© Hepatitis C Online

PDF created January 19, 2024, 11:33 pm

Hepatitis C Diagnostic Testing

This is a PDF version of the following document:

Module 1: Screening and Diagnosis of Hepatitis C Infection
Lesson 3: Hepatitis C Diagnostic Testing

You can always find the most up-to-date version of this document at
https://www.hepatitisC.uw.edu/go/screening-diagnosis/diagnostic-testing/core-concept/all.

HCV Diagnostic Tests

Serologic Antibody Assays

Initial testing for the diagnosis of hepatitis C infection uses serologic assays that detect human antibodies
generated as a response to hepatitis C virus (HCV) infection.[1,2,3] A positive HCV antibody test indicates one
of the following three scenarios: (1) active infection, (2) past HCV infection that has resolved or been cured,
or (3) a false-positive test.[1,4] None of these anti-HCV antibody tests can differentiate whether the infection
is new (acute), chronic, or no longer present.

Enzyme Immunoassay (EIA): The third-generation HCV EIA detects antibodies that bind to
recombinant antigens derived from four HCV regions: core, nonstructural 3, nonstructural 4, and
nonstructural 5 (Figure 1).[6,7] The EIA test is reported as positive or negative based on an
absorbance signal compared with a cutoff value.
Sensitivity of EIA and False-Negative Results: The third-generation HCV EIA has a sensitivity of
approximately 98%.[8,9,10] Circumstances associated with a false-negative EIA include
patients with acute HCV infection, persons with major immune compromising
conditions (advanced HIV infection or organ transplantation recipients), and persons with
chronic renal failure on long-term hemodialysis.
Specificity of EIA and False-Positive Results: The third-generation HCV EIA has a reported
specificity greater than 99%; false-positive tests can occur with increased gamma globulin
production, with autoimmune diseases, and following immunizations.[8] In addition, a false-
positive test is more likely when performing widespread testing in populations that have a very
low HCV prevalence.
Chemiluminescence Immunoassay (CIA): The CIA test is an antibody test similar to the EIA but is
used less frequently than the EIA test. For the diagnosis of HCV, the CIA has similar sensitivity and
specificity as the third-generation EIA.[1,11]
Point-of-Care Rapid Immunoassays: The OraQuick HCV Rapid Antibody Test was approved by the
U.S. Food and Drug Administration (FDA) in 2010 as a point-of-care test for use with whole blood
samples obtained by either venipuncture or fingerstick. This OraQuick Rapid Antibody Test can be
used as an alternative to the third-generation EIA for initial HCV antibody testing.[12,13,14,15] The
OraQuick test is read 20 to 40 minutes after the test device is inserted into the buffer, and the result
is either reactive or nonreactive (Figure 2).[12,13] In 2011, the FDA granted a Clinical Laboratory
Improvement Amendments (CLIA) waiver for the OraQuick HCV Rapid Antibody Test. Additional point-
of-care rapid HCV antibody tests have been developed but are not approved for use in the United
States.[16,17]

Page 1/20
Molecular HCV RNA Tests

Molecular diagnostic tests for hepatitis C specifically detect HCV RNA and the process is commonly referred to
as a Nucleic Acid Test (NAT) or Nucleic Acid Amplification Test (NAAT).[18] The HCV NAT becomes positive
approximately 1 to 2 weeks after initial HCV infection.[19] The NAT test has become the gold standard
supplemental test for patients who have a positive HCV EIA screening test.[2,18] The NAT can determine
whether a patient with a positive HCV antibody test has current (active) or resolved HCV infection.[2,6] In
addition, the NAT can be used in combination with other laboratory studies, such as prior antibody test results
or hepatic aminotransferase levels, to suggest the possibility of acute HCV infection.[19] The results for the
commercially available quantitative HCV RNA assays, which were previously reported as copies/mL, are
now given in International Units per milliliter (IUs/mL).[6]

