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Sent Out Anyway

US Centers for Disease Control and Prevention officials were aware of problems with its initial SARS-CoV-2 test before the test was released, according to NPR.

As 360Dx reported in February, state laboratories ran into problems when they sought to validate the CDC's initial SARS-CoV-2 test kit. Because of this, the agency said it had to re-manufacture one of the kit's reagents. The kit was fixed by the end of February, but delayed testing in the US in the early stages of the pandemic.

NPR has now reviewed internal documents from the CDC that indicate that the problem was wider than the contamination of a reagent. According to NPR, a review of the Respiratory Viruses Diagnostic Laboratory found a number of problems, such as "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."

In particular, it reports that a quality control test of the kit before it was shipped out indicated that the test could fail about a third of the time, but that Stephen Lindstrom, the head of the lab who had success creating an H1N1 influenza test, decided to send the kit out anyway.

NPR adds that the CDC review includes recommendations to prevent such failures from occurring again — such as setting criteria for test kits must meet before being released and having an outside group review test. It further notes that Lindstrom is no longer running that lab and that the Department of Health and Human Services inspector general is conducting a separate review of the failed test.

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