FDA: Risk of false positives from some COVID tests

The Food and Drug Administration (FDA) alerted clinical laboratory staff and health care providers last week of a potential for false positive results with the Abbot Alinity m SARS-CoV-2 AMP Kit, List Number 09N78-095, and Alinity m Resp-4-Plex AMP Kit, List Number 09N79-096. The false positive results may be related to current mixing parameters of the PCR reaction mixture. These may result in overflow, which could carry over into neighboring wells in the assay reagent tray. The agency recommends clinical laboratory staff and health care providers consider any positive result from these tests to be presumptive and retest positive patient specimens performed in the last two weeks with an alternate authorized test. (FDA letter, 9/17/21)