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FDA Warns of Potential False Positives With Abbott SARS-CoV-2 Molecular Tests

NEW YORK – The US Food and Drug Administration on Friday posted a warning to clinical labs that two of Abbott's kits for the molecular detection of SARS-CoV-2 could result in false positives.

Both the Alinity m SARS-CoV-2 AMP Kit and Alinity m Resp-4-Plex AMP Kit could have a potential for false positives, possibly related to current mixing parameters of the PCR reaction mixture that may result in overflow carrying over into neighboring wells in the test reagent tray.

This overflow into wells of true negative samples positioned near positive samples in the tray could produce false positives, the agency said in an alert posted to its website.

The FDA recommends clinical lab staff consider any positive result from tests using the kits to be presumptive and retest positive patient specimens with an alternate authorized test. It also recommended telling patients who received positive results from the kits beginning in June that they may have had false positive test results.

The FDA said it is working with Abbott to resolve the issues. A spokesperson for Abbott said the company is implementing updates to the system to address the issue. The update for the SARS-CoV-2 test is nearly complete, while the update for the 4-plex test is expected to be finished in the next few weeks.

The SARS-CoV-2 test received Emergency Use Authorization from the FDA in May 2020 and has been granted multiple revisions, the most recent of which came in August. The multiplex respiratory test, which detects SARS-CoV-2, influenza A and B, and respiratory syncytial virus, received EUA in March.