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Figure 3. Example of lateral flow assay. Top of figure is enlarged representation of how assay is set up and where
sample is applied, middle of figure is representation of the conformation of test components seen at end of a positive
test, and bottom of figure indicates how the readout of different test results would appear to the user.

(i.e., when the same sample is tested repeatedly, it should • What are the demographics of the clinical test
produce the same result). population?
Clinical validity, on the other hand, is the correct • Did the positive test population have symptoms in
response for the patient tested rather than the sample In addition to a positive PCR test?
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order to ensure clinical validity, one must ask a number of • Were pre-pandemic samples used in the negative
questions about the validation process, including: test group?
• Did the assay evaluate samples that had exposure to
• Where is the lab obtaining the kits or reagents? (Most other respiratory viruses such as influenza and RSV,
RDT kits are currently purchased from China). as well as other coronaviruses, to determine cross
• What are the control samples? Is the lab using clinical reactivity and specificity?
samples as opposed to ‘spiked’ (i.e., artificial) samples? • How many samples were used in the validation?
• Is the lab using confirmed SARS-CoV-2 positive • Is the lab doing progressive validation studies after
samples, and if so, how and when was this confirmed? the test is released?
• When was the sample collected for antibody testing
in relation to a positive viral RNA test?

50 Integrative Medicine • Vol. 19, No. S1 • Epub Ahead of Print Messier—Primer on SARS-CoV-2 Testing