Faulty CDC COVID-19 Assays Leave Only 12 US Jurisdictions With Testing Ability, CDC Director Says
But better reagent coming, Robert Redfield tells congressional panel
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.
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The US FDA on 29 February issued a new guidance giving the OK to labs with pending COVID-19 laboratory-developed tests (LDTs) to use them while they await the agency’s approval under Emergency Use Authorization. The agency issued the guidance quickly, taking the unusual step of forgoing a public comment period.
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.
FDA Open To Home COVID-19 Testing With Caveats, OIVD’s Stenzel Says; Grants First Serology Test EUA To BD
The US FDA is open to the idea of home-testing for the COVID-19 virus, but only after making sure the test is completely safe and effective, and available only through a physician’s oversight, said Tim Stenzel, director of the agency’s Office of In Vitro Diagnostics and Radiological Health. Stenzel also heralded the FDA’s first emergency use authorization for a coronavirus serology test, which was granted to diagnostic developer Becton Dickinson.