July 8, 2021

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U.S. FDA probes accuracy challenge with Abbott’s speedy virus take a look at

United States well being officers are alerting medical doctors to a possible accuracy downside with a speedy take a look at for COVID-19 used at hundreds of hospitals, clinics and testing websites throughout the U.S., together with the White Home.

The Meals and Drug Administration mentioned late Thursday it’s investigating preliminary information suggesting Abbott Laboratories’ 15-minute take a look at can miss COVID-19 circumstances, falsely clearing sufferers of an infection. The take a look at is used each day on the White Home to check President Donald Trump and key members of his workers, together with the coronavirus activity pressure.

The warning got here sooner or later after researchers at New York College reported outcomes suggesting Abbott’s take a look at can miss as much as half the infections caught by a rival take a look at made by Cepheid.

The analysis has not been peer-reviewed or printed in a medical journal and was primarily based on about 100 sufferers.

The researchers discovered that Abbott’s take a look at, run on the corporate’s transportable ID NOW system, missed one-third of the infections caught by Cepheid’s take a look at when swabs had been saved in liquid used to move laboratory samples. When the samples had been stored dry the take a look at missed 48 per cent of the circumstances flagged by Cepheid’s take a look at.

The researchers known as the take a look at’s efficiency “unacceptable,” as a result of danger of falsely clearing sufferers who might unfold the an infection to others. They acknowledged shortcomings of the research, together with the time wanted to move affected person samples to the gadget for processing.

Abbott rejected the findings, saying the researchers used the take a look at “in ways in which it was not designed for use.”

U.S. President Donald Trump opens a field containing a five-minute take a look at for COVID-19 from Abbott Laboratories within the Rose Backyard of the White Home in Washington on this March 30 file photograph. (Alex Brandon/The Related Press)

“ID NOW is meant for use close to the affected person with a direct swab take a look at technique,” the corporate mentioned in an announcement. The corporate pointed to different impartial research outcomes that discovered the take a look at precisely detected 90 per cent or extra infections.

Final month Abbott modified the directions for its take a look at to explicitly warn in opposition to placing affected person samples in transport chemical compounds. The replace got here after researchers on the Cleveland Clinic reported a 15 per cent false destructive fee for samples saved within the chemical compounds.

The FDA mentioned in an announcement it’s reviewing the information with Abbott and dealing on a letter to well being care suppliers about potential accuracy points. The company mentioned physicians might have to substantiate the outcomes of a destructive Abbott take a look at if sufferers have indicators and signs of the virus.

Regulators mentioned they’re requiring Abbott to conduct follow-up research on the take a look at’s accuracy.

Trump promoted take a look at

“This take a look at can nonetheless be used and might accurately determine many optimistic circumstances in minutes,” mentioned Dr. Tim Stenzel, FDA’s diagnostics director.

The FDA first cleared Abbott’s take a look at in late March below emergency powers used to rapidly speed up the evaluate of assessments and coverings throughout a public well being disaster. The company has licensed greater than 90 assessments, successfully flooding the market with testing choices amid persistent issues ramping up testing ranges.

For weeks, Trump has promoted Abbott’s take a look at as a “recreation changer.” On Monday, the corporate’s ID NOW system and take a look at cartridges had been displayed prominently at a Rose Backyard press convention meant to focus on the nation’s progress on testing.

“These assessments are extremely subtle — very fast, superb,” Trump instructed reporters.

The administration has shipped greater than 235,000 of the assessments to state public well being laboratories. And Abbott has individually mentioned it has distributed 1.eight million assessments to well being care services in all 50 states.

A White Home spokesperson didn’t instantly reply to a request for remark Thursday night time.

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