Performance Issues With CDC’s COVID-19 Assay Reagent Slows Rollout Of Test Kits To US States
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.
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A rapid-response test from Danaher business unit Cepheid will be the first quick COVID-19 diagnostic to reach the US market, the US FDA announced on 21 March.
Only 12 US jurisdictions currently have sound COVID-19 virus assays from the Centers for Disease Control and Prevention to test suspected virus cases, CDC director Robert Redfield told a House panel looking at virus preparedness on Wednesday – but a better batch is coming, he said. Other questions raised at the congressional hearing was how long an infected person stays infected, whether COVID-19 can be picked up from inanimate surfaces, and related queries.
The US agency on 4 February issued its first Emergency Use Authorization of a 2019-novel coronavirus test by enabling emergency use of the Centers for Disease Control and Prevention’s 2019-nCoV Real-Time RT-PCR Diagnostic Panel. The move will allow use of the test at any CDC-qualified lab across the US.