FDA Warns of False Positives From Abbott’s Alinity COVID-19 Tests

September 22, 2021

Two of Abbott Molecular’s Alinity COVID-19 tests may return false positive results, the FDA warned healthcare providers and clinical laboratory staff.

The tests are the Alinity m SARS-CoV-2 AMP kit and the Alinity m Resp-4-Plex AMP kit. The first reagent kit has an Emergency Use Authorization from the FDA for use in laboratories, while the Resp-4-Plex AMP kit is only authorized for use in laboratories certified to perform moderate- or high-complexity tests.

The false positive results may be linked to the polymerase chain-reaction mixture slopping over from positive samples into negative samples, the agency said.

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