Qualitative HCV RNA: The qualitative HCV RNA tests provide a yes or no answer to whether
detectable HCV RNA is present in the patient's blood sample.[20] The qualitative HCV RNA assays are
FDA-approved for HCV diagnostic purposes. These tests, however, do not provide a quantitative level
of HCV and are not used for baseline HCV RNA levels or for monitoring response to therapy.[20] For
most qualitative HCV RNA assays, the lower limit of detection is 10-15 IU/mL.[20]
Quantitative HCV RNA: The quantitative HCV RNA tests detect and quantify the number of HCV
copies in the patient's blood sample, reported as IU/mL. Clinically, these tests are used for
diagnosing HCV and monitoring response to therapy. Quantitative HCV RNA tests used for diagnosis
and monitoring should have a lower limit of detection of 25 IU/mL or less.[6,21]

Immunoassays for HCV Core Antigen

As an HCV diagnostic marker, HCV core antigen has been studied, either alone or as an HCV antibody-HCV
antigen combination assay.[22,23] Some experts have proposed the use of an HCV core antigen test as a less
expensive option than HCV RNA testing, but there are no HCV antigen assays (or HCV antigen-antibody
combination assays) that are FDA-approved for use in the United States at this time.[24,25]

Page 2/20
HCV Testing Sequence
Recommended Testing Sequence

In May 2013, the Centers for Disease Control and Prevention (CDC) published a recommended testing
sequence for diagnosing current (active) hepatitis C infection (Figure 3).[2] This 2013 HCV diagnostic testing
sequence recommended by the CDC is not intended for the diagnosis of acute HCV infection.[2] The 2013
recommended testing sequence consists of initial HCV antibody testing (using either a rapid or laboratory-
conducted assay), followed by HCV RNA testing for all persons with a positive HCV antibody test.[2] Using this
algorithm, the following test results are possible.[2]

Negative HCV Antibody Test: Persons who have a negative screening HCV antibody test are
considered not infected with HCV and do not need further diagnostic evaluation, unless they have a
known risk factor for a false-negative test, such as suspected acute HCV infection, chronic
hemodialysis, or an immunocompromising condition, such as HIV infection with a low CD4 cell count.
Positive HCV Antibody and Positive HCV RNA: Individuals who have a positive HCV antibody test
and a positive HCV RNA are considered to have current (active) HCV infection.
Positive HCV Antibody and Negative HCV RNA: Individuals with a positive HCV antibody test and
a negative HCV RNA assay have evidence of prior exposure to HCV but do not have current HCV
infection. This testing profile occurs in the setting of spontaneous clearance of HCV or successful
treatment.

Reflexive HCV RNA Testing with Positive Initial HCV EIA

The CDC encourages setting up a procedure whereby samples that test positive with a laboratory-conducted
HCV antibody assay will then undergo reflexive HCV RNA testing using the same patient's blood sample.[26]
Many laboratories now offer reflexive HCV RNA testing on HCV antibody-positive samples.[2] The reflexive
testing approach is more efficient than other approaches for follow-up HCV RNA testing that include (1)
collecting two separate venipuncture samples at the initial blood draw (with the option of ordering the HCV
RNA test if the antibody test is positive) or (2) having the patient return for another venipuncture after
receiving a positive antibody test result.[2] From a practical standpoint, it is clearly preferable to have the
laboratory reflexively perform the HCV RNA testing for positive HCV EIA tests utilizing the same blood sample.

Page 3/20
Interpreting and Communicating Test Results
Interpretation of HCV Test Results and Recommended Action

Prior to discussing the HCV test results with the individual who has undergone testing, it is important to
interpret the test results and have a plan for communicating the test results and your recommended further
action (Table 1).[2] Individuals who engage in activities, such as injection drug use, that place them at higher
risk of acquiring HCV should undergo regular screening for HCV infection.

Negative HCV Antibody

Individuals with a negative HCV antibody test result should be informed they are not infected with HCV, as
long as they have not had a potential exposure to HCV in the prior 6 months.[2] If they have not had a
potential exposure to HCV in the prior 6 months, they do not need further follow-up HCV testing, unless they
have an exposure to HCV in the future or engage in activities that place them at ongoing risk for HCV
acquisition.[2]

Negative HCV Antibody and Positive HCV RNA

Individuals who have a negative HCV antibody test in the setting of a recent exposure to HCV may possibly
have acute or very early HCV infection. In this situation, an HCV RNA test should be ordered and, if positive,
would indicate acute or very early HCV infection. Given the potential fluctuations of HCV RNA levels early
after infection, a follow-up HCV RNA level is indicated for individuals with a recent (within 6 months) exposure
to HCV if the HCV RNA is negative.

