Optical /Semi- Semi-
chemistry which alter nucleic acid synthesis, automated/Automated Methods automated/Autom
methionine regeneration. To assess for basic chemistry parameters, ated Analyzer
megaloblastic anemia Immunoassay for hormonal and
tumor markers.
42 Clinical Phenobarbital Essential to achieve maximal Serum/Plasma Optical /Semi- Semi-
chemistry seizure control automated/Automated Methods automated/Autom
for basic chemistry parameters, ated Analyzer
Immunoassay for hormonal and
tumor markers.
43 Clinical Phenytoin For seizure control Serum/Plasma Optical /Semi- Semi-
chemistry automated/Automated Methods automated/Autom
for basic chemistry parameters, ated Analyzer
Immunoassay for hormonal and
tumor markers.

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SN Test IV Diagnostic test Test purpose Specimen type Assay format Equipment
Category/ used
Disease
44 Clinical Lithium To ensure compliance and to avoid Serum/Plasma Optical /Semi- Semi-
chemistry toxicity in the treatment of manic- automated/Automated Methods automated/Autom
depressive psychosis. for basic chemistry parameters, ated Analyzer
Immunoassay for hormonal and
tumor markers.
45 Clinical Valproic acid For the treatment of primary and Serum/Plasma Optical /Semi- Semi-
chemistry secondary generalized seizures automated/Automated Methods automated/Autom
for basic chemistry parameters, ated Analyzer
Immunoassay for hormonal and
tumor markers.
46 Clinical Protein electrophoresis Used to direct detect accurate Urine/serum Optical /Semi- Semi-
chemistry relative quantification of individual automated/Automated Methods automated/Autom
protein fractions. for basic chemistry parameters, ated Analyzer
Immunoassay for hormonal and
tumor markers.
47 Clinical Hemoglobin variant Used for the separation of the Whole blood Optical /Semi- Semi-
chemistry normal hemoglobin (A, F and A2) automated/Automated Methods automated/Autom
and for the detection of the major for basic chemistry parameters, ated Analyzer
hemoglobin variants (especially S, Immunoassay for hormonal and
C, E or D) tumor markers.
48 Clinical Capillary immunotyping For the detection and the Urine/serum Optical /Semi- Semi-
chemistry characterization of monoclonal automated/Automated Methods automated/Autom
proteins (immunotyping) for basic chemistry parameters, ated Analyzer
Immunoassay for hormonal and
tumor markers.

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SN Test Category/ IV Diagnostic test Test purpose Specimen type Assay format Equipment used
Disease

49 Clinical Prolactin Utilized in postpartum to lactation, Serum/Plasma Optical /Semi- Semi-

chemistry affects glucose and lipid automated/Automated Methods automated/Autom
metabolism for basic chemistry parameters, ated Analyzer
Immunoassay for hormonal and
tumor markers.
50 Clinical Carbamazepine Used in particular for the treatment Serum/Plasma Optical /Semi- Semi-
chemistry of trigeminal neuralgia, all forms of automated/Automated Methods automated/Autom
partial epilepsy, generalized for basic chemistry parameters, ated Analyzer
tonic-clonic seizures, and simple Immunoassay for hormonal and
and complex partial seizures tumor markers.
51 Genomic Genomic Sequencing Detection of Down Syndrome, Cells, tissue, Whole-genome
Sequencing tumor and multiple pathogens formalin-fixed and sequencing (WGS)
paraffin-embedded
(FFPE) tissue, and
liquid biopsies
52 Hepatitis B Viral Load/Quantitative Treatment Monitoring Plasma/Serum Nucleic Acid Amplification Test Abbott/Roche
(RT PCR)

53 Hepatitis C Viral Load/Quantitative Treatment Monitoring Plasma/Serum Nucleic Acid Amplification Test Abbott/Roche
(RT PCR)
54 HIV Viral Load/Quantitative Treatment Monitoring Plasma Nucleic Acid Amplification Test Abbott/Roche
(RT PCR)
55 HIV Early Infant Diagnosis for Diagnosis Dry Blood Spot Nucleic Acid Amplification Test Abbott/Roche
HIV (EID) (DBS) (RT PCR)

