CDC's early COVID-19 tests had design flaw, internal review shows

COVID-19 testing kits the CDC developed in the pandemic's early weeks contained a design flaw that caused false positives, the agency concluded in a Dec. 15 analysis published in PLOS One.

The CDC previously disclosed that the polymerase chain reaction tests developed in January 2020 were contaminated but had not acknowledged the basic design flaw, according to The New York Times.

The faulty test kits were distributed to laboratories in early February 2020, with many reporting that the tests produced inconclusive results. Experts say the faulty tests hurt national efforts to detect and track COVID-19 cases. 

"It delayed the availability of more widespread testing," Benjamin Pinsky, MD, PhD, director of clinical virology at Palo Alto, Calif.-based Stanford Health Care, told the Times. "I think it's important that they got to the bottom of what went wrong."

CDC researchers said the agency has since improved quality control, quality assurance and test validation practices.


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