Positive HCV Antibody and Negative HCV RNA

Individuals with a positive HCV antibody test and a negative HCV RNA should be informed they do not have
evidence of current hepatitis C infection.[2] It should be explained to the patient that most likely they were
previously infected with HCV, but cleared the infection on their own. In addition, persons who have been
successfully treated for HCV will also have a positive HCV antibody and negative HCV RNA. In both of these
situations, they do not need further follow-up HCV testing if they do not subsequently have exposure to HCV.
If, however, they have ongoing or future risk for reacquiring HCV, future testing for active HCV infection
should be performed with a repeat HCV RNA, as the HCV antibody test will remain reactive for life. Individuals
who have a positive HCV antibody and negative HCV RNA should receive counseling that prior infection does
not make them immune to reinfection with HCV.[27,28,29]

Positive HCV Antibody and Positive HCV RNA

Individuals with a positive HCV antibody and positive HCV RNA should be told they have active hepatitis C
infection, and they should clearly understand they need medical follow-up evaluation and treatment for
HCV.[2] A single positive HCV RNA value indicates infection but must be interpreted in the context of clinical
history to determine whether the individual has acute or chronic infection. For persons with a positive HCV
antibody and positive HCV RNA, the CDC has generated counseling messages that focus on four areas: (1)
contacting a health care provider for further evaluation and management of their HCV infection, (2)
protecting their liver from further harm, (3) addressing weight management in overweight and obese persons,
and (4) minimizing transmission of their HCV to others (Table 2).[30] In addition, the CDC recommends
performing alcohol screening and brief intervention, which consists of screening for excessive alcohol
consumption, brief counseling for individuals who screen positive, and referral to a specialized alcohol
treatment program for individuals with possible alcohol dependence.[30]

Page 4/20
Linkage to Care
Recommendations Regarding Linkage to Care

All persons identified with active hepatitis C infection (positive HCV RNA) should be linked to a medical
provider who can provide competent and comprehensive management of HCV.[21,30] Available data suggest
that in the current era, nonspecialists can effectively manage HCV, especially with backup and consultation
for more complicated issues.[31,32,33,34,35] The management of patients with decompensated cirrhosis
should always involve a hepatologist. In addition, persons with HCV who have prior treatment experience,
hepatitis B coinfection, hepatocellular carcinoma, prior liver transplantation, or extrahepatic complications of
HCV infection will likely require referral to a specialist. An individual with a positive HCV antibody test but
negative HCV RNA level does not require a referral for further evaluation and management of HCV infection.

Recommended Laboratory Evaluation Prior to Referral

All persons referred for further evaluation and management of HCV infection should have a confirmed positive
HCV RNA level, preferably a quantitative HCV RNA level (viral load) and not a qualitative HCV RNA level.[21] It
is ideal, but not imperative, that the clinician who makes the diagnosis of HCV infection can perform some
preliminary tests to provide advanced information in anticipation of the initial referral visit. These initial
preliminary tests include tests of synthetic liver function (platelet count, total bilirubin, albumin, prothrombin
time [PT]), hepatic inflammation (alanine aminotransferase [ALT] and aspartate aminotransferase [AST]), and
assays to detect relevant coinfection—HIV antibody, hepatitis A antibody, hepatitis B surface antigen (HBsAg),
antibody to hepatitis B surface antigen (anti-HBs), and total antibody to hepatitis B core antigen
(anti-HBc).[21] For primary care medical providers who are taking on a more comprehensive role for the
initial evaluation and management, see Module 2, Lesson 1 for a detailed discussion in the Core Concept
Initial Evaluation of Persons with Chronic Hepatitis C.

