April 28, 2020 / Madeleine Johnson, Genomeweb
Against a backdrop of dynamic federal regulations and a quickly expanding commercial landscape, labs are facing unusual obstacles in validating serology testing for COVID-19. Issues with test accuracy and supply, combined with a paucity of independent validations, mean most labs must basically start from scratch in vetting tests on their own.
Along with lab-based and high-throughput serology tests that can be validated as lab-developed tests, seven commercial serology assays have obtained Emergency Use Authorization from the Food and Drug Administration.
Additionally, there are currently 141 manufacturers that have notified FDA that they have validated and are offering serology tests in the agency’s Policy D — which are necessarily deemed high-complexity tests until they are evaluated in the EUA process. These serology tests are listed on the FDA’s website.
Serology tests, and particularly the lateral flow immunoassays, may or may not be available in large quantities as labs around the world scramble to acquire them, and few have been tested in large controlled trials. Sensitivity and specificity concerns—particularly in light of an unclear prevalence of SARS-CoV-2 infection in the U.S. — mean labs need to validate any test they bring before they use it on patients.
