The leader of the nation’s coronavirus testing efforts condemned Nevada’s health department on Friday for ordering nursing homes to discontinue two brands of government-issued rapid coronavirus tests that the state had found to be inaccurate.
“Bottom line, the recommendations in the Nevada letter are unjustified and not scientifically valid,” Adm. Brett Giroir, an assistant secretary of Health and Human Services, said in a call with reporters on Friday. The state’s actions, he said, were “unwise, uninformed and unlawful” and could provoke unspecified swift punitive action from the federal government if not reversed.
The rapid tests, which were distributed to nursing homes around the country in August by the federal government, were supposed to address the months of delays and equipment shortages that had stymied laboratory-based tests.
“The important issue is to keep seniors safe,” Admiral Giroir said in an interview on Friday. Antigen tests, he added, were “lifesaving instruments” that had been called “godsends” by some nursing home representatives. About 40 percent of the country’s known Covid-19 deaths came from nursing homes, according to a New York Times analysis.
But Nevada officials had discovered a rash of false positives among two types of rapid tests, manufactured by Quidel and Becton, Dickinson and Company, that had been used in the state’s nursing homes. Both tests look for antigens, or bits of coronavirus proteins, and had been advertised as producing no false positives.
Among a sample of 39 positive test results collected from nursing homes across the state, 23 turned out to be false positives, the state reported. (The bulletin did not specify whether negative results from the antigen tests, of which there were thousands, had been confirmed, leaving the number of false negatives unknown.)
“I would consider that to be a significant number of false positives,” said Omai Garner, a clinical microbiologist at the University of California, Los Angeles.
Admiral Giroir contended that such rates of false positives are to be expected, and are “actually an outstanding result.” No test is perfect, he said.
He also said that the federal government expected the state to promptly rescind its unilateral prohibition, which he described as a violation of the Public Readiness and Emergency Preparedness Act.
An Aug. 31 guidance from Admiral Giroir’s office stipulated that PREP Act coverage “preempts” states from blocking the use of coronavirus tests that have been authorized by the Food and Drug Administration on people in congregate settings, like nursing facilities.
What Nevada has done is “illegal,” he said. “They cannot supersede the PREP Act.”
The federal government’s formal response to Nevada’s health department, dated Oct. 8 and signed by Admiral Giroir, portrayed the state’s officials as scientifically incompetent and their actions as “improper” under federal law. “Your letter can only be based on a lack of knowledge or bias, and will endanger the lives of our most vulnerable,” Admiral Giroir wrote.
Should the state hold its ground, “there can be penalties from the federal side,” he said in an interview on Friday, but declined to provide details.