At a time when the Trump administration has been heavily criticized for not providing coronavirus testing to millions of nervous Americans, a federal health official's comments on Tuesday indicated that the World Health Organization's diagnostic tests were extremely inaccurate.
In a somewhat extensive answer to a question related to W.H.O. Dr. Deborah Birx, the Coronavirus response coordinator at the White House, said: "It doesn't help to run a test that 50 percent or 47 percent were false positives. Imagine what that would mean for the American people. Imagine yourself before what that would mean to tell someone that he was positive when he wasn’t. "
It was not clear where Dr. Birx had these numbers, but obviously such an inaccurate test would be worthless. Late Tuesday evening Dr. Birx that she answered a question about W.H.O. Test referred to a study of an early diagnostic test that was used in China.
The paper found that in a certain subset of people tested in China – asymptomatic contacts in known cases – the tests were wrongly positive in 47 percent of the cases.
However, there were no suggestions that the W.H.O. The test, which is sold worldwide, has significant accuracy problems. On Tuesday evening, Dr. Birx, she didn't go to the W.H.O. Test, "but I assume it's working."
Dr. Birx was asked several questions by reporters about the lack of tests during the press conference and came and went to the microphone several times.
She was asked a question early on that the government struggled with: if federal officials sent millions of tests, as White House officials have said several times, why were only 60,000 Americans tested?
Dr. Birx replied that tests in the United States are now being carried out by many manufacturers, which is correct. Different diagnostic tests are now being performed by state laboratories, medical school laboratories, and private companies such as Thermo Fisher, which she cited as an example.
Dr. Birx said she urged commercial vendors to get their tests out, but of course they first had to prove to the Food and Drug Administration that they were high quality.
She was later asked for a criticism from former Vice President Joseph R. Biden Jr. in Monday 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 W.H.O. Tests at all, but said, "We don't buy tests that are not quality controlled and they show us the data." Then he added that a test with high inaccuracy rates would be a disaster.
imageRecognition…Kamran Jebreili / Associated Press
A spokeswoman for the W.H.O. said she didn't know what Dr. Birx received, but the agency had delivered kits to member states since January.
The accuracy of the test was validated by three laboratories prior to its launch, the spokeswoman said, and he had consistently “performed well in the laboratory and in clinical use, and no significant number of false positives or false negatives were reported. ”
In any case, Mr. Biden's claim that the Trump administration approved the W.H.O. seems to be wrong. The W.H.O. does not sell tests to wealthy countries that usually prefer to do their own.
Dr. Anne Schuchat, deputy chief director of the Centers for Disease Control and Prevention, confirmed that the W.H.O. gave test kits "mainly to underserved countries". Another official, who spoke on condition of anonymity, confirmed that the W.H.O. had never offered to sell or test the United States.
China, Hong Kong, France, Germany, Thailand and the United States have, according to W.H.O. Website. Everyone is looking for two or three short sections of viral genes.
For example, the C.D.C.test examines three targets of the N gene, while those from the W.H.O. Look at parts of the N gene, the RdRP gene and the E gene. Each gene has a different function in helping the virus enter cells, hijack their DNA machinery, and reproduce millions of copies of themselves.
For countries that cannot perform the tests or cannot buy in other countries, the W.H.O. asks academic or government laboratories to conduct tests.
It then delivers them to low and middle income countries at low or no cost and pays them from emergency funds or loans from institutions such as the World Bank.
The W.H.O. was in a laboratory by Dr. Christian Drosten at the medical faculty of the Berlin Charity Hospital, which is considered one of the world's best genome laboratories.
In an email from February 21, another W.H.O. The spokesman said the accuracy of the test had been checked by three other laboratories before being sent to a German diagnostic company for production. There were no problems with the first delivery of 250,000 cans, he said.
Dr. Michael Mina, 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. The test was attributed to errors in the manufacture of reagents for kits, not to the design of the C.D.C.
No test is 100 percent accurate, but the errors are usually caused by medical personnel who do not take the samples correctly, or by laboratory personnel who incorrectly perform the test or accidentally contaminate it with stray DNA.
For example, in February, an American passenger released from the cruise ship Westerdam, which sailed from port to port for many days before Cambodia landed, was tested positive for the virus while traveling through Malaysia and triggered a crisis.
The C.D.C. She later said she did not have the virus and judged the Malaysian test to be likely false positive.
Since Malaysia did not have its own test, it probably used the W.H.O. However, Malaysia does not have a top quality laboratory and many laboratories make initial mistakes when launching a new test.
Sheri Fink and Ellen Gabler reported from New York. Abby Goodnough reported from Washington.