56 HIV Drug resistance Treatment Monitoring Plasma/Serum/Bo Genotypic/Phenotypic Sanger/Illumina

dy fluids

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SN Test IV Diagnostic test Test purpose Specimen type Assay format Equipment
Category/ used
Disease
57 HUMAN Molecular testing For diagnosis of HUMAN Cervical swab Nucleic Acid Amplification Test Abbott/Roche
PAPILLOMA PAPILLOMA VIRUS (RT PCR)
VIRUS
58 Immuno- Lymphocyte Used to monitor Immuno deficiency EDTA whole Automated Flow cytometer Fully automated
Hematology immunophenotyping therapy. blood coagulation
(CD4%, CD4#, CD3%, analyzer
CD3#, CD8#, CD8%,
CD4/CD8 ratio &
CD45#)
59 Immuno- COMPLETE BLOOD To evaluate overall health and to EDTA Fully automated hematology Fully automated
Hematology COUNT (CBC) with detect a wide range of disorders, analyzer hematology
Reticulocyte count. including anemia, infections, analyzer
leukemia’s, red blood cell, white
blood cell and platelet abnormalities
and primary immune disorders

60 Immuno- Haemoglobinopathies To diagnose hemoglobin defect. DBS and whole Isoelectric focusing (IEF) and Fully automated
Hematology screening/testing (in high blood High-performance liquid coagulation
prevalence areas) chromatography (HPLC) analyzer

61 Immuno- Immuno- phenotyping For the diagnosis of hematological EDTA Whole Automated Flowcytometry Fully automated
Hematology malignancy. blood Analyzer coagulation
analyzer
62 Immuno- Flowcytometry cross- For organ transplanting purpose Tissue. Automated Flowcytometry Fully automated
Hematology matching (FCXM) for Analyzer coagulation
transplantation analyzer

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SN Test IV Diagnostic test Test purpose Specimen type Assay format Equipment
Category/ used
Disease
63 Immuno- BCR-ABL Assay for For the diagnosis of chronic Whole blood/ RT-qPCR Fully automated
Hematology CML diagnosis myeloid leukemia, for targeted bonne marrow coagulation
cancer therapy analyzer
64 Immuno- Immunocytochemistry, For diagnosis of Hematological Whole blood/ Automated Stainer and magnifier Fully automated
Hematology Immunohistochemistry malignancies tissue analyzer. coagulation
analyzer
65 Immuno- Cytochemical staining For the diagnosis of Hematological Whole blood/ Manual staining and observing Fully automated
Hematology Immunoglobulin assay malignancies tissue under digital Electron microscopy coagulation
analyzer
66 Immuno- Cytogenetic staining For the diagnosis of hematological Whole blood/ Manual staining and observing Fully automated
Hematology malignancies tissue under digital Electron microscopy coagulation
analyzer
67 Immuno- Sickle cell testing To aid in the diagnosis of sickle cell EDTA whole Sodium metabisulfite slide test, Fully automated
Hematology anemia, sickle blood Hemoglobin solubility coagulation
analyzer
68 Parasitology Molecular test for PCR (gold standard) for malaria EDTA Blood PCR PCR machine
malaria confirmation and species
determination.
69 Parasitology Culture and PCR for For the investigation of cutaneous bone marrow, Culture and PCR Manual
Leishmaniases/for or visceral leishmaniasis lymph, spleen,
endemic regions liver, tissue.

70 Parasitology Molecular test for O. For the detection of microfilariae of Skin snip PCR PCR Machine
volvulus O. volvulus

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SN Test IV Diagnostic test Test purpose Specimen type Assay format Equipment
Category/ used
Disease
71 Parasitology Others Molecular tests For species determinations & Blood, CSF, any culture & PCR PCR machine
conformation of parasites body fluids

72 SARS COV-2 COVID-19 testing Diagnosis Nasopharyngeal/O Nucleic Acid Amplification Test Automated/Manu
(COVID-19) ro pharyngeal (RT PCR) al
specimens

73 TB Molecular WRD test Diagnosis Sputum Nucleic Acid Amplification Test Molecular WRD
(Xpert MTB/RIF Assay) test
74 TB Mycobacterium Diagnosis and Treatment Sputum/Body Bacterial Culture (LJ and MGIT) BD MIGIT
tuberculosis bacteria monitoring fluid 960/Manual
culture

