FDA alerts providers to false positives with two Abbott SARS-CoV-2 test kits

The Food and Drug Administration Friday alerted clinical laboratory staff and health care providers to the potential for false positive results with two test kits made by Abbott Molecular to detect SARS-CoV-2. The agency recommends providers consider presumptive any positive results from the Alinity m SARS-CoV-2 AMP Kit, List Number 09N78-095, and Alinity m Resp-4-Plex AMP Kit, List Number 09N79-096; consider retesting positive patient specimens performed in the last two weeks with an alternate authorized test and informing patients with positive results since June that their results may have been false positives; and report any issues using the tests to FDA. Only laboratories certified to perform moderate or high complexity tests under the Clinical Laboratory Improvement Amendments can use these test kits.