The document outlines the objectives, features, and methodologies of point-of-care testing (POCT), which provides rapid clinical laboratory testing at or near the site of patient care. It emphasizes the importance of quality control, adherence to protocols, and collaboration among healthcare professionals to enhance patient management outcomes. Various testing modalities, including simple test strips and complex immunoassays, are discussed, highlighting their applications, advantages, and limitations in medical diagnostics.

1. Point of Care Testing

2. Objectives
• Identify appropriate indications for point-of-care
testing based on patient presentation and clinical
scenario.
• Apply quality control measures and perform regular
maintenance and calibration of point-of-care testing
equipment to ensure accurate and reliable results.
• Implement point-of-care testing procedures following
established protocols, including proper specimen
collection, handling, and storage.
• Collaborate with other healthcare professionals in the
interpretation and integration of point-of-care test
results into patient management plans.
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3. Introduction
• POCT is clinical laboratory testing conducted
close to the site of patient care where care or
treatment is provided.
• It provides rapid turnaround of test results
with the potential to generate a result quickly
so that appropriate treatment can be
implemented, leading to improved clinical or
economic outcomes compared to laboratory
testing.
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4. Introduction
• POCT can be performed by various healthcare
professionals and, in some cases, even by
patients themselves.
• By leveraging the expertise of different
healthcare professionals, POCT can be
effectively integrated into patient care, leading
to improved outcomes and patient
satisfaction.
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5. Introduction
• Traditional laboratory testing typically involves a multiple-
step process that includes collecting samples from the
patient at the bedside or the clinic, transporting them to a
centralized laboratory (often located far away), and then
subjecting the samples to several processing steps.
• The delay in treatment caused by the time-consuming
traditional laboratory testing can hinder timely clinical
decision-making.
• POCT addresses this challenge by bringing the laboratory to
the patient. Portable and handheld testing devices enable
healthcare workers to perform rapid testing on samples,
significantly reducing the time needed for medical decision-
making.
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6. Features of POCT
• POCT should be simple to use.
• Reagents and consumables should have
durable resistance during storage and use.
• POCT results should align with established
laboratory methods.
• POCT should ensure safety during testing.
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7. ASSURED Guidelines
This are key criteria for effective POCT, as proposed by
the World Health Organization (WHO)
• Affordable,
• Sensitive,
• Specific,
• User-friendly,
• Rapid,
• Robust,
• Equipment-free,(means no complex equipment
required)
• and Delivered (to the end user)
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8. Specimen Requirements and Procedure
• Adhering to the manufacturer's instructions for
use (MIFU) or package insert is crucial in ensuring
accurate testing in POCT.
• It is recommended to wait at least 15 minutes
after a blood transfusion before drawing a sample
for POCT.
• Samples collected for blood gas analysis are
susceptible to changes in oxygen partial pressure;
therefore, it is crucial to maintain anaerobic
conditions during sample collection to ensure
accurate laboratory values.
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9. Classification of POCT
• POCT testing devices are classified based on
the testing modality and the test size.
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10. Testing modalities
Testing Strips and Lateral-flow Testing
• The most basic POCT takes advantage of an interaction between an
analyte and a substance, usually impregnated or contained, so that
a sample can be added or mixed in a controlled manner.
• An example is using test strips (eg, urine test strips). These strips
are generally dried, porous matrices with impregnated carrier
elements that interact with the analyte(s) when exposed.
• The interaction between the analyte and the testing reagents often
involves a chemical reaction that produces a color change.
• This color change can be interpreted as a binary value indicating the
presence or absence of the analyte or as an indication of the
analyte concentration using a scale (eg, trace protein, 1+, 2+, 3+).
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11. • A more complex approach to POCT is lateral-flow
testing. This type of diagnostic testing utilizes a
layer of supporting material, such as porous
paper of cellulose fiber filters or woven meshes.
The supporting material contains capillary beds
to whisk fluid samples to location(s) on the
support material with substances that react with
measured analytes in the sample. A well-known
example is the at-home pregnancy test, which
commonly utilizes an immunoassay to detect the
presence of human chorionic gonadotropin (hCG,
specifically beta-hCG) in urine.
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12. • Urine is exposed to one end of the supporting material in
the test device; capillary beds then move the urine through
the supporting material to specific sites that react with
beta-hCG.
• This configuration commonly has 2 lines of reactive
material, one that serves as the control and another that
indicates a binary yes or no indication.
• The test is positive if both lines (also known as stripes)
appear or change color and negative if only the control line
is visible.
• Failure of the control line to appear indicates an invalid or
faulty test, which could result from a manufacturing defect,
damage, or expired test
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13. • In many instances, POCTs that utilize simple
test strips or lateral-flow testing provide
qualitative or semiquantitative results and do
not provide precise
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14. Immunoassays
• POCT testing that utilizes immunoassays relies
on antibodies to bind to a specific target when
the concentration exceeds a certain
threshold.[14] Targets in immunoassays for
POCT can encompass a wide range of
substances, including proteins, drugs, and
pathogens. POCTs are available in various
formats, including both individual tests and
platforms with multiple built-in tests
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15. • Could be Competitive assays or non-
competitive assays
• Unlike simple test strip-based POCT,
immunoassay POCT provides quantitative
information for specific analytes.
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16. Antigen-based Testing
• POCT, which involves the detection of known antigens or
antibodies specific to a particular disease or disease state,
has been widely employed as a common practice in
healthcare.
• Immunoassay-based POCT is commonly used to rapidly
detect group A Streptococcus, mononucleosis, and
influenza A and B. These tests utilize immunoassays that
bind specific antigens or antibodies.
• Immunoassay-based POCT offers a fast turnaround time
(TAT) but may have lower sensitivities and specificities
compared to traditional laboratory and molecular testing
methods.
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17. Molecular POCT
• The demand for molecular POCT with high
sensitivity and specificity and a relatively short
turnaround time (although longer than antigen-
based testing) spurred its development.
• This form of testing detects DNA or RNA
sequences indicative of the presence of disease.
Nucleic acid amplification testing (NAAT) is used
to identify DNA or RNA in small test samples. T
• he nucleic acids of interest are replicated to
increase their concentration (ie, amplify them) so
they are easier to detect
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18. • There are various forms of this testing,
including reverse transcription polymerase
chain reaction (RT-PCR) and isothermal
amplification methods such as nicking
endonuclease amplification reaction (NEAR)
and transcription-mediated amplification
(TMA).
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