The head of statewide coronavirus testing efforts on Friday condemned the Nevada Health Department for ordering nursing homes to stop two government-issued brands of rapid coronavirus tests that the state had found inaccurate.
"The bottom line is that the recommendations in the Nevada letter are unwarranted and scientifically invalid," said Adm. Brett Giroir, Assistant Secretary for Health and Human Services, on a call with reporters on Friday. The actions of the state are "unwise, uninformed and unlawful" and could lead to unspecified rapid punitive measures in the federal government if they are not reversed.
The rapid tests, distributed by the federal government to nursing homes across the country in August, were intended to address the months of delays and equipment shortages that had hampered laboratory testing.
"The important issue is the safety of the elderly," said Admiral Giroir in an interview on Friday. Antigen tests are "life-saving tools" that some nursing home representatives have called a "stroke of luck". According to an analysis by the New York Times, around 40 percent of the country's known Covid-19 deaths come from nursing homes.
But Nevada officials had detected false positives rashes on two types of rapid tests manufactured by Quidel and Becton, Dickinson and Company and used in the state's nursing homes. Both tests look for antigens or parts of coronavirus proteins and were not advertised as false positive results.
Of a sample of 39 positive test results collected in nursing homes across the state, 23 were found to be false positives, the state reported. (The bulletin did not state whether antigen test results, of which there were thousands, were confirmed negative, so the number of false negative results remained unknown.)
"I would consider that to be a significant number of false positives," said Omai Garner, a clinical microbiologist at the University of California at Los Angeles.
Admiral Giroir claimed that such false alarm rates were to be expected and "indeed an excellent result". No test is perfect, he said.
He also said the federal government was expecting the state to immediately lift its unilateral ban, which it cited as a violation of the Public Preparedness and Emergency Preparedness Act.
A guide from Admiral Giroir's office dated August 31 stipulated that reporting under the PREP Act "prevents" the use of coronavirus tests approved by the Food and Drug Administration for individuals in gathering environments such as care facilities.
What Nevada has done is "illegal," he said. "You cannot replace the PREP law."
In the federal government's formal October 8 response to the Nevada Health Department, signed by Admiral Giroir, state officials were portrayed as scientifically incompetent and their actions "inappropriate" 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," wrote Admiral Giroir.
Should the state assert itself, "there may be penalties from the federal government," he said in an interview on Friday, but declined to give details.
The Nevada health authorities did not respond to a request for comment. Both BD and Quidel made statements that they were satisfied with Admiral Giroir's response and reiterated their confidence in the performance of their products.
Jennifer Nuzzo, a public health expert at Johns Hopkins University, described Giroir's letter to Nevada as "unprecedented in my opinion".
"I've never seen anything like it in my life," said Susan Butler-Wu, a clinical microbiologist at the University of Southern California. Nevada, she said, "found on the spot that it was causing them too many problems." And they stopped and stopped. "
Tom Bollyky, director of the global health program and senior fellow on global health, business and development at the Council on Foreign Relations, said Nevada could have legal grounds to oppose the federal government.
"They have legitimate concerns about the accuracy of the test," he said, noting that the mandate for certain types of tests was not what the law was written for: "It should provide immunity to vaccine and drug claims."
However, should the matter lead to litigation or similar action from other states, care institutions could find themselves in the middle of a tense dispute.
"The need to manage the differences between federal and state mandates in testing – a crucial tactic – is another burden at an already challenging time," said Ruth Katz, senior vice president of policy for LeadingAge, an association of nonprofit providers of aging services.
Mr. Bollyky also noted that he was impressed with the "sour" tone of the letter. "This goes without saying for 2020, but I can't remember the last time I received a letter like this before 2020 from an H.H.S. official from the state health department," he said.
"I didn't mean to be disrespectful," Admiral Giroir replied to questions about the tone of the letter to Nevada state officials. However, he hoped the wording would send a clear and far-reaching message that the federal government's testing policy, which he insists on 100 percent scientific support, should not be underestimated.
"I wanted to be clear to everyone, not just Nevada," he said, adding, "I think your decision is wrong."