States that prohibit long-term care providers from using rapid, point-of-care antigen testing devices are in violation of federal law and could face serious consequences from public health authorities, a top official has warned.
The Department of Health and Human Services on Friday sent a letter to Nevada public health officials demanding that the state rescind its directive that called on long-term care facilities to immediately discontinue the use of COVID-19 antigen point-of-care antigen tests until further notice due to concerns about false positive results.
“Nevada’s letter unilaterally prohibiting these tests is in violation of HHS’ PREP Act guidance. Under federal law, Nevada may not prohibit or effectively prohibit such testing at congregate facilities,” HHS Assistant Secretary Admiral Brett Giroir told reporters Friday.
“While we absolutely welcome the opportunity to discuss any concerns with these two tests, or any other test, and to report them appropriately to the FDA for further evaluation, the Department of Health and Human Services will — as our letter clearly stipulates — take swift and appropriate steps to protect Nevada seniors if the state of Nevada does not immediately reverse it’s unwise, uniformed and unlawful unilateral prohibition,” he added.
Nevada over the weekend rescinded the statewide order following the federal government’s response. Giroir on Friday added that if Nevada wouldn’t have issued the directive in the first place, the federal government might have taken a behind-the-scenes approach to this issue.
“We feel very strongly that the prohibition is putting nursing homes in a terrible position,” Giroir said at the time. “We needed to get out in front of this, make sure it was clear that the prohibition was illegal, that nursing homes could proceed and that was the scientifically and technically right thing to do.”
3 in 5 false positive
As of last week, 65% of Nevada’s nursing homes had received more than 25,000 tests from either Quidel or Becton Dickinson through the federal government’s point-of-care testing program, which was first announced in July, according to Giroir.
The state said it received reports from SNFs in mid-September that the devices were producing false positives. When it investigated the issue among 12 facilities, Nevada officials said it found that 40% of tests were found to be true positives and 60% were false positives.
Giroir noted that some false positives are expected with every type of test. He added that the federal government recommends a “layered approach with rapid, inexpensive, frequent point-of-care tests on the frontline verified by more expensive, sophisticated and longer turnaround tests according to the clinical situation.”
“Bottom line, the recommendations in the Nevada letter are unjustified and not scientifically valid. They must cease their prohibition immediately,” Giroir said on Friday. “I encourage all nursing homes in Nevada and throughout the country to adhere to [Centers for Medicare & Medicaid Services’] standards for testing your staff, and if you need to use point-of-care antigen tests to do that, you should proceed.”