75 TB Drug susceptibility To detect resistance to first-line Bacterial culture Bacterial Culture (LJ and MGIT) BD MIGIT
testing with MTB culture and/or second line anti-TB of MTB 960/Manual
medicines

76 TB MTB DNA mutations For the detection of resistance for Sputum/Bacterial Molecular line probe assay (LPA) Twincubator
associated with resistance second line anti-TB medicines culture of MTB

77 Other newly emerging tests of clinical and Latest method

public health importance and technology

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Implementation Strategies and Revision Requirements

3.10 Implementation Strategies

For effective implementation of the NELDL, designing suitable implementation arrangements,

monitoring and evaluation framework are mandatory. The following recommendations are
forwarded to facilitate the effective implementation of the NELDL at all levels of the Ethiopian
health laboratory system. As is true for all development programs and initiatives the
implementation should be adequately resourced and be based on well aligned and mutually
reinforcing plan of actions with clear roles and responsibilities assigned to all involved
stakeholders and partners. Above all, unwavering commitment, strong leadership and
coordination of activities at all levels of the health system remain the key to success.

3.10.1 Implementation Arrangements

The implementation arrangement of this NELDL will involve all levels of the government
structures for leadership and management of the healthcare system

MOH

 Develop strategies and guide for the seamless implementation of the NELDL.
 Mobilize resources required for the comprehensive implementation of the NELDL.
 Oversee and monitor the proper implementation of the NELDL.

EPHI

 Develop and adopts the NELDL as standard list of laboratory diagnostic tests to be
implemented across all health facilities nationwide.
 Develop additional documents as needed to facilitate the implementation of the NELDL
 Evaluate and validate methods and technologies, and define algorithms to support the
introduction and effective use of diagnostic tests.
 Implement capacity building programs to enhance the implementation of the NELDL.
 Develop standard specifications for test kits and associated supplies including
instruments to be used at the different tiers of the healthcare system.

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  In collaboration with stakeholders, establish reliable system for collection of
data/information on the needs of healthcare facilities for different tests and associated
commodities (Annual testing needs or volumes)
 Strengthen supporting systems for specimen referral linkage and testing services
(laboratory referral networks, transportation and result delivery systems).
 Strengthen system for laboratory equipment management at all levels of the healthcare
system (installation, preventive and curative maintenance services including
management/enforcement of Service Level Agreements established with various
manufacturers/suppliers).
 Monitor and evaluate the implementation of the NELDL’ develop and implement
continuous improvement plans.

EPSS

 Lead and coordinate annual quantification exercises for the procurement of laboratory
commodities including instruments to support the implementation of the NELDL.
 Timely procure and ensure the availability of adequate stock of reagents, consumable
supplies and equipment.
 Implement reliable system for the real-time collection of data on stock status and
consumption of reagents and consumable supplies at all healthcare facilities.
 Monitor and evaluate the effectiveness of the supply chain system for the provision of
uninterrupted diagnostic testing services across all healthcare facilities nationwide.

EFDA

 Provide regulatory oversight and implement appropriate measures to enforce and

ensure adherence to the effective use of the NELDL by all healthcare facilities.

Regional Health Bureau

 Implement capacity building programs to enhance the implementation of the NELDL

 Orient Zonal/Woreda health departments and healthcare facilities on NELDL
implementation requirements.
 Mobilize and allocate the necessary resources

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  In collaboration with EPHI, strengthen supporting systems for specimen referral
linkage and testing services (laboratory referral networks, transportation and result
delivery systems).
 Oversee and monitor the proper implementation of the NELDL within the region.

Regional Public Health Institutes/Regional Reference Laboratories

 Conduct facility readiness assessments on infrastructure, equipment, staffing, etc.

 Develop regional phase-in plans according to facility tier level and diagnostic needs.
 Undertake capacity building activities to enhance the implementation of the NELDL.
 Strengthen regional supporting systems for specimen referral linkage and testing
services (laboratory referral networks, transportation and result delivery systems).
 Follow up on equipment management system at all healthcare facilities in the region
(installation, preventive and curative maintenance services)
 Closely monitor and evaluate the performance of NELDL implementation in the region;
develop and implement continuous improvement plans with regular reporting to the
EPHI.

