WASHINGTON — Nevada public health officials’ recent actions preventing nursing homes from using rapid screening tests for COVID-19 are “unjustified” and don’t follow the science on testing, Department of Health and Human Services (HHS) “testing czar” Adm. Brett Giroir, MD, said Friday.
The state’s actions are “not scientifically valid. They must cease their prohibition immediately,” Giroir said on a phone call with reporters. “If you need technical support,” he told the nursing homes, “we are enthusiastic to do more. Lives are at stake and our administration is not going to allow action to risk our seniors or any other vulnerable or underserved population.”
Letter Sent to Nursing Homes
On October 2, the Nevada Department of Health and Human Services sent a letter to healthcare providers and long-term care facilities, noting that the Centers for Medicare & Medicaid Services had sent point-of-care antigen tests to nursing homes across the country — specifically, the Quidel Sofia test and Becton Dickinson’s Veritor test. The letter noted that according to the FDA’s emergency use authorization data, Quidel claimed 87% sensitivity and 100% specificity for its test, while Becton Dickinson’s numbers were 97.5% and 100%, respectively.
“However, this was based on extremely limited data,” wrote Ihsan Azzam, MD