Home 5 Articles 5 CDC Knowingly Sent Flawed COVID-19 Test Kits to Public Laboratories in Early Days of Crisis

CDC Knowingly Sent Flawed COVID-19 Test Kits to Public Laboratories in Early Days of Crisis

by | Nov 24, 2020 | Articles, Clinical Diagnostic Insider, Diagnostic Testing and Emerging Technologies, Emerging Tests-dtet, Top of the News-dtet

Early missteps characterized the federal government’s initial efforts to ensure a supply of reliable COVID-19 diagnostic tests in response to the public health emergency. And now a new National Public Radio (NPR) report contends that the U.S. Centers for Disease Control and Prevention (CDC) deliberately sent test kits to public labs despite knowing that they were apt to fail to 33 percent of the time. The CDC’s Decision The Nov. 6 report’s conclusion is based on a “root-cause analysis” internal review that the CDC conducted to understand why its early real-time reverse transcription polymerase chain reaction RT PCR coronavirus test did not function properly, costing scientists and public health officials precious weeks in the early days of a pandemic. The CDC test, the first to receive Food and Drug Administration emergency use authorization for COVID-19, was designed and built in record time. According to NPR, the tests were all boxed up and ready to go on Feb. 6 when a scientist in an infectious disease laboratory on the CDC’s Atlanta campus discovered the high failure rate while putting the test kit through its final paces. A failure rate of that magnitude would have normally precluded releasing the test. But the […]

Early missteps characterized the federal government’s initial efforts to ensure a supply of reliable COVID-19 diagnostic tests in response to the public health emergency. And now a new National Public Radio (NPR) report contends that the U.S. Centers for Disease Control and Prevention (CDC) deliberately sent test kits to public labs despite knowing that they were apt to fail to 33 percent of the time. The CDC’s Decision The Nov. 6 report’s conclusion is based on a “root-cause analysis” internal review that the CDC conducted to understand why its early real-time reverse transcription polymerase chain reaction RT PCR coronavirus test did not function properly, costing scientists and public health officials precious weeks in the early days of a pandemic. The CDC test, the first to receive Food and Drug Administration emergency use authorization for COVID-19, was designed and built in record time. According to NPR, the tests were all boxed up and ready to go on Feb. 6 when a scientist in an infectious disease laboratory on the CDC’s Atlanta campus discovered the high failure rate while putting the test kit through its final paces. A failure rate of that magnitude would have normally precluded releasing the test. But the CDC apparently caved in to the intense pressure and proceeded to distribute the test to about 100 public laboratories across the country, including the New York City Public Health Laboratory. Problems with the CDC Laboratory The CDC’s deliberate decision to release a flawed test kit was not the only troubling finding of the root-cause analysis. The reviewers also determined that the CDC’s Respiratory Viruses Diagnostic Laboratory was beset with problems, including “process failures, a lack of appropriate recognized laboratory quality standards, and organizational problems related to the support and management of a laboratory supporting an outbreak response.” The problems with the Respiratory Viruses Diagnostic Laboratory were reported last month by ProPublica. NPR’s story is the first time the CDC internal review's findings have been made public. The CDC declined to discuss the review with NPR. Takeaway The decision of the CDC to rush an unproven if not faulty COVID-19 test kit to public laboratories in response to enormous public pressure is a cautionary tale that the agency and other scientific authorities will have to bear in mind when releasing a vaccine for the virus.

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