Gap in Linkage to Care

Unfortunately, many individuals diagnosed with HCV infection (positive HCV RNA) do not get linked to
appropriate care for their HCV infection.[36] Multiple reasons for gaps in linkage to care have been cited,
including failure of the medical provider to make the referral, lack of medical insurance, substance use,
mental health disorders, and housing instability that interfere with making or keeping referral appointments.
Linkage to care rates have been lower among racial and ethnic minorities. Failure to link to care negatively
impacts health outcomes in persons living with HCV infection.[37] With highly effective HCV treatment now
available for all HCV genotypes, referral for evaluation and management of HCV has taken on even greater
importance.

Strategies for Improving Linkage to Care

Attempts at the public health level to implement an HCV testing and linkage-to-care program have shown
that additional funds can be used to leverage existing programs and provider networks.[38,39] The CDC and
other organizations are actively working to explore strategies, such as the Hepatitis Testing and Linkage to
Care (HepTLC) initiative, to enhance linkage to care for persons with HCV infection, including through
simplification and decentralization of treatment.[40,41] Some individuals face barriers that prevent them
from linking to care and receiving HCV treatment. For more information on this topic, see Module 4, Lesson 3:
Addressing Structural Barriers to HCV Treatment.

Page 5/20
Summary Points
Diagnostic tests for hepatitis C include serologic assays that measure human antibodies generated in
response to HCV infection and molecular virologic assays that directly detect HCV RNA.
The third-generation HCV EIA test is the most frequently used antibody test to initially screen for HCV
infection. The test has high sensitivity and specificity, but does not distinguish between current and
resolved hepatitis C infection.
The OraQuick HCV Rapid Antibody Test is available as a point-of-care rapid test and can be used for
initial HCV antibody screening.
Quantitative HCV RNA assays are the preferred supplemental test for persons who have a positive
screening HCV antibody test. Testing positive for HCV RNA indicates current (active) HCV infection.
Qualitative HCV RNA assays can be used for diagnosis but do not offer any advantage over the
quantitative assay and should not be used for monitoring response to treatment.
The 2013 CDC-recommended testing sequence for identifying current HCV infection consists of initial
HCV antibody testing (either rapid or laboratory-conducted assay) followed by an HCV RNA assay for
all positive antibody tests.
All HCV testing results should be communicated to the person undergoing testing; individuals who
have a positive HCV RNA assay should understand they have current (active) hepatitis C infection.
Individuals who have a positive HCV RNA assay and newly diagnosed hepatitis C should receive
preliminary counseling about protecting their liver from further harm, including cessation of alcohol
use, strategies for weight loss if they are overweight, and how to minimize their risk of transmitting
HCV to others.
Individuals with newly diagnosed hepatitis C infection should be linked to clinical care for further liver
disease evaluation and HCV treatment.

Page 6/20
Citations
1. Alter MJ, Kuhnert WL, Finelli L. Guidelines for laboratory testing and result reporting of antibody to
hepatitis C virus. Centers for Disease Control and Prevention. MMWR Recomm Rep. 2003;52:1-13, 15.
[PubMed Abstract] -

2. Centers for Disease Control and Prevention (CDC). Testing for HCV infection: an update of guidance for
clinicians and laboratorians. MMWR Morb Mortal Wkly Rep. 2013;62:362-5.
[PubMed Abstract] -

3. Majid AM, Gretch DR. Current and future hepatitis C virus diagnostic testing: problems and
advancements. Microbes Infect. 2002;4:1227-36.
[PubMed Abstract] -

4. Cloherty G, Talal A, Coller K, et al. Role of Serologic and Molecular Diagnostic Assays in Identification
and Management of Hepatitis C Virus Infection. J Clin Microbiol. 2016;54:265-73.
[PubMed Abstract] -

5. Kamili S, Drobeniuc J, Araujo AC, Hayden TM. Laboratory diagnostics for hepatitis C virus infection. Clin
Infect Dis. 2012;55 Suppl 1:S43-8.
[PubMed Abstract] -

6. Richter SS. Laboratory assays for diagnosis and management of hepatitis C virus infection. J Clin
Microbiol. 2002;40:4407-12.
[PubMed Abstract] -

