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.
You may also be interested in...
Tests may need to be pulled from the shelves if the COVID-19 Public Health Emergency isn’t renewed before it would expire this month, device lobby group AdvaMed claims. But HHS has indicated plans to renew the order.
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.