Health Facilities

 Train laboratory managers and staff on the NELDL and testing algorithms.
 Audit current lab testing capacity (available HR, equipment and other infrastructure)
practices and commodity needs for the implementation of NELDL at the facility.
 Phase in implementation of NELDL starting with higher tier facilities.
 Allocated adequate resources for the implementation of the NELDL.
 Update lab testing menus, SOPs, quality systems to incorporate NELDL.
 Implement specimen referral system in line with the national and regional
arrangements.
 Provide regular reports on consumptions of reagents and consumable supplies in line
with the reporting requirements of the facility.
 Estimate annual test volumes and the required quantities of reagents and consumable
supplies and have them handy to share with all in need when requested.
 Periodically review the implementation of the NELDL at the facility including through
internal customer satisfaction assessments and share reports with all concerned.
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3.10.2 Monitoring and Evaluation Framework

Purpose of the M&E Framework

The purpose of the framework is to measure and monitor the effectiveness, efficiency and
impact of the implementation of the National Essential Laboratory Diagnostics List (NELDL).
As such, the framework presents a crucial tool for all involved in and responsible for the
implementation of the NELDL at various leadership and management levels of the national
health laboratory system. Furthermore, it is absolutely vital that all operational plans developed
for the implementation of the NELDL at health facilities across all tiers of the healthcare
service delivery system shall incorporate this fundamental M&E framework.

Information obtained from extensive review of the national health laboratory capacity building
strategies, and global experiences and benchmarks from the implementations of NELDLs have
served as critical inputs for the creation of this important M&E framework with clear key result
areas and related indicators.

Result Based Framework

Result-Based Monitoring and Evaluation Framework has been adopted to serve as a valuable
tool for assessing the progress and impact of the National Essential Laboratory Diagnostic List
implementation. Regularly tracking the selected indicators and adapting strategies based on
evaluation findings will help improve diagnostic services and, ultimately, enhance overall
healthcare outcomes.

And also, Results-Based Framework (RBF) is a strategic approach used to monitor and
evaluate the achievement of specific outcomes and impacts in a program or project
implementation. It's often structured around Key Result Areas (KRAs) to guide the assessment
of progress and effectiveness.

For this document, three key result areas are selected to provide a clear and systematic way
to measure progress and ensure that resources are effectively directed toward achieving the
desired outcomes and impacts.

Key Result Areas (KRAs) for Monitoring and Evaluating the Implementation of the
National Essential Laboratory Diagnostic List (ELDL):

I. Accessibility and Equitable Distribution of Essential Diagnostics:

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This KRA focuses on ensuring that essential diagnostic tests are accessible and evenly
distributed across different regions and healthcare facilities in Ethiopia. Key aspects to assess
include:

a. Geographical Coverage: Measure the presence and availability of essential diagnostic tests
in healthcare facilities across urban and rural areas, including remote geographic locations.

b. Health Facility Capacities: Evaluate the readiness and capacity of healthcare facilities to
provide essential diagnostic services, especially in underserved areas.

c. Affordability and Accessibility: Assess the affordability of essential diagnostics for patients,
particularly for vulnerable populations, and explore mechanisms to make them more accessible
and accessible.

II. Quality of Diagnostic Services:

This KRA aims to ensure that essential diagnostic services provided as part of the
implementation of the NELDL meet high-quality standards and produce accurate results. Key
aspects to assess include:

a. Laboratory Accreditation: Monitor the accreditation status of laboratories conducting

essential diagnostic tests, promoting adherence to international quality standards.

b. Proficiency Testing: Evaluate the proficiency of laboratory personnel and the accuracy of
diagnostic results through regular proficiency testing programs.

c. Quality Assurance and Quality Control Practices: Assess the implementation of quality
assurance and quality control measures to maintain the accuracy and reliability of diagnostic
tests.

III. Patient Outcomes and Improved Healthcare Management:

This KRA focuses on evaluating the impact of the implementation of the NELDL on patient
outcomes and overall healthcare management in Ethiopia. Key aspects to assess include:

a. Reduction of Diagnostic Delays: Evaluate whether the implementation of the NELDL

contributes to reducing delays in the diagnosis and initiation of treatment, leading to improved
health outcomes.

