Enclonar, Kimberly / MLS 3A

History of Automation
Validation of Equipment • 1950s introduced
November 5, 2020
• 1957: Autoanalyzer I
Cynthia Dayoan, RMT o First automated analyzer using a flow technique
called continuous flow analysis (CFA)
Laboratory machines include all conceivable machines o Invented by Leonard Skeggs, PhD
that are used in the laboratory and conduct syntheses and o The first applications were for clinical analysis,
analyses. The operational area of laboratory machines
but methods for industrial and environmental
includes the development of new products, the processing of
analysis soon followed.
smallest quantities as well as quality control. Among others, o The design is based on segmenting a
some of the advantages of laboratory machines are a
continuously flowing stream with air bubbles
considerable acceleration and facilitation of work procedures
• 1969: SMA (Sequential Multiple Analyzer)
in laboratories. Nevertheless, the most important advantage
• 1974: SMAC (Sequential Multiple Analyzer with
is the ability to reproduce once achieved results. Due to a
Computer)
thorough documentation and the laboratory machines’
precise mode of operation, results can be reproduced nearly Machine Automation
identically.
• Any information technology that is designed to
When choosing the appropriate laboratory machine, a
control the work of machines
basic distinction is made between machines for the
• It is an instrument or set of instruments that
automation of a procedure-technical laboratory process and
standardize workflow in a clinical laboratory by
machines which are used for the automation of an analyzing
accepting, processing, and resulting specimens
laboratory. Among others, examples for the use of
• Specimens include blood samples and bodily fluids to
laboratory machines in analytic laboratories are the
test hematology, chemistry, molecular, anatomic
processing of test tubes by identification, pipetting,
pathology, and microbiology samples.
registration and sorting or the automatic capturing of
• A total laboratory automation means that a track
measuring values. The application possibilities of laboratory
system connects all aspects of the laboratory process,
machines are very varied and extensive. They are used in
including the receiving of the specimen and result.
chemistry, physics, biology, medicine and also in pharmacy.
• Each automation system is chosen for individual
On account of the special chemical, physical and biological
laboratories based on their workflow and demand.
influences their laboratory machines are exposed do, the
highest demands are made on the construction materials
used. Type of Analysis Method
Automation
Clinical Laboratory Autoanalyzer A continuous flow analysis tests
• Healthcare facilities providing a wide range of (continuous flow multiple samples at one time, while
laboratory procedures which aid the physicians in analysis or a a sequential analysis tests one
carrying out the diagnosis, treatment, and sequential sample at a time and are resulted in
management of patients. analysis) the order they are tested.
Closed Uses instruments that only work
3 Phases of Laboratory Testing
automation with other pieces of equipment that
• Pre-pre-analytical - patient and client interaction are manufactured by the same
• Pre-analytical - medtech company.
• Analytical
• Post-analytical Open automation Uses instruments that exist
• Post-post-analytical - client and result independently of each other and
can interface with other pieces of
Semi-automation equipment from different
• Process or procedure that is performed by the manufacturers.
combined activities of Medical technologist and Discrete analysis Each sample is analyzed in an
machine individualized reaction chamber
• Responsive touch-screen display with icon-based where reagents are added
software separately.
• Allows the user to easily navigate through the various
different features of the analyzer Single-channel A dedicated channel is used for each
• Features, such as automatic aspiration and automatic analysis single test.
flagging of errors, guarantees precision, reliability and Multiple-channel Several analyses are done at one
accuracy of results analysis time using two or more channels for
the test.
Procedure for Glucose Determination in Semi-automation
Random access Specimens are tested in or out of
analysis the order they are received based
on when required channels are
available.
Assays Completes tests where there is a
fixed time for the reaction to be
finished (end-point test) ,or
completes a continuous monitored
test where several data results are
collected at specific time intervals.
 Enclonar, Kimberly / MLS 3A
3 Basic approaches with Instrument Discrete Analysis
1. Continuous flow • Widely used
2. Centrifugal analysis • Developed in 1970
3. Discrete analysis • Each specimen in a batch --- separate from every
other specimen.
• All three can use batch analysis (large number of • Keep sample separate throughout the testing process,
specimens in one run). dispensing precise amounts when required.
• Discrete analyzers offer random-access, or stat, • Rotating individual cuvettes through the instrument
capabilities. instead of releasing the sample in a continuous
stream cuts down on reagent waste and can produce
Continuous Flow Analysis (CFA) hundreds of results per h.
• Traditional
• A sample is injected into a flowing carrier solution Advantages
passing rapidly through small-bore tubing. 1. These machines are robust and produce reliable
• The sample is mixed with a reagent, which reacts with results with minimum problems.
the sample to develop a color and determine the 2. These are high throughput machines that can analyze
sample concentration. up to 75 samples in one go for single or multiple
• The use of carefully controlled flow conditions testing.
ensures that the color development reaction is 3. Require little volume of sample and reagents.
reproducible, so that the color measurement need 4. Results are directly sent to the clinics via compatible
not wait until the reaction has gone to completion. computer system
• It uses air bubbles at regular intervals serves as 5. Printers may be attached for printing data and error
separating and cleaning media. charts for the control samples.
• A heating bath maintains the required temperature of
the reaction to allow complete color development --- Disadvantages
reaction rate is controlled by temperature. 1. Are expensive to purchase
2. Produce a lot of waste
Disadvantages 3. Are expensive to maintain
1. The machine does not allow test selection; all tests 4. Since each sample is in a separate reaction container,
must be performed even if not requested. uniformity of quality must be maintained in each
2. The machine must run continuously even when there cuvette so that a particular sample quality is not
are no tests. affected by the cuvette it is placed in.
3. Because of the continuous flow, reagents must be
drawn at all times even when there are no tests to 2 Formats
perform; which results in reagent wasting. Therefore Direct reading Discrete Analyzer
a good stock of reagents must be available to avoid • Transfers via the robotic arm, the sample and
system malfunction due to reagent depletion. reagents direct to the cuvette where the optical
4. The instrument must be closely monitored all the density will be read.
time for air bubbles uniformity; reagent availability • Benefits:
and tubing integrity and most important of all carry o Disposable, single use reaction cuvettes, no
over problems. clean-up of cuvettes
5. Multi-channel machines are usually large in size and o Cheaper instrument purchase price
occupy large space.
Indirect reading Discrete Analyzer
Centrifugal Analysis • Initially transfers the sample and reagents to an
• It uses the force generated by centrifugation to intermediate reaction cuvette where the color
transfer and then contain liquids in separate cuvettes development progress’.
for measurement at the perimeter of a spinning rotor. • Once the sample color has saturated, optical density
• Most capable of running multiple samples, one test at plateaus in the reaction cuvette, it is pumped through
a time, in a batch. a common flow-through cell, used for all samples
• Batch analysis – major advantage where the optical density is measured.
• Benefits:
Advantages o Reaction occurs in the final measuring cuvette,
1. Rapid test performance analyzing multiple samples. no intermediate reaction cell cost
2. Batch analysis is a major advantage because reactions o Greater accuracy with less transferring of
in all cuvettes are read simultaneously. solutions
3. Requires small sample (as little as 2μL of plasma, o Less reactant needed, lower consumable costs
serum, urine or whole blood). o Faster sample throughput
4. Uses small reagent volumes (250 μL). o No air-bubbles in the measurement cell. Indirect
5. Can be programmed to carry out many different assay flow through cell can create air bubbles.
methods.
LIS/LMS
Disadvantages • platforms brought electronic data management to the
1. Only one test type can be performed each time. laboratory to manage the workflow and electronic
2. The quality of cuvette and uniformity of detection interfaces to the instruments.
window is crucial. • laboratory information systems/laboratory
3. Only reputable companies should be dealt with which information management systems began to take
adds to the cost of analysis. shape in the 1970s.
• pre- and post-analytic portions