7. Colin C, Lanoir D, Touzet S, Meyaud-Kraemer L, Bailly F, Trepo C. Sensitivity and specificity of third-
generation hepatitis C virus antibody detection assays: an analysis of the literature. J Viral Hepat.
2001;8:87-95.
[PubMed Abstract] -

8. Abdel-Hamid M, El-Daly M, El-Kafrawy S, Mikhail N, Strickland GT, Fix AD. Comparison of second- and
third-generation enzyme immunoassays for detecting antibodies to hepatitis C virus. J Clin Microbiol.
2002;40:1656-9.
[PubMed Abstract] -

9. Kao JH, Lai MY, Hwang YT, et al. Chronic hepatitis C without anti-hepatitis C antibodies by second-
generation assay. A clinicopathologic study and demonstration of the usefulness of a third-generation
assay. Dig Dis Sci. 1996;41:161-5.
[PubMed Abstract] -

10. Dufour DR, Talastas M, Fernandez MD, Harris B. Chemiluminescence assay improves specificity of
hepatitis C antibody detection. Clin Chem. 2003;49:940-4.
[PubMed Abstract] -

11. Lee SR, Kardos KW, Schiff E, et al. Evaluation of a new, rapid test for detecting HCV infection, suitable
for use with blood or oral fluid. J Virol Methods. 2011;172:27-31.
[PubMed Abstract] -

12. Lee SR, Yearwood GD, Guillon GB, et al. Evaluation of a rapid, point-of-care test device for the
diagnosis of hepatitis C infection. J Clin Virol. 2010;48:15-7.
[PubMed Abstract] -

Page 7/20
13. Smith BD, Drobeniuc J, Jewett A, et al. Evaluation of three rapid screening assays for detection of
antibodies to hepatitis C virus. J Infect Dis. 2011;204:825-31.
[PubMed Abstract] -

14. Smith BD, Teshale E, Jewett A, et al. Performance of premarket rapid hepatitis C virus antibody assays
in 4 national human immunodeficiency virus behavioral surveillance system sites. Clin Infect Dis.
2011;53:780-6.
[PubMed Abstract] -

15. Jewett A, Smith BD, Garfein RS, Cuevas-Mota J, Teshale EH, Weinbaum CM. Field-based performance of
three pre-market rapid hepatitis C virus antibody assays in STAHR (Study to Assess Hepatitis C Risk)
among young adults who inject drugs in San Diego, CA. J Clin Virol. 2012;54:213-7.
[PubMed Abstract] -

16. Shivkumar S, Peeling R, Jafari Y, Joseph L, Pant Pai N. Accuracy of rapid and point-of-care screening
tests for hepatitis C: a systematic review and meta-analysis. Ann Intern Med. 2012;157:558-66.
[PubMed Abstract] -

17. Scott JD, Gretch DR. Molecular diagnostics of hepatitis C virus infection: a systematic review. JAMA.
2007;297:724-32.
[PubMed Abstract] -

18. Glynn SA, Wright DJ, Kleinman SH, et al. Dynamics of viremia in early hepatitis C virus infection.
Transfusion. 2005;45:994-1002.
[PubMed Abstract] -

19. Peeling RW, Boeras DI, Marinucci F, Easterbrook P. The future of viral hepatitis testing: innovations in
testing technologies and approaches. BMC Infect Dis. 2017;17:699.
[PubMed Abstract] -

20. AASLD-IDSA. HCV Guidance: Recommendations for testing, management, and treating hepatitis C.
HCV testing and linkage to care.
[AASLD-IDSA Hepatitis C Guidance] -

21. Hullegie SJ, GeurtsvanKessel CH, van der Eijk AA, Ramakers C, Rijnders BJA. HCV antigen instead of
RNA testing to diagnose acute HCV in patients treated in the Dutch Acute HCV in HIV Study. J Int AIDS
Soc. 2017;20:21621.
[PubMed Abstract] -

