Home 5 Articles 5 False Positive Recalls Casts Doubt on Rapid COVID Screening Tests at the Worst Possible Time

False Positive Recalls Casts Doubt on Rapid COVID Screening Tests at the Worst Possible Time

by | Oct 23, 2021 | Articles, Clinical Diagnostics Insider, Diagnostic Testing and Emerging Technologies, FDA-dtet

Late last year, the US Food and Drug Administration (FDA) began issuing emergency use authorization (EUA) for a new breed of COVID-19 tests designed not so much to diagnose but screen for the virus on a rapid and scalable basis at the point of care. But in recent months, accuracy problems have come to light that have resulted in a series of recalls of these tests. The most recent recall came on Oct. 15 when the FDA issued a Class 1 recall for a pair of high throughput tests from Abbott Laboratories. The Rapid COVID-19 Testing Linchpin The stakes are incredibly high. As the pandemic has drawn on, the focus of diagnostic testing has shifted to rapid point-of-care and over-the-counter, at-home products allowing for screening the asymptomatic population. Many of these tests are sold over the counter by retail giants like Amazon, CVS, Walmart and Target. Last month, the Biden Administration unveiled a plan calling for the federal government to spend $2 billion to make these tests more widely available to the public. But while they offer scalability and speed, questions remain about whether rapid at-home and high throughput COVID-19 screening tests are accurate enough to provide a reliable solution. […]

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