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FDA Warns On Potential False Positive Results With Abbott's COVID-19 Lab Tests

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  • The FDA has issued a letter to healthcare professionals alerting them to the potential for false-positive results with Abbott Laboratories (NYSE: ABT) two COVID-19 diagnostic tests.

  • Related Link: Abbott Destroyed Several COVID Test Cards, Now Faces Diminished Capacity: NYT.

  • The alert relates to the Alinity m SARS-CoV-2 AMP Kit and the Alinity m Resp-4-Plex AMP Kit.

  • The FDA says that the false positives may result from 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 positioned near positive samples in the assay tray could produce false-positive results.

  • The agency suggests that providers consider any positive tests from these kits to be presumptive and retest with another type.

  • Abbott told Benzinga in an emailed statement that is implementing an update to its Alinity m SARS-CoV-2 EUA assay. The update to the SARS-CoV-2 EUA assay is nearly complete. The company is also updating the Resp-4-plex EUA assay, which will be completed in next two weeks (in the U.S.).

  • Read Next: Why Biden's Action Plan Is Bullish For COVID-19 Testing Stocks.

  • Price Action: ABT shares are down 0.35% at $126.99 during the market session on the last check Friday.

  • Editor's Note: The story has been updated with additional emailed statement from Abbott

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