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Health Canada authorizes Abbott COVID-19 antibody test

Abbott (NYSE:ABT) announced today that Health Canada has granted interim authorization for its Architect SARS-CoV-2 IgG serology test for COVID-19.

The Abbott Park, Ill.-based company won an FDA emergency use authorization and the CE Mark for the same antibody test for use on its Architect system in April. The test is designed to detect the IgG antibody, a protein that the body produces in the late stages of infection and may remain up to months after a person has recovered from the novel coronavirus.

A recent study published in the Journal of Clinical Microbiology found that Abbott’s SARS-CoV-2 IgG antibody test had 99.9% specificity and 100% sensitivity for detecting the IgG antibody in patients 17 days or more after symptoms began. Abbott has come under scrutiny for the accuracy of one of its COVID-19 molecular diagnostic tests.

The company said it expects to begin shipping antibody tests to Canada this week and intends to distribute 30 million …

What medtech’s top CEOs are saying about COVID-19

The COVID-19 pandemic is drying up sales for many large medical device companies, but there’s hope for a recovery later this year.

That’s the big message from medtech’s top CEOs as they issue financial predictions and engage in earnings calls with analysts.

Governments around the world are calling on medical device companies to make the supplies that health providers need to manage the virus: respirator masks, ventilators, infusion pumps, virus and antibody tests, and more.

At the same time, the same companies are taking a hit related to the devices and products used in elective procedures — and even procedures that people actually need — as hospitals focus on saving people with COVID-19.

It’s little wonder then that MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — remains down about 10% from its pre-pandemic Feb. 19 high point. (It’s still in better shape than the Dow Jones Industrial Averag…

FDA warns on accuracy of Abbott rapid COVID-19 test

Abbott’s ID Now test machine (Image from Abbott)

After weeks of concerns about the accuracy of an Abbott (NYSE:ABT) rapid COVID-19 diagnostic test, the FDA last night issued a warning that the ID NOW test may return false-negative results.

Citing “early data,” the agency said it is “sharing early information … about potential inaccurate results in the spirit of transparency.”

A preliminary study released this week by researchers at New York University found that the test missed up to 48% of positive results. Researchers at the Cleveland Clinic reported in April that the ID NOW had a false-negative rate of 14.8%, according to a report by National Public Radio.

One issue is the treatment of specimens before they are placed in the ID NOW machine. Abbott advised customers on April 15 that placing specimens in liquid viral transport media before processing — stan…