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Paper says Abbott 5-minute COVID-19 testing device is flawed

The new data questions how far off COVID-19 numbers actually are in the United States.

A paper claiming Abbott ID NOW COVID-19 tests had missed a third of all positive samples has been verified and published by the Journal of Clinical Microbiology.

The findings received peer review and published May 29th.

The devices were running across the United States during the pandemic. Only now experts have begun to phase out some of the devices after the FDA issued a warning about inaccuracies with the devices in May.

According to researchers at NYU Langone Medical Center, Abbott ID NOW COVID-19 tests that had been granted Emergency Use Authorization (EUA) approval by the FDA back in March missed nearly half of all positive tests vs. traditional swab testing.

 “Regardless of method of collection and sample type, Abbot ID NOW COVID-19 missed a third of the samples detected positive by Cepheid Xpert Xpress when using NP swabs in VTM and over 48% when using dry nasal swabs,” Researchers say in the paper.

In one test conducted by researchers, the Abbott ID system used dry nasal swabs and detected only 16 of the 31 positive samples as positive results for COVID-19. 

The remaining 15 samples were falsely labeled negative by the system.

The new data questions how far off COVID-19 numbers actually are in the United States.

Abbott released a technical brief soon after the paper originally emerged saying negative tests should be treated as presumptive and tested with an alternative FDA authorized device. Abbott says a false negative can result if a specimen is improperly collected, transported or handled. 

The NYU Langone Medical Center study was conducted using tests obtained from suspected COVID-19 patients at New York University Langone Tisch Hospital.

The testing devices have been a key part of reopening the United States, with state-run facilities and hospitals using the machines to process their own locally sourced results.

The FDA granted approval for the Abbott ID NOW COVID-19 testing, but waved quality system requirements and required Abbott to print “This test has not been FDA cleared or approved” with the devices.   It was also not allowed to advertise or promote it as such under the EUA.

The Abbott ID NOW COVID-19 tests were promoted as being able to yield results in as little as 5 minutes, which has to lead to an increase in volunteer testing efforts across the Country.  Under the Abbott ID tests, the company claims positive results are available within 5-13 minutes and negative results within 13 minutes.

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