The Institute for Functional Medicine’s COVID-19 Task Force has developed a set of practical questions to help you assess the validity of COVID-related serological tests.
There are many such tests flooding the market. They vary widely in sensitivity, specificity, predictive value, and level of validation against cross-reactivity with other viruses.
For each test you’re considering, ask about sensitivity, specificity, and the coefficient of variation.
- Where are you obtaining the kits or reagents to do your testing?
- What are the control samples? Are you using clinical samples as opposed to ‘spiked’ (i.e., artificial) samples?
- Are you using confirmed SARS-CoV-2 positive samples, and if so, how and when was this confirmed?
- If an antibody test, when was the sample collected in relation to a positive viral RNA test?
- What are the demographics of the clinical test population?
- Did the positive test population have symptoms?
- Were pre-pandemic samples used in the negative test group?
- Did the assay evaluate samples that had exposure to other respiratory viruses such as influenza and RSV, as well as other coronaviruses, to determine cross reactivity and specificity?
- How many samples were used in the validation?
- Are you doing progressive validation studies after the test is released
Adapted from the Institute for Functional Medicine’s “Assessment of Accuracy, Analytical and Clinical Validity of Lab Testing”