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


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2021 Sep 17, 3:26pm   165 views  2 comments

by Al_Sharpton_for_President   ➕follow (5)   💰tip   ignore  

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.

hhttps://www.genomeweb.com/molecular-diagnostics/fda-warns-potential-false-positives-abbott-sars-cov-2-molecular-tests#.YUUV4y1h2v4



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1   DhammaStep   2021 Sep 17, 3:30pm  

At this point I have the urge to revert back to my old internet ways of posting images of people laughing and memes. We were all calling this stuff for so long that I might lose my mind from such sheer vindication overload.


2   HeadSet   2021 Sep 17, 4:35pm  

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

Cannot have that, now that so many are vaxxed and we want to hide breakthrough cases, not potentially embellish them.

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