There has been reports of false positives by some who have been tested leading some people to believe they have the virus and false negatives leaving people to think they do not have , or have had the virus…
The FDA has requested validation data for companies that have test units in use…
The results would be published with the hope that healthcare uses would discontinue using inaccurate brands….
Commercial manufacturers will now be required to submit data to the Food and Drug Administration (FDA) proving the accuracy of their antibody tests, a reversal of a previously controversial agency policy.
Under the new policy, announced Monday, manufacturers must apply for an emergency use authorization, with their validation data, within 10 business days from the date their products are available.
If commercial manufacturers that are currently marketing tests fail to apply for the approvals, the FDA said it intends to share that information publicly.
The agency also provided specific performance threshold recommendations regarding specificity and sensitivity for all test developers. Specificity measures how often the tests produce a correct positive result, while sensitivity measures how often the test shows a correct negative result.
Antibody tests have been heralded by state and federal leaders who hope they can help guide decisions about when and how to reopen the country by identifying who has been exposed to the virus and may now have immunity even if they have never been diagnosed.
COVID-19 has killed nearly 70,000 people and sickened more than 1.1 million in the United States alone.
But in the rush to get tests to the public quickly, the FDA allowed companies to market tests with little to no oversight, raising the potential for a surge in inaccurate results….