Did Federal Officials Really Question W.H.O. Tests for Coronavirus?

Dr. Birx answered that tests in the United States were now being made by many producers, which is correct. Differing diagnostic tests are now made by state laboratories, medical school laboratories and private companies like Thermo Fisher, which she mentioned as an example.

Dr. Birx said she was strongly urging commercial providers to get their tests out, but of course, they first had to prove to the Food and Drug Administration that they were of high quality.

Later, she was asked about a criticism made by Mr. Biden in Monday’s night’s debate. He said the W.H.O. had “offered tests to the United States but we didn’t buy them.”

In her answer, she did not refer to the W.H.O. tests at all, but said, “We don’t buy tests that haven’t been quality-controlled and they show us the data," then adding that a test that with high rates of inaccuracy would be a disaster.

A spokeswoman for the W.H.O. said she did not know what Dr. Birx was referring to, but the agency had been supplying kits to member nations since January.

The accuracy of the test was validated by three laboratories before it was rolled out, the spokeswoman said, and it had consistently showed “good performance in laboratory and clinical use, and neither a significant number of false positive nor false negative results have been reported.”

In any case, Mr. Biden’s assertion that the Trump administration refused tests offered by the W.H.O. appears to be wrong. The W.H.O. does not sell tests to wealthy countries, which usually prefer to make their own.

Dr. Anne Schuchat, deputy principal director of the Centers for Disease Control and Prevention, confirmed that the W.H.O. gave test kits “primarily to underresourced countries.” Another administration official, speaking on the condition of anonymity, confirmed that the W.H.O. had never offered to sell or give tests to the United States.

China, Hong Kong, France, Germany, Thailand and the United States have all designed their own tests, according to the W.H.O. website. Each one looks for the presence of two or three short stretches of viral genes.

For example, the C.D.C’s test looks at three targets on the N gene, while Dr. Christian Drosten’s looks at bits of the N gene, the RdRP gene and the E gene. Each gene performs a different function in helping the virus break into cells, hijack their DNA machinery and reproduce million of copies of itself.

For countries that are unable to make the tests or buy them from other countries, the W.H.O. asks academic or government laboratories to make tests.

It then delivers them to poor and middle-income countries at low or no cost, paying for them out of emergency funds or loans from institutions like the World Bank.

The test ordered by the W.H.O. was designed in a lab run by Dr. Drosten at the medical school of Berlin’s Charity Hospital, which is considered one of the world’s top genomic laboratories.

According to a detailed description of the test posted on the W.H.O. website, in its initial rollout, it was accurate 100 percent of the time.

In a Feb. 21 email, another W.H.O. spokesman said the test’s accuracy had been verified by three other laboratories before it was sent to a German diagnostics company for manufacturing. There had been no problems with the first shipment of 250,000 doses, he said.

Dr. Michael Mina, an assistant professor of epidemiology at the Harvard School of Public Health, said both the W.H.O. test and the initial C.D.C. tests were “exceptional” in their accuracy.

The problems with the C.D.C. test have been attributed to flaws in the manufacturing of reagents for kits, not in the C.D.C.’s design.

No test is accurate 100 percent of the time, but the errors are usually introduced by medical personnel who fail to take samples correctly or lab personnel who run the test incorrectly or accidentally contaminate it with stray DNA.

For example, in February an American passenger released from the cruise ship Westerdam, which went from port to port for many days before Cambodia allowed it to dock, tested positive for the virus as she passed through Malaysia, setting off a crisis.

The C.D.C. later said she did not have the virus and judged the Malaysian test to be a likely false positive.

Since Malaysia did not have its own test, it presumably used the W.H.O.’s. But Malaysia does not have a top-quality lab, and many labs make initial errors when they are rolling out a new test.

Sheri Fink and Ellen Gabler contributed reporting from New York. Abby Goodnough contributed reporting from Washington.

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As Coronavirus Testing Increases, Some Labs Fear a Shortage of Other Supplies

At the University of California, Los Angeles, the chief of the microbiology section of the medical center’s clinical lab was so concerned about his supply of RNA extraction kits made by the company Qiagen that he recently sent an email to colleagues at the university’s research labs asking if they had any. “While our investigators were eager to help, none were using the kit in their labs,” said Elaine Schmidt, a spokeswoman for the medical center.

Eric Blank, the chief program officer at the Association of Public Health Laboratories, said his group has also been hearing about back orders of the extraction kits and other supplies. Now that independent labs are able to run their own tests, “it is increasing at a very rapid pace,” Mr. Blank said. “It just depends on how rapidly the manufacturers of some of these other ancillary materials needed to run the tests can ramp up their production.”

Qiagen, a major manufacturer of the RNA extraction kits, said in a statement this week that because of the coronavirus outbreak, demand is “challenging our capacity to supply certain products” and that it was increasing production in sites in Germany, Spain and Maryland.

Roche, another supplier of lab materials and equipment, said in a statement: “Our manufacturing network has robust business continuity plans for dealing with the impact of a potential health crisis and is actively assessing and monitoring this evolving health situation.”

The F.D.A. and C.D.C. have also said they are watching for potential shortages. The F.D.A. said this week it was “monitoring this issue and has heard from some manufacturers with questions about alternative reagents, extraction methods and platforms.” It said it was offering guidance to labs and updates on the issue on its website.

But the extraction kits are not the only supply item with uncertain availability. The American Society for Microbiologists said Tuesday that it was “deeply concerned” about a potential shortage of the reagents needed to conduct the tests as well as other materials. “Increased demand for testing has the potential to exhaust supplies needed to perform the testing itself,” the society said.

On Monday, the C.D.C. revised its guidelines to allow for the collection of one specimen swab instead of the previously required two, a move that the society said would cut the required amount of testing reagents in half.

Dr. Robert Redfield, the director of the C.D.C., told Politico on Tuesday that the agency was keeping an eye on the supply of materials needed to do the tests. But, when asked how the agency would deal with a shortage of RNA extraction kits, he said: “I don’t know the answer to that question.”

Integrated DNA Technologies, which is manufacturing coronavirus test kits for the C.D.C., said in a statement that beginning next week, it expects to be able to provide enough shipments of C.D.C. kits that would allow for five million tests a week. The company added that “is accustomed to scaling up to meet customer demand and does not anticipate needing to hire additional staff.”

Labs have also said they have had a difficult time getting so-called positive controls, or samples of the virus to ensure the tests are working properly.

“We have requested these from a couple of vendors, but it has taken some time to get registered to have the controls shipped,” said Dr. Jim Dunn, the director of medical microbiology and virology at Texas Children’s Hospital in Houston, which is now running its own test for coronavirus for the hospital’s patients.

Veronique Greenwood and Denise Grady contributed reporting.

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