06/05/2020
[USA]
5/5/2020 -- New Info About Antibody Tests & FDA
*The FDA has come out with new standards for antibody tests because a number of fake or low accuracy tests have been flooding the market.
*The FDA implies at the end of the update that antibody tests should only be used with doctor supervision or as part of a study or other situation where the results can be properly interpreted by experts.
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QUOTES
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"We unfortunately see unscrupulous actors marketing fraudulent test kits and using the pandemic as an opportunity to take advantage of Americans’ anxiety. Some test developers have falsely claimed their serological tests are FDA approved or authorized. Others have falsely claimed that their tests can diagnose COVID-19 or that they are for at-home testing, which would fall outside of the policies outlined in our March 16 guidance, as well as the updated guidance. Also, since that time, the FDA has become aware that a concerning number of commercial serology tests are being promoted inappropriately, including for diagnostic use, or are performing poorly based on an independent evaluation by the NIH."
"Under this revised policy, the FDA has outlined the following expectations for antibody test developers:
----Commercial manufacturers will submit EUA requests, with their validation data, within 10 business days from the date they notified the FDA of their validation testing OR from the date of this policy, whichever is later.
----Furthermore, the FDA has provided specific performance threshold recommendations for specificity and sensitivity for all serology test developers."
"That is why antibody tests should only be used as part of a well-conceived testing plan and why the results should always be interpreted by appropriate experts."
FDA has issued an update to a policy from March 16, 2020 on antibody tests for COVID-19.