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c. Public Health Impact: Assess the contribution of the implementation of the NELDL to
performance improvement of public health indicators, particularly those designed to measure
the effectiveness of s disease surveillance, control, and prevention efforts.

These three key result areas cover crucial aspects of the ELDL implementation in Ethiopia,
including accessibility, quality, and impact on patient outcomes. To ensure effective
monitoring and evaluation, specific and measurable indicators should be defined for each KRA,
and data collection methods should be established to track progress over time. Additionally,
involving relevant stakeholders, including government agencies, healthcare providers, and
civil society organizations, will be essential for the successful implementation and continuous
improvement of ELDL in Ethiopia.

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 Community satisfaction and
Standardizing laboratory service

Imp
act

Accessibility and Equitable Patient Outcomes and

Outc
Distribution of Essential Quality of Diagnostic Services Improved Healthcare
ome
Diagnostics Management

 Health Facility Inventory

o  Diagnostic Efficiency
 GIS Mapping and Analysis: Accredited Laboratories
o Quality Control and Improvement Metrics
 Supply Chain Optimization  Redundant Test
Plan Assurance Protocol
o Reduced Turnaround Time Reduction Records
Out  Training Program  Patient Satisfaction
Documentation o Proficiency Testing
put Survey Results
Program Reports
 Financial Support  Healthcare Provider
Mechanisms: o Equipment Maintenance
Records Training
 Monitoring and Feedback Documentation
o External Quality
System
Assessment Participation  Data Analysis and
Reporting Documents

o Laboratory Accreditation
 Diagnostic Efficiency
 Manual distribution o Quality Control and
Analysis
 Renovation Assurance:
 Redundant Test Reduction
 Budgeting o Proficiency Testing
Acti  Patient Satisfaction
 Facility Assessment Programs
Surveys
vitie o
s  Supply Chain Strengthening Turnaround Time
 Healthcare Provider
 Mobile Diagnostic Units Reduction
Training and Guideline
 Training and Capacity o Equipment Maintenance
 Data Analysis and
Building and Calibration
Reporting
o Feedback Mechanisms

Figure 3: The Results Chain

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 Table 2: Indicator Matrix

No Key Indicators Description of indicators Disaggregation Data Source Means of

result Verification
Area
1. Percentage of medical facilities with Number of medical facilities Region, facility type, -National Inventory and
access to ELDL's essential with access to the ELDL's facility size , Health Procurement
Accessibility and Equitable Distribution of Essential Diagnostics

diagnostic tests. essential diagnostic tests/ Total # Facility Records, Health

of medical facilities *100 Inventory report, survey and
and Records. HIS
2. The proportion of health facilities Number of health facilities Region, facility Health Facility
providing ELDL-recommended tests providing ELDL- recommended type(pr/go), facility -Ministry of Surveys, record &
in each region. tests in each region / Total level Health report, Site Visits
number of facilities in the region reports on and Inspections
*100 diagnostic
3. Average Cost-to-patient for ELDL- Total Cost Incurred by Patients Type of test, location , services Billing and Financial
recommended testing for ELDL-Recommended Tests / facility type (priv/gov), availability. Records, Patient
Total Number of Patients Tested health care setting Surveys, Cost
(Hosps, HCs, Clinics) -Healthcare Analysis Tools,
cost data and reports
4. Travel time and distance to the Travel Time (in minutes) = Location, type of test, patient GIS, GPS data and
closest medical facility that performs Distance / Travel Speed mode of transport, age , surveys. mapping, facility
necessary diagnostic testing, sex, socioeconomic records, survey and
especially in rural and underserved NB: - Use GIS tools to calculate status -Geographic interview
locations. the distance (in kilometers or Information
miles) from the origin point to Systems
each destination point (GIS) data
-Determine which medical for travel
facility is the closest to the time
origin point based on either calculations.
travel time or travel distance,
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No Key Indicators Description of indicators Disaggregation Data Source Means of
result Verification
Area
depending on the specific -Health
analysis. facility
5. Number of necessary diagnostic Number of Necessary Type of Diagnostic, surveys Private Healthcare
procedures offered by public as Diagnostic Procedures Offered location, age gender, focusing on Provider Surveys,
opposed to private healthcare by Public Facilities - Number of equity and facility records ,
facilities. Necessary Diagnostic access. health report, patient
Procedures Offered by Private survey
Facilities -Referral
6. Proportion of health facilities able to Number of facilities that Region, facility, records and Reports, records,
perform necessary diagnostic tests perform necessary diagnostic availability of testes, health HIS, surveys
inside rather than referring to other tests inside rather than having to age , sex , facility
hospitals send patients to other hospitals/ socioeconomic status reports.
Total number of facilities
perform necessary diagnostic -Supply
tests *100 chain
7. Percentage of health facilities with a Number of health facilities with Region, type of test, management Supply chain records
functional supply chain for essential a functional supply chain for type of facility records and , surveys and
diagnostic tests essential diagnostic tests/ Total # inventory assessment
of facilities perform necessary report
diagnostic tests * 100
8. Percentage of accredited laboratories Number of accredited Region , test type, -Laboratory Accreditation report,
Diagnostic Services.