22. Laperche S, Nübling CM, Stramer SL, et al. Sensitivity of hepatitis C virus core antigen and antibody
combination assays in a global panel of window period samples. Transfusion. 2015;55:2489-98.
[PubMed Abstract] -

23. Freiman JM, Tran TM, Schumacher SG, et al. Hepatitis C Core Antigen Testing for Diagnosis of Hepatitis
C Virus Infection: A Systematic Review and Meta-analysis. Ann Intern Med. 2016;165:345-55.
[PubMed Abstract] -

24. Khan H, Hill A, Main J, Brown A, Cooke G. Can Hepatitis C Virus Antigen Testing Replace Ribonucleic
Acid Polymearse Chain Reaction Analysis for Detecting Hepatitis C Virus? A Systematic Review. Open
Forum Infect Dis. 2017;4:ofw252.
[PubMed Abstract] -

25. Schillie S, Wester C, Osborne M, Wesolowski L, Ryerson AB. CDC Recommendations for Hepatitis C
Screening Among Adults - United States, 2020. MMWR Recomm Rep. 2020;69:1-17.

Page 8/20
 [PubMed Abstract] -

26. Bate JP, Colman AJ, Frost PJ, Shaw DR, Harley HA. High prevalence of late relapse and reinfection in
prisoners treated for chronic hepatitis C. J Gastroenterol Hepatol. 2010;25:1276-80.
[PubMed Abstract] -

27. Falade-Nwulia O, Sulkowski MS, Merkow A, Latkin C, Mehta SH. Understanding and addressing
hepatitis C reinfection in the oral direct-acting antiviral era. J Viral Hepat. 2018;25:220-227.
[PubMed Abstract] -

28. Sarrazin C, Isakov V, Svarovskaia ES, et al. Late Relapse Versus Hepatitis C Virus Reinfection in
Patients With Sustained Virologic Response After Sofosbuvir-Based Therapies. Clin Infect Dis.
2017;64:44-52.
[PubMed Abstract] -

29. Smith BD, Morgan RL, Beckett GA, et al. Recommendations for the identification of chronic hepatitis C
virus infection among persons born during 1945-1965. MMWR Recomm Rep. 2012;61:1-32.
[PubMed Abstract] -

30. Guss D, Sherigar J, Rosen P, Mohanty SR. Diagnosis and Management of Hepatitis C Infection in
Primary Care Settings. J Gen Intern Med. 2018;33:551-7.
[PubMed Abstract] -

31. Arora S, Thornton K, Murata G, et al. Outcomes of treatment for hepatitis C virus infection by primary
care providers. N Engl J Med. 2011;364:2199-207.
[PubMed Abstract] -

32. Kattakuzhy S, Gross C, Emmanuel B, et al. Expansion of Treatment for Hepatitis C Virus Infection by
Task Shifting to Community-Based Nonspecialist Providers: A Nonrandomized Clinical Trial. Ann Intern
Med. 2017;167:311-318.
[PubMed Abstract] -

33. Ngo BV, James JR, Blalock KL, Jackson SL, Chew LD, Tsui JI. Hepatitis C treatment outcomes among
patients treated in co-located primary care and addiction treatment settings. J Subst Abuse Treat.
2021;131:108438.
[PubMed Abstract] -

34. Oru E, Trickey A, Shirali R, Kanters S, Easterbrook P. Decentralisation, integration, and task-shifting in
hepatitis C virus infection testing and treatment: a global systematic review and meta-analysis. Lancet
Glob Health. 2021;9:e431-e445.
[PubMed Abstract] -

35. Holmberg SD, Spradling PR, Moorman AC, Denniston MM. Hepatitis C in the United States. N Engl J
Med. 2013;368:1859-61.
[PubMed Abstract] -

36. Tohme RA, Xing J, Liao Y, Holmberg SD. Hepatitis C testing, infection, and linkage to care among racial
and ethnic minorities in the United States, 2009-2010. Am J Public Health. 2013;103:112-9.
[PubMed Abstract] -

37. Seña AC, Willis SJ, Hilton A, et al. Efforts at the Frontlines: Implementing a Hepatitis C Testing and
Linkage-to-Care Program at the Local Public Health Level. Public Health Rep. 2016;131 Suppl 2:57-64.
[PubMed Abstract] -

