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FDA - Independent Evaluations of COVID-19 Serological Tests
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https://open.fda.gov/apis/device/covid19serology/
Serology tests detect the presence of antibodies in the blood when the body is responding to a specific infection, like COVID-19. In other words, the tests detect the body's immune response to the infection caused by the virus rather than detecting the virus itself. In the early days of an infection when the body's immune response is still building, antibodies may not be detected. This limits the test's effectiveness for diagnosing COVID-19, and this is one reason serology tests should not be used as the sole basis to diagnose COVID-19. Serology tests could play a role in the fight against COVID-19 by helping healthcare professionals identify individuals who may have developed an immune response to SARS-CoV-2. In addition, these test results can aid in determining who may donate a part of their blood called convalescent plasma, which may serve as a possible treatment for those who are seriously ill from COVID-19. However, to use serology tests properly, it is important to understand their performance characteristics and limitations. Moreover, studies are underway to address questions that will better inform the appropriate use of these tests, such as whether the presence of antibodies conveys a level of immunity that would prevent or reduce the severity of re-infection as well as the duration for which immunity lasts.
Summary test results
Where the Marketing Status below is shown as "EUA Authorized," FDA has reviewed data generated by the developer and the independent evaluation and determined, among other things, that based on the totality of the evidence available, that the test may be effective in identifying the presence of antibodies to SARS-CoV-2 as described in the Letters of Authorization for each test, and that the known and potential benefits of the test when so used outweigh the known and potential risks. Such tests are authorized by FDA under Emergency Use Authorizations (EUA) and may be distributed and used as set forth in the EUA. Where the Marketing Status below is shown as "Should not be distributed – Voluntarily withdrawn," the manufacturers have voluntarily stopped distribution and requested FDA to remove their test from the list of commercial manufacturers distributing serology test kits under the policy outlined in Section IV.D of the Policy for Coronavirus Disease-2019 Tests. Where the Marketing Status below is shown as "Should not be distributed – Removed," either an EUA request has not been submitted within a reasonable period of time as outlined in the Policy for Coronavirus Disease-2019 Tests or FDA has determined not to issue an EUA for the test.
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