Kristen Cardillo, vice president of global communications for BD, said the company is aware of the situation in Nevada and is "conducting a thorough investigation." She added, "Based on the information in the guideline and the overall testing performed, we believe the rate of false positives reported is well within what we would expect for the BD Veritor System."
Representatives from the Ministry of Health and Human Services did not respond to requests for comment.
Concerns have also been raised about the ability of antigen tests to pinpoint infections, especially when given during a period when a person has low levels of coronavirus. A false negative rate of 16 percent is given for the BD test. Quidels is just over 3 percent. The Nevada Department of Health guideline did not report whether the negative antigen test results from nursing homes – there were nearly 3,700 such results – were reported by P.C.R.
In a call to LeadingAge members on Monday, Adm. Brett Giroir, who led the country's testing efforts that antigen testing was "clearly a life-saving option" and the best test available for many facilities given the delays, costs and bottlenecks that had plagued PCR tests.
"It is perfectly acceptable for community carers, especially nursing homes, to use an antigen test, even if it is off-label," said Dr. Interview with Giroir. "Just because they don't have authorization doesn't mean they're not good for it."
In answering questions about false positives, Dr. Giroir reminded LeadingAge members that in places where coronavirus is rare, false positives would be expected to exceed the number of positive positives and not necessarily invalidate the usefulness of a test. "It's a function of life," said Dr. Giroir.
The suspension of antigen testing in Nevada nursing homes comes just days after health experts criticized the White House, which is currently in the midst of a coronavirus outbreak, for a misdirected reliance on rapid testing. For months, officials used two Abbott Laboratories products, ID NOW and BinaxNOW, to test people with no symptoms – another off-label use – while avoiding masks and physical distancing. In September, the White House also began distributing millions of BinaxNOW tests to communities across the country, including nursing homes across the country.