performing essential diagnostic tests, laboratories performing essential facilities accreditation health report,
Accuracy of
Quality and

diagnostic tests/ Total # of records and websites, surveys

accredited laboratories *100 reports.
9. Proficiency testing score of Number of Correctly Handled Region, type of test, -Incident Proficiency Testing
laboratory personnel involved in Tests / Total Number of Tests in laboratory level , time reports and Program Records,
conducting ELDL-recommended Proficiency Testing x 100 error tracking reports
tests. systems.
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No Key Indicators Description of indicators Disaggregation Data Source Means of
result Verification
Area
10. Average turnaround time for Total Turnaround Time for Time , region , test -Laboratory Facility records,
essential diagnostic tests, essential diagnostic tests type, facility level quality LIS, health reports,
conducted during a specific control and facility and
period / Total Number of all assurance laboratory
essential diagnostic tests documentatio assessment
conducted during the same n.
period -Laboratory
11. Proportion of sample contamination Number of Erroneous or Type of Erroneous records and Laboratory Quality
or pre-analytical errors for essential Contaminated Samples / Total Diagnostic Tests, time, workflow Control and
diagnostic tests. Number of Samples Processed * region, facility level data. Assurance Records,
100 -Proficiency Surveys and Incident
testing Reporting
12. Number of laboratory personal Total Count of Trained Region , time , Type of program Training report
trained in proper sample collection Laboratory Personnel ELDL-Recommended records. &records,
and handling techniques for ELDL- Test, laboratory level -Laboratory assessment
recommended tests. error logs
13. Percentage of essential diagnostic Number of essential diagnostic Type of test, region , and incident LIS, accreditation
tests conducted in accredited tests conducted in accredited time , laboratory level reports. report, assessment
laboratories laboratories/ Total number of -Training
accredited laboratories*100 records and
14. Number of laboratory personnel Total Count of Trained type of Public Health healthcare Training records
trained in handling specific Laboratory Personnel Emergency, time, provider &reports,
diagnostic tests required during region , Laboratory surveys. assessment
different types of public health Personnel Roles
emergencies.

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No Key Indicators Description of indicators Disaggregation Data Source Means of
result Verification
Area
15. Rate of change in the number of (Number of Unnecessary Tests Diagnostic tests list, Healthcare Reports,
unnecessary or redundant diagnostic Before ELDL - Number of region, facilities level, cost data and assessments, cost
Patient Outcomes and Improved Healthcare

tests conducted due to ELDL Unnecessary Tests After ELDL) time period utilization analysis ,
implementation. / Number of Unnecessary Tests statistics Comparative
Before ELDL *100 Analysis

16. Percentage of healthcare providers Number of Healthcare Region, Facilities level Training and
Management

accessing and utilizing clinical Providers Accessing and , Type of healthcare Education Records,
guidelines based on the ELDL Utilizing Guidelines / Total providers, Type of facility report,
recommendations. Number of Healthcare Clinical Guideline Healthcare Provider
Providers* 100 Surveys, clinical
guideline records
17 Utilization rate of ELDL- Number of ELDL- Type of emergency, Emergency
recommended diagnostics for disease Recommended Diagnostic Tests region , time , facility Response Plans,
surveillance during and after public Conducted for Disease level surveillance report,
health emergencies. Surveillance / Total Number of facility report
Diagnostic Tests Required for
Disease Surveillance* 100

