HHS has launched an investigation into CDC’s first round of coronavirus diagnostic tests that many public health laboratories across the country were unable to use because one component was flawed.
The delay in testing capacity has slowed the U.S. response to the coronavirus, which public health experts say impeded the detection of what are now outbreaks in multiple states. Only this week is the pace of testing beginning to step up.
The situation with the CDC lab in Atlanta — apparently a manufacturing defect — has already spurred finger pointing between various federal health agencies and officials, who are all under intense scrutiny amid a major public health crisis. President Donald Trump has repeatedly tried to reassure the public — and the sinking stock market — that it’s under control.
It is unclear which senior health officials, at which agencies, knew about the CDC test problems and when they learned of them. HHS is convening a team of scientists from outside the CDC to investigate the test development and its flaws, according to an HHS spokesperson. HHS gave no further details Sunday night on who the experts are, or whether they included government as well as outside scientists.
Axios first reported the HHS investigation and said contamination involving the test component may have been the problem. An HHS official told POLITICO there was an problem with lab test cleanliness that affected the rollout of the coronavirus tests, but added that has been resolved. The official gave no further details.
It remains unclear why CDC developed its own coronavirus test, rather than relying on one distributed by the World Health Organization, but some experts suggest the agency wanted a test that would do a better job of ruling out other viruses.
FDA Commissioner Stephen Hahn said in a statement late Sunday that once FDA learned of the issue, it worked with CDC. The agencies agreed to drop the part of the test that was making verification difficult. The hope is that the modification will allow many more public health labs to start testing for the coronavirus. Some of them have already begun to test — and more Covid-19 cases are being detected.
“FDA has confidence in the design and current manufacturing of the test that already have and are continuing to be distributed,” Hahn said.
CDC did not respond to questions Sunday evening.