C.D.C. Virus Tests Were Contaminated and Poorly Designed, Agency Says

The faulty coronavirus testing kits developed by the Centers for Disease Control and Prevention in the early weeks of the pandemic were not only contaminated but had a basic design flaw, according to an internal review by the agency. Health officials had already acknowledged that the test kits were contaminated, but the internal report … also documented a design error that caused false positives. In January 2020, the C.D.C. developed a polymerase chain reaction, or P.C.R., test for the virus. P.C.R. tests, which are performed in laboratories, can detect the virus at very low levels. Problems emerged soon after the C.D.C. had begun shipping its test kits out to public health laboratories in early February. Within days, many labs were reporting that the tests were generating inconclusive results. In mid-February, the agency acknowledged that the kits were flawed, and in April, officials at the U.S. Food and Drug Administration said that poor manufacturing practices had resulted in contamination of the test kits. Test kits had been contaminated with synthetic fragments of the virus’s genetic material. These synthetic sequences … were manufactured at the same C.D.C. lab where the test kits were undergoing a quality analysis. It is “likely” that the test kits were contaminated there, the agency concluded. The contamination suggests that the agency violated standard manufacturing protocols. Rather than relying on the C.D.C. to be the sole test developer, officials could also enlist clinical and commercial labs to create and deploy tests.

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Author: {Want To Know}

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