Abbotts

As Problems Grow With Abbott’s Fast COVID Test, FDA Standards Are Under Fire

In mid-May, the Food and Drug Administration issued a rare public warning about an Abbott Laboratories COVID-19 test that for weeks had received high praise from the White House because of its speed: Test results could be wrong.

The agency at that point had received 15 “adverse event reports” about Abbott’s ID NOW rapid COVID test suggesting that infected patients were wrongly told they did not have the coronavirus, which had led to the deaths of tens of thousands of Americans. The warning followed multiple academic studies showing higher “false negative” rates from the Abbott device, including one from New York University researchers who found it missed close to half of the positive samples detected by a rival company’s test.

But then, in a move that confounded lab officials and other public health experts, a senior FDA official later that month said coronavirus tests provided outside lab settings would be

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Abbott’s Fast COVID Test Poses Safety Issues, Lab Workers Say

Lab personnel say worries are mounting over the safety of a rapid coronavirus test by Abbott Laboratories that President Donald Trump has repeatedly lauded ― particularly, the risk of infection to those handling it.

Trump and federal health officials have promoted the ease with which the Abbott test can be given to patients, whether at a drive-thru site or a doctor’s office. Another selling point: The test could “save personal protective equipment (PPE),” according to the Department of Health and Human Services.

Yet medical workers say that there’s a serious danger in the test’s design, one that would require much more protection — not less ― for those who administer it.

Running a test involves swabbing a potentially infected person’s nasal passage and swirling the specimen in an open container with liquid chemicals, raising the potential of releasing the highly contagious virus into the air.

When HHS announced it had

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Trump Touted Abbott’s Quick COVID-19 Test. HHS Document Shows Only 5,500 Are On Way For Entire U.S.

A coronavirus test made by Abbott Laboratories and introduced with considerable fanfare by President Donald Trump in a Rose Garden news conference this week is giving state and local health officials very little added capacity to perform speedy tests needed to control the COVID-19 pandemic.

“That’s a whole new ballgame,” Trump said. “I want to thank Abbott Labs for the incredible work they’ve done. They’ve been working around-the-clock.”

Yet a document circulated among officials at the Department of Health and Human Services and the Federal Emergency Management Agency this week shows that state and local public health labs were set to receive a total of only 5,500 coronavirus tests from the giant manufacturer of medical devices, diagnostics and drugs, according to emails obtained by Kaiser Health News.

That number falls well short of the “about 500,000 capacity of Abbott tests that” Dr. Deborah Birx, the White House coronavirus response coordinator,

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