The U.S. Food and Drug Administration (FDA) said two SARS-CoV-2 Alinity test kits have the potential to produce false positive results.
The kits are the Alinity m SARS-CoV-2 AMP Kit and the Alinity m Resp-4-Plex AMP Kit, both from Abbott Molecular.
The FDA said the false positive results may be related to current mixing parameters of the PCR reaction mixture that may result in potential overflow that could carry over into neighboring wells in the assay reagent tray. Overflow into the wells of true negative samples that are positioned near positive samples in the assay tray could produce false positive results.
The FDA recommends that labs consider:
· Any positive result from tests using the Alinity m SARS-CoV-2 AMP and the Alinity m Resp-4-Plex AMP Kits to be presumptive. Consider retesting positive patient specimens performed in the last two weeks with an alternate authorized test.
· Communicating to patients who received positive results using the Alinity m SARS-CoV-2 AMP and the Alinity m Resp-4-Plex AMP Kits, starting in June 2021, that they may have had a false positive test result.
· Reporting any issues with using COVID-19 tests to the FDA.
The FDA issued an emergency use authorization (EUA) to permit emergency use of the Alinity m Resp-4-Plex AMP test on March 4, 2021. The Alinity m Resp-4-Plex AMP Kit is only authorized for use in laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to perform moderate or high complexity tests.
