Evaluating COVID Serology Tests

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.

Also ask:

  • 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”

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