Federal health officials have ordered Nevada to allow nursing homes to use two rapid antigen tests after a review showed a majority of positive results were false, saying the action violated federal law and endangered lives.
Nevada's Department of Health and Human Services banned Quidel Corp.'s Sofe and Becton Dickinson and Co.'s Veritor antigen tests from long-term care facilities after receiving anecdotal reports questioning their validity. Those point-of-care tests' positive results contradicted negative readings from reverse-transcriptase polymerase chain reaction tests, which are considered more accurate.
HHS Assistant Secretary Dr. Brett Giroir on Friday said the agency would take "swift and appropriate steps" if Nevada's Department of Health and Human Services didn't reverse course.
"The letter from Nevada officials can only be interpreted as reflecting a fundamental lack of basic knowledge about testing and interpreting results," Giroir said. "Not just COVID testing but clinical testing in general."
Nevada's agency said spot checks of antigen tests found that only 40% were considered true positives; 23 of the 39 tests reviewed were false positives. Twelve skilled-nursing facilities performed more than 3,700 antigen tests with 60 positive results.
The state reported that Becton Dickinson tests had a 50% accuracy rate, and only one of the nine reviewed Quidel tests was a true positive.
"If the use of the outlined antigen tests continues within a SNF, the Bureau of Health Care Quality and Compliance will take necessary corrective action to ensure the safety of staff and residents within the facility," state health officials wrote to nursing homes.
The conflicting tests results may have stemmed from inadequate training, complpiance issues or false negatives from the RT-PCR tests, according to state health official. Nevada said it would update its antigen testing guidance after it received more data.
Giroir said all tests are expected to have some false positives, especially when screening a patients with a low infection prevalence. Nevada has reported 84,593 confirmed cases as of Friday, with 766 new cases over the last day.
Across the country, nearly 246,000 nursing home residents have tested positive for COVID-19, with another 141,444 suspected cases, according to CMS.
In August, CMS started requiring long-term care facilities to routinely screen both residents and staff for COVID-19 or face financial penalties. The agency hoped the effort would help stem coronavirus outbreaks in nursing homes.
Giroir declined to elaborate on the actions HHS could take if Nevada health officials don't comply with the demand, but noted there were several enforcement mechanisms at their discretion. He said he was confident they would comply after reviewing the facts.
"There really is no scientific reason, no medical reason to not comply with this and not to allow lifesaving testing," Giroir said.
