Rapid coronavirus antigen tests may give false positives, FDA warns
The Food and Drug Administration (FDA) warned about the possibility of false positives that can occur when using rapid antigen tests to detect coronavirus, particularly if the test is not used correctly. The regulatory agency said it has received reports of false-positive results occurring in nursing homes and other health care settings.
The agency warned that reading the test results either before or after the specified time provided in the instructions can result in false-positive or false-negative results. It also referenced the antigen EUA conditions of authorization, which specifies that authorized laboratories are to follow the manufacturer’s instructions for use regarding administering the test and reading the results.
Mishandling the test, or not ensuring that it’s been stored properly before use, could also result in a skewed result. Processing multiple specimens at once may also affect test results, as it may make it difficult …continued .
[Source: Fox News]