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Performance Issues With CDC’s COVID-19 Assay Reagent Slows Rollout Of Test Kits To US States

 
• By Sue Darcey

A reagent in a batch of COVID-19 tests shipped by the US Centers for Disease Control and Prevention to state laboratories “wasn’t performing consistently,” a top CDC official says, so the agency is reformulating it – slowing down the labs’ ability to use the diagnostic, which yielded inconsistent results when quality-tested. But waiting in the wings are commercial coronavirus test kits being developed by Qiagen and Cepheid; both firms say they’ll submit the kits to the FDA for emergency-use approval.

Nurse holding test tube with blood for 2019-nCoV analyzing. Novel Chinese Coronavirus blood test Concept.

A top Centers for Disease Control and Prevention official says some US state laboratories have reported quality-control glitches with CDC test kits they’ve received and need to detect coronavirus infections.

The kits were shipped to all 50 US state laboratories earlier this month, shortly after they were granted Emergency Use...

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• By Natasha Barrow

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• By Elizabeth Orr

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More from Policy & Regulation

FDA’s AI Tool Won’t Make Regulatory Decisions, Official Says

 
• By Cathy Kelly

Tala Fakhouri said the agency’s use of the AI tool in the review process has generated lots of questions.

MHRA Opens Second AI Airlock Program For Applications

 
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• By Brian Bossetta

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