COVID-19HospitalsRegulatory

FDA probes Abbott’s rapid coronavirus test accuracy issues

May 15, 2020 / Associated Press

WASHINGTON – Federal health officials are alerting doctors to a potential accuracy problem with a rapid test for COVID-19 used at thousands of hospitals, clinics and testing sites across the U.S., including the White House.

The Food and Drug Administration said late Thursday it is investigating preliminary data suggesting Abbott Laboratories’ 15-minute test can miss COVID-19 cases, falsely clearing patients of infection. The test is used daily at the White House to test President Donald Trump and key members of his staff, including the coronavirus task force.

The warning came one day after researchers at New York University reported results suggesting Abbott’s test can miss up to half the infections caught by a rival test made by Cepheid. The research has not been peer-reviewed or published in a medical journal and was based on about 100 patients.

The researchers found that Abbott’s test, run on the company’s portable ID NOW system, missed one-third of the infections caught by Cepheid’s test when swabs were stored in liquid used to transport laboratory samples. When the samples were kept dry the test missed 48 percent of the cases flagged by Cepheid’s test.

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Chris J. Stewart

Chris currently serves as Chief Executive Officer of Surgio Health as well as COO at Ortho Spine Partners. Chris has close to 20 years of healthcare management experience with an infinity to improve healthcare delivery through the development and implementation of innovative solutions that solve real problems that result in improved efficiencies, reduction of unnecessary financial & clinical variation, and help drive better patient outcomes. Previously, Chris was assistant vice president and business unit leader for HPG/HCA. He has presented at numerous healthcare forums on topics that include disruptive innovation, physician engagement, shifting reimbursement models, cost per clinical episode and the future of supply chain delivery.

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