Page 9/20
 38. Rhea S, Seña AC, Hilton A, Hurt CB, Wohl D, Fleischauer A. Integrated Hepatitis C Testing and Linkage
to Care at a Local Health Department Sexually Transmitted Disease Clinic: Determining Essential
Resources and Evaluating Outcomes. Sex Transm Dis. 2018;45:229-232.
[PubMed Abstract] -

39. Ramirez G, Cabral R, Patterson M, et al. Early Identification and Linkage to Care for People with
Chronic HBV and HCV Infection: The HepTLC Initiative. Public Health Rep. 2016;131 Suppl 2:5-11.
[PubMed Abstract] -

40. World Health Organization. Updated recommendations on simplified service delivery and diagnostics
for hepatitis C infection. Policy Brief. Geneva: World Health Organization; 2022.
[WHO] -

References
AASLD-IDSA. HCV Guidance: Recommendations for testing, management, and treating hepatitis C.
[AASLD-IDSA Hepatitis C Guidance] -

Chevaliez S, Rodriguez C, Pawlotsky JM. New virologic tools for management of chronic hepatitis B and
C. Gastroenterology. 2012;142:1303-1313.e1.
[PubMed Abstract] -

Chevaliez S, Soulier A, Poiteau L, Bouvier-Alias M, Pawlotsky JM. Clinical utility of hepatitis C virus core
antigen quantification in patients with chronic hepatitis C. J Clin Virol. 2014;61:145-8.
[PubMed Abstract] -

Dawson GJ. The potential role of HCV core antigen testing in diagnosing HCV infection. Antivir Ther.
2012;17:1431-5.
[PubMed Abstract] -

Manns MP, Buti M, Gane E, et al. Hepatitis C virus infection. Nat Rev Dis Primers. 2017;3:17006.
[PubMed Abstract] -

Martinello M, Hajarizadeh B, Grebely J, Dore GJ, Matthews GV. HCV Cure and Reinfection Among
People With HIV/HCV Coinfection and People Who Inject Drugs. Curr HIV/AIDS Rep. 2017;14:110-121.
[PubMed Abstract] -

Ottiger C, Gygli N, Huber AR. Detection limit of architect hepatitis C core antigen assay in correlation
with HCV RNA, and renewed confirmation algorithm for reactive anti-HCV samples. J Clin Virol.
2013;58:535-40.
[PubMed Abstract] -

Panagiotakopoulos L, Sandul AL, Conners EE, Foster MA, Nelson NP, Wester C. CDC Recommendations
for Hepatitis C Testing Among Perinatally Exposed Infants and Children - United States, 2023. MMWR
Recomm Rep. 2023;72:1-21.
[PubMed Abstract] -

Tillmann HL. Hepatitis C virus core antigen testing: role in diagnosis, disease monitoring and
treatment. World J Gastroenterol. 2014;20:6701-6.
[PubMed Abstract] -

Ward JW, Lok AS, Thomas DL, El-Serag HB, Kim WR. Report on a single-topic conference on "Chronic
viral hepatitis--strategies to improve effectiveness of screening and treatment". Hepatology.

Page 10/20
2012;55:307-15.
[PubMed Abstract] -

Weber NC, Klepser ME, Akers JM, Klepser DG, Adams AJ. Use of CLIA-waived point-of-care tests for
infectious diseases in community pharmacies in the United States. Expert Rev Mol Diagn.
2016;16:253-64.
[PubMed Abstract] -

Page 11/20
Figures

Figure 1 HCV Third-Generation EIA Test

The third-generation HCV EIA is a qualitative test that detects human antibodies. This image shows several
combinations of proteins used in different third-generation HCV EIA tests.

Page 12/20
Figure 2 (Image Series) - OraQuick HCV Rapid Antibody Test (Image Series) - Figure 2 (Image
Series) - OraQuick HCV Rapid Antibody Test
Image 2A: Test Kit Set-Up

This image shows the test device after it has been placed into the buffer in the developer solution vial. The
test should be read 20 to 40 minutes after it is placed in the buffer.

