The FDA is changing the way it conducts COVID-19 antibody testing during a coronavirus pandemic, and it is stepping up oversight in the field after at least one unreliable serological test was published. The purpose of the antibody test is not to determine whether a patient is currently infected with COVID-19, but to show whether they have recently been infected with COVID-19. Therefore, they consider themselves to be important tools for the current control of coronaviruses and to manage their spread.
It is difficult to determine the extent of community transmission in any one location without knowing how many people may have been exposed to the virus, especially if some people may not show any symptoms.
Antibody testing also helps determine which people may have useful “rehabilitation plasma” in their blood, which contains antibodies produced by an individual’s previous successful response to a COVID-19 infection that could be used as a treatment or treatment for another person who is struggling with the infection.
Initially, the U.S. Food and Drug Administration (FDA) took a fairly broad approach to serological testing. The flexibility in the March 16 policy allows early use of antibody testing to begin answering questions about the prevalence of COVID-19 infections in different populations and whether the presence of antibodies will transmit immunity and, if so, for how long. Early availability of serological testing helps to generate important information that can inform the future use of serological testing.
While this is done to get serological tests into use as quickly as possible, it has also led to concerns that unproven tests may give false readings, and that some tests may be falsely claimed to be FDA-approved or authorized, and some to advertise testing at home. At the same time, false positive results also appear, that is, when this condition occurs, it is impossible to judge the actual immunity.
Now, the FDA is enforcing new, stricter rules for antibody testing. Reagent manufacturers must now submit an Emergency Use Authorization (EUA) application to the FDA within 10 working days of notifying the FDA for validation testing, including their validation data, and “specific performance threshold recommendations for specific performance thresholds for specificity and sensitivity” for any company that develops serological testing.
Almost half of the testing programs offered by commercial manufacturers are already the subject of ANEUA review, or pre-submission sought by THE EUA, which provides developers with an opportunity to start sharing data with the FDA or seeking advice. To date, 12 antibody testing programs have been authorized by a single EUA, most of them in the past few days, and more than 200 antibody testing programs are currently under EUA or EUA review.
Verification will be conducted using facilities at the National Cancer Institute (NCI), the U.S. Food and Drug Administration, the National Institutes of Health, the Centers for Disease Control and Prevention, and the National Cancer Institute (NCI) established by the Biomedical Advanced Research and Development Agency. So far, 13 test kits have been validated by the National Cancer Institute and data is shared with the FDA for review prior to release.
The reality is that no test is 100% accurate, and false positives and false negatives are inevitable. However, the new policy is designed to give hospitals and health care providers more confidence that the antibody tests they use will give the most meaningful and reliable results.