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Monitoring and Evaluation Plan

Monitoring Plan

It is important to be explicit about the availability, effectiveness, and quality monitoring plan
for the essential diagnostic list and strategy. The overall national monitoring cycle should be
linked and consistent with the NELDL's monitoring plan. Making the utilization of the NELDL
an integral element of the facilities' performance audit procedures would make it easier to track
and evaluate each region's performance across the nation on a regular basis. The KRAs and
KPIs listed in this document should be the main topics of the monitoring plan. It should be
emphasized that relevant institutions must set goals for these KPIs during planning, and the
KPIs are then monitored in relation to these goals. There is a requirement to establish baseline
values for each KPI that act as a reference for continuous monitoring of intervention.

Since the NELDL strategy is being implemented as part of institutional initiatives, it should be
reviewed annually by the institution that is responsible for the coordination of implementation
activities. On the other hand, based on the advancements made in comparison to the goals and
by conducting extensive health facility assessments across the nation, the overall
implementation of the NELDL should be annually evaluated at the national level with the
involvement of all stakeholders and partners. Additionally, regular consultative forums should
be set up where performances can be reviewed, gaps identified and corrective action plans
developed for continuous process improvement and performance.

Evaluation Plan

Implementation of the strategy should be monitored on a regular basis to ensure that all
institutions and facilities are following it faithfully. Process evaluation can be carried out so
that it gives the chance to spot problems, look at implementation choices, and then take
appropriate corrective actions.

Revising the NELDL strategy should be informed by a thorough evaluation. To evaluate the
effects of the implementation of the NELDL on healthcare outcomes, service quality, and cost-
effectiveness, it is important to conduct frequent reviews and evaluations (e.g., annually or
every two years) of the healthcare service delivery system.

Evaluation activities may include qualitative assessments such as Service Availability and
Readiness Assessment (SARA) or Service Provision Assessment (SPA), case studies, and cost-

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benefit analyses. These evaluations should focus on processes, outcomes and impacts of the
strategy. An extensive analysis should guide the revision of the NELDL strategy. The method,
results, effectiveness and impacts of the approach should be the main subjects of these
evaluations.

Data Sources, Reporting and Management

In the context of monitoring and evaluation (M&E), a data source refers to the origin or location
from where data is collected, generated, or obtained for the purpose of assessing and measuring
the performance, progress, and impacts of a program, project, policy, or initiative. Data sources
provide the raw information and evidence needed to conduct M&E activities.

Data Sources for the National Essential Laboratory Diagnostic List (NELDL) are:

 Health Facility Records: Data from healthcare facilities regarding the availability of
diagnostic tests, equipment, and trained personnel. This includes test menu for
essential diagnostic tests.
 Patient Records: Information on patient diagnoses, treatments, and outcomes, which
can be anonymous and aggregated for analysis.
 Laboratory Records: Data from laboratories conducting diagnostic tests, including test
results, error reports, proficiency testing performance results, and quality control
records.
 Laboratory Quality Management System (LQMS) implementation and Accreditation:
Laboratory Quality Manual, documented implementation processes and practices, and
certificate of accreditation.
 Training Records: Records of healthcare provider training programs (in-service
laboratory trainings, Continuous Professional Development/CPD and other accredited
trainings), including assessments and certifications.
 Patient Satisfaction Surveys: Feedback and responses from patient satisfaction
surveys regarding the quality of diagnostic services provided as part of the
implementation of the NELDL.
 Geographic Information Systems (GIS): Geographic data used to map the distribution
and referral networks of healthcare facilities, accessibility, and gaps in diagnostic
services including existing systems for specimen transportation and result delivery.

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  Supply Chain Management Records: Data related to the procurement, distribution,
and availability of diagnostic tests and equipment.
 External Quality Assessment Programs: Data from external quality assessment
programs assessing the accuracy and reliability of diagnostic results.

National Reference
Laboratories
EPHI/MOH Federal Hospitals including
those of the Uniformed
Forces

Regional Public Health

Regional
Institutes/Regional
Reference Laboratories
Infor
mati Feed
on back

Zonal Referral hospitals

laboratories

Woreda Health center laboratories

Figure 4: Information/ Data Exchange

3.11 Revision Requirement of the NELDL

Review Frequency

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  The NELDL should be reviewed regularly, preferably every 2-3 years, to ensure it
remains up-to-date. More frequent reviews may be warranted when new tests or
technologies emerge.

Triggers for Revision

 Changes in disease burden, epidemiology, or public health priorities.

 Introduction of new diagnostics or global guidance.
 Changes in clinical recommendations for diagnosis and management of diseases.
 Significant shifts in population demographics or health system structure.
 Issues with availability or costs of listed tests.
 Feedback from clinical healthcare providers and laboratories indicating need for
revision.

Review Process

 A multidisciplinary committee should be involved, including lab experts, clinicians,

public health professionals.
 Review existing lists, disease data, utilization data, budgets, and global
recommendations.
 Draft changes through a consultative process involving key stakeholders and partners.
 Revise lists based on feedback and finalize with approval from Ministry of Health.

Dissemination

 Communicate and distribute the updated NELDL widely to all laboratories, facilities,
and health professionals.
 Conduct trainings or orientation workshops as found necessary to support transition to
the updated NELDL.

By institutionalizing a regular review and responsive revision process that involves the
participation and contributions of all stakeholders and partners, the NELDL can remain a
highly relevant, up-to-date resource material for continuous optimization and improvement of
laboratory diagnostic services for patient care and public health needs.

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Annex 1. Contributors

1. The National Essential Laboratory Diagnostic List Preparation Technical Working

Group Members

No Name Organization
1 Desalegn Addise EPHI
2 Lulit Hailu EPHI
3 Dr. Tilahun Ferede EPHI
4 Asmare Mekonnen EPHI
5 Kumera Terfa EPHI
6 Daniel Demissie EPHI
7 Dr. Mistire Woldie AAU
8 Zelalem Messele CHAI
9 Mulat Wolde CU-ICAP in Ethiopia
10 Teferi Mekonnen ASLM
11 Kassahun Endalew EPSS
12 Betelhem Getu EPHI
13 Foziya Seid EPHLA
13 Negash Nurahmed EPHI
14 Tiringo Mengaw EFDA
15 Estifanos Tsige EPHI
16 Hiwot Abebe EPHI
17 Abebaw Kebede Africa CDC
18 Abrham Keraleme EPHI
19 Daniel Woldesenbet CU-ICAP in Ethiopia
20 Mihiret Tatek EPHI
21 Achamyeleh Mulugeta CDC-Ethiopia
22 Mekonnen Tadesse CU-ICAP in Ethiopia
23 Dr. Eyob Abera EPHI
24 Gonfa Ayana EPHI
25 Hellen Kassa FIND
26 Daniel Melese EPHI

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2. List of Consultative workshop participants

No Name Organization
1 Abdulfetah Kedir EPHI
2 Adino Desale EPHI
3 Andargachew Gashu EPHI
4 Awad Mohammed EPHI
5 Awoke Getahun Gambela Regional Reference Laboratory
6 Ayinalem Alemu EPHI
7 Bereketeab Berhanu EPHI
8 Dagim Kemiso B/Gumuz Regional Reference Laboratory
9 Demelash Mekashaw Afar PHI
10 Dr. Kassaye Demeke University of Gondar CS Hospital
11 Fikru Fajiyo South West Ethiopia PHI
12 Getachew Sori Oromia Regional Health Bureau
13 Girma Wondimu SNNPRPHL
14 Gizachew Kedida EMLA
15 Henok Tadesse EPHI
16 Hiwot Hailu UKHSA
17 Konjit Bitew Sidama PHI
18 Mahdi Ismael Somali Regional Reference Laboratory
19 Merihun Dawit South Ethiopia PHI
20 Meshesha Tsigie EPHI
21 Muzit Berhane Tigray HRI
22 Tadesse Gerenfes EPHI
23 Tesfa Demilie APHI Bahrdar
24 Ziad Amin Harari Regional Reference Laboratory

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 Ethiopian Public Health Institute (EPHI)

Ethiopian Public Health Institute

Addis Ababa, Ethiopia

Website: http://www.ephi.gov.et

Tel:+251-112133499
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Fax: 0112765340

P.O. Box: 1242 /5654