FDA has publicly posted test performance data from five antibody, or serology, test kits for covid-19. Performance data for additional kits will be made available as FDA reviews the results and determines whether further actions are appropriate for those test kits prior to publication.1
Posted on the agency’s website at www.open.fda.gov, the performance data were developed as part of an independent performance validation study undertaken in conjunction with the Biomedical Advanced Research and Development Authority (BARDA); the Centers for Disease Control and Prevention (CDC); and the National Cancer Institute (NCI), a component of the National Institutes of Health (NIH).2
The intergovernmental team is evaluating certain antibody tests for covid-19, including those that were not the subject of an emergency use authorization (EUA) or pre-emergency use authorization, as well as those that are under FDA review. In line with updated FDA guidance on serology tests for covid-19, the agency now requires manufacturers to apply for an EUA in order to market their tests.
According to FDA, “if an EUA request is not submitted by a commercial manufacturer of a serology test within a reasonable period of time, or if significant problems are identified with such a test that cannot be or have not been addressed in a timely manner, FDA intends to remove the manufacturer and test from the notification list.”3 Three of the first five covid-19 serology tests evaluated by the agencies have since been withdrawn. The first five tested kits included the following:
- BioMedomics (Morrisville, SC): Covid-19 IgM/IgG rapid test kit (voluntarily withdrawn).
- Euroimmun (Lubeck, Germany): SARS-CoV-2 ELISA (IgG).
- Healgen (Houston): Covid-19 IgG/IgM rapid test cassette.
- Phamatech (San Diego): Covid-19 IgG/IgM rapid test (voluntarily withdrawn).
- Tianjin Beroni Biotechnology (Tianjin, China): SARS-CoV-2 IgG/IgM antibody detection kit (removed; should not be distributed).
“These data are the result of an important cross-government effort,” says FDA Commissioner Stephen M. Hahn, MD. “There’s been incredible teamwork across scientists at FDA, NCI, CDC, and BARDA, and I’m glad to be sharing the data with the wider research community. By posting these data publicly, we’re advancing not only Americans’ access to trustworthy tests, but also the wider field of research into serology testing.”
“We’re pleased to step up and provide NCI’s laboratory capacity and expertise to support this crucial partnership to further our understanding of antibody test performances,” says Norman E. Sharpless, MD, NCI director. “This speaks to the terrific convening power of the federal government and highlights the strength of cross-agency collaboration within the Department of Health and Human Services. NCI will continue to play its part by examining these kits and generating important data that supports FDA’s decisionmaking.”
For more information, visit FDA.
- Coronavirus (covid-19) update: FDA publicly shares antibody test performance data from kits as part of validation study [press release, online]. Silver Spring, Md: FDA, 2020. Available at: www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-publicly-shares-antibody-test-performance-data-kits-part-validation. Accessed June 8, 2020.
- Independent evaluations of covid-19 serological tests [online]. Silver Spring, Md: FDA, 2020. Available at: https://open.fda.gov/apis/device/covid19serology. Access June 8, 2020.
- FAQs on testing for SARS-CoV-2 [online]. Silver Spring: Md: FDA, 2020. Available at: www.fda.gov/medical-devices/emergency-situations-medical-devices/faqs-testing-sars-cov-2#serology. Accessed June 8, 2020.