Source: Image courtesy of OraSure Technologies, Inc.

Page 13/20
Figure 2 (Image Series) - OraQuick HCV Rapid Antibody Test
Image 2B: Test Device

The OraQuick HCV Rapid Antibody Test can detect HCV antibodies in whole blood (obtained by fingerstick or
venipuncture). The test device has control (C) and test (T) zones. If a line is visible only in the C zone (device
on left), the test is considered nonreactive. If lines are visible in both the T and C zones (device on right), the
test is considered reactive.

Source: Image courtesy of OraSure Technologies, Inc.

Page 14/20
Figure 3 HCV Testing Sequence for Identifying Current HCV Infection

This diagram shows the HCV testing sequence recommended by the Centers for Disease Control and
Prevention in May 2013.

Source: Centers for Disease Control and Prevention (CDC). Testing for HCV infection: an update of guidance
for clinicians and laboratorians. MMWR Morb Mortal Wkly Rep. 2013;62:362-5.

Page 15/20
Figure 4 CDC Recommendations for Counseling for Persons with a Positive HCV RNA Test

The CDC recommends that persons newly diagnosed with HCV infection should receive some basic post-test
counseling messages.

Source: Smith BD, Morgan RL, Beckett GA, et al. Recommendations for the identification of chronic hepatitis
C virus infection among persons born during 1945-1965. MMWR Recomm Rep. 2012;61:1-32.

Page 16/20
Figure 5 Interpretation of HCV Test Results and Recommended Action

Source: Centers for Disease Control and Prevention (CDC). Testing for HCV infection: an update of guidance
for clinicians and laboratorians. MMWR Morb Mortal Wkly Rep. 2013;62:362-5.

Page 17/20
Table 1.

Interpretation of Hepatitis C Diagnostic Test Results

HCV Antibody HCV RNA Interpretation Further Action /

Counseling
Positive Positive Current, active Provide
HCV infection appropriate
counseling
regarding active
HCV infection and
link the individual
to treatment
Positive Negative Prior exposure to Individual remains
HCV; no current susceptible to HCV.
HCV infection. No linkage to care
Consistent with required.
spontaneous
clearance or prior
HCV treatment.
Negative Positive Acute HCV Provide
infection. appropriate
HCV likely acquired counseling
in the past 3 regarding active
months. HCV infection and
link individual to
treatment.
Negative Negatvie No HCV infection. Individual remain
susceptible to HCV.
No linkage to care
required

Page 18/20
Table 2.

New Diagnosis of Hepatitis C Infection: Post-Test Counseling Messages

Persons diagnosed with hepatitis C can benefit from the following messages:
Contact a health-care provider (either a primary-care clinician or specialist [e.g., in
hepatology, gastroenterology, or infectious disease]), for:
Medical evaluation of the presence or development of chronic liver disease;
Advice on possible treatment options and strategies; and
Advice on how to monitor liver health, even if treatment is not recommended.
Protect the liver from further harm by:
Considering hepatitis A and B vaccination if susceptible and if liver disease is present;
Reducing or discontinuing alcohol consumption;
Avoiding new medicines, including over-the-counter and herbal agents, without first checking
with their health-care provider; and
Obtaining HIV risk assessment and testing.
For persons who are overweight (BMI ≥25kg/m2) or obese (BMI ≥30kg/m2):
Consider weight management or losing weight and
Follow a healthy diet and stay physically active.
To minimize the risk for
transmission to others:
Do not donate blood,
tissue, or semen and
Do not share
appliances that
might come into
contact with blood,
such as
toothbrushes, dental
appliances, razors,
and nail clippers.
Abbreviations: BMI = body mass index
Source:

Smith BD, Morgan RL, Beckett GA, et al. Recommendations for the identification of chronic hepatitis C
virus infection among persons born during 1945-1965. MMWR Recomm Rep. 2012;61:1-32. [PubMed
Abstract]

Page 19/20
 Page 20/20

Powered by TCPDF (www.tcpdf.org)