The US Food and Drug Administration (FDA) has alerted clinical laboratory personnel and healthcare providers of the potential for false-positive results with Abbott Molecular’s Covid-19 test kits.

The two tests, Alinity m SARS-CoV-2 AMP Kit and Alinity m Resp-4-Plex AMP Kit are authorised by the FDA under emergency use authorization (EUA) for Covid-19 testing.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

In May last year, Alinity m SARS-CoV-2 AMP kit obtained EUA, which was revised this August.

It is intended for use in Clinical Laboratory Improvement Amendments (CLIA) of 1988-certified laboratories to carry out moderate or high complexity tests.

The Alinity m Resp-4-Plex AMP test was authorised by the FDA in March for use in CLIA-certified labs to conduct moderate or high complexity tests.

It is intended to detect and distinguish SARS-CoV-2, influenza A, influenza B and respiratory syncytial virus (RSV) in a single test.

The FDA noted that the false-positive results may be linked to the present mixing parameters of the polymerase chain reaction (PCR) reaction mixture. This may cause possible overflow carrying over into neighbouring wells in the test reagent tray.

Overflow into wells of true negative samples placed near positive samples in the assay tray could lead to false-positive results.

The regulatory agency recommended that clinical laboratory personnel and healthcare providers should consider positive results from tests using these kits to be presumptive.

Furthermore, the FDA advised considering retesting positive patient samples from the last two weeks with another authorised test.

The agency also recommended informing patients who obtained positive results using these kits from June onwards that they could have had a false positive test result.

At present, the FDA is collaborating with Abbott Molecular to rectify the issues with these molecular testing kits.