Quality Testing Using Sars-Cov-2 Antigen Rdts

04
Quality testing using

SARS-CoV-2 Antigen
RDTs
Learning objectives
At the end of this module, you should be able to:
• describe what is quality testing and why is it important
• explain the types of inaccurate results and their consequences
• list common errors in the pre-testing, testing and post-testing phases and
how to avoid them.
SARS-CoV-2 Antigen Rapid Diagnostic Test online course– v1.0 | Quality testing using SARS-CoV-2 Antigen RDTs 2
What is a quality test and why is it important?
• A quality test is accurate and reliable, with results reported in a timely manner.
• Quality-assured SARS-CoV-2 Antigen RDT testing is critical for the correct

management of patients.
• As health workers performing SARS-CoV-2 Antigen RDT testing, you are

critical to scaling up COVID-19 testing in your country and saving lives.
• It is your responsibility to ensure the quality of the tests you perform by

avoiding errors in testing.
When do testing errors occur?
Store test kits Test the right Read and

correctly sample record the
Before Select the right During Follow the correct After result correctly
testing people for testing testing test procedure testing
Collect samples Perform quality Report the
correctly control right result
At all stages of the testing process
Inaccurate results
• Inaccurate results may result in:
• a person without SARS-CoV-2 infection being classified as having

COVID-19 (false positive)
or
• a person with SARS-CoV-2 infection being classified as not having
COVID-19 (false negative)
• Invalid results require the collection of an additional sample. If the person

does not return to the health facility, a possible COVID-19 diagnosis may
be missed.
Consequences of inaccurate results
• False-positive results incorrectly label an uninfected person as being
infected with SARS-CoV-2. Consequences include unnecessary
quarantine, stigma, psychological distress and unnecessary use of limited
resources on contact tracing.
• False-negative results mean that infected persons are not detected.

Therefore, they may not be isolated and can infect others. In addition,
patients with moderate or severe disease may not get appropriate care for
COVID-19.
Why do inaccurate results occur?
• Individual responsibilities are unclear.
• There are no written procedures.
• Written procedures are not followed.
• Training is not done or not completed.
• Checks are not done for transcription errors (results recorded incorrectly).
• Test kits are not stored properly.
• The inherent nature of the test itself (i.e. sensitivity and specificity).
• Quality control (QC) measures are not performed.
Errors before testing and how to avoid them
Error How to prevent or correct the error
Incorrect sample • Refer to the procedure/job aid for sample types that can be tested
type collected using a SARS-CoV-2 Antigen RDT.
Sample mislabelled • Cross-check labelling of the sample container with the sample
or unlabelled request form to ensure they are the same.
Sample stored or • Test the sample immediately after sample collection.
transported • Where samples have to be stored or transported from the collection
incorrectly before to the testing site, follow the manufacturer’s instructions on maximum
testing time and temperature of storage.
Test kits stored • Follow the manufacturer’s instructions on storage conditions.
incorrectly • Monitor the temperature of the storage room and testing site.
• Check expiry dates of kits and use kits with the earliest expiry
date first.
• Do not use kits that are past their expiry date.
Errors during testing and how to avoid them
Test is incorrectly • Cross-check labelling of the test with the sample request form
labelled to ensure they are the same.
Results reported when • Perform and review quality controls.
quality control results • Only report results if the tests have passed quality control.
are invalid
Wrong volume of • Follow the manufacturer’s instructions for the correct sample
sample added volume to be added.
Reagents stored • Follow the manufacturer’s instructions on storage conditions.
incorrectly or used after • Monitor the temperature of the storage room and testing site.
expiry date • Check expiry dates of kits and use kits with the earliest expiry
date first.
• Do not use kits that are past their expiry date.
Errors after testing and how to avoid them
Result reported on the • Cross-check labelling of the sample container with the
wrong patient sample request form, test and identifier on the report to
ensure they are the same.
Report illegible • Write clearly on the report so it can be understood by
others.
Report sent to the wrong • Check that the location on the sample request form is the
location same as on the report.
Key points
• Errors can occur at all stages of the testing process
• Inaccurate results may result in:

• a person without SARS-CoV-2 infection being
classified as having COVID-19 (false positive)
or
• a person with SARS-CoV-2 infection being classified
as not having COVID-19 (false negative)
• It is your responsibility to ensure the quality of the tests

you perform by avoiding errors in testing
For reflection
• Errors can occur at all stages of the testing process.

Reflect on the recommendations on how to avoid them:
• What strategies can you implement that will ensure SARS-

CoV-2 antigen RDTs quality testing?
• How can the effectiveness of these strategies be
measured across the diagnostic network?
• How will supervisory visits to testing sites be used to
ensure SARS-CoV-2 antigen RDTs quality testing in your
setting?
SARS-CoV-2 Antigen Rapid Diagnostic Test online course – v1.0 | Quality testing using SARS-CoV-2 Antigen RDTs 12

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04

Quality testing using

• Quality-assured SARS-CoV-2 Antigen RDT testing is critical for the correct

• As health workers performing SARS-CoV-2 Antigen RDT testing, you are

• It is your responsibility to ensure the quality of the tests you perform by

Store test kits Test the right Read and

At all stages of the testing process

• a person without SARS-CoV-2 infection being classified as having

• Invalid results require the collection of an additional sample. If the person

• False-negative results mean that infected persons are not detected.

• Inaccurate results may result in:

• It is your responsibility to ensure the quality of the tests

• Errors can occur at all stages of the testing process.

• What strategies can you implement that will ensure SARS-

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