US Agency Probes Defect in Faulty Coronavirus Test Kits

March 2, 2020 Updated: March 2, 2020
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The first testing kits for COVID-19 included a defect that contributed to weeks of delay in rolling out wider testing for the illness. The Department of Health and Human Services is looking into it.

The Centers for Disease Control and Prevention (CDC) manufactured the kits earlier this year and sent them to public health laboratories in all 50 states on Feb. 5. But some of the labs found inconclusive results being reported for specimens while validating the tests, causing all but a few states to wait until late February to test locally for samples.

Stephen Hahn, commissioner of the Food and Drug Administration (FDA), part of the Department of Health and Human Services, said investigators with his agency and the CDC found issues with some of the items comprising the kits.

The issues were resolved, enabling labs to use two of the three steps in the original kits to test samples for the new virus. Updated tests were sent out over the weekend and into this week.

“FDA has confidence in the design and current manufacturing of the test that we already have and are continuing to be distributed. These tests have passed extensive quality control procedures and will provide the high-level of diagnostic accuracy we need during this coronavirus outbreak,” Hahn said in a statement to news outlets.

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Swab samples in a coronavirus testing laboratory in Scotland on Feb. 19, 2020. (Jane Barlow – WPA Pool/Getty Images)

The department has opened a probe into the manufacturing flaw and is assembling a team of non-CDC scientists “to better understand the nature and source of the manufacturing defect,” it said in a statement.

Hahn was to attend a press briefing on March 2, but it was postponed, with no reason given.

The original test had “three different nucleic acid pieces. And one of them had a control … and in that control, there was low-level contamination,” Dr. Robert Redfield, director of the CDC, told lawmakers last week.

“There was never any question about whether the test could tell positive or negative. It just had a group of individuals that we had to say ‘we didn’t know,'” he said.

Testing was done by some state and local labs starting Feb. 28. A slew of new cases have been reported since then, including 15 in Washington state. The country’s first two deaths from the virus, both in the state, were also confirmed through local testing.

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A worker shields a patient on a stretcher being taken to an ambulance at the Life Care Center of Kirkland in Washington state on Feb. 29, 2020. (David Ryder/Getty Images)

At least 23 cases in total were reported over the weekend. The number of cases around the country rose to 91 by morning on March 2.

Secretary of Health and Human Services Alex Azar said on March 1 that officials expect additional cases in the United States.

“We’re ramping up testing. You know, we now have 75,000 tests available out there in the United States. And over the next week, that will expand radically on top of 75,000 tests available,” he said during an appearance on ABC’s “This Week.”

Officials, he said, “don’t know where this will go.” How big the outbreak becomes, he said, is also not known.

“But we have the most advanced public health system and surveillance system in the world. We are actively working on a vaccine. We are actively working on therapeutics. The diagnostic is out in the field,” he said. “And we’re going to work to protect the American people with every tool that we’ve got.”

Follow Zachary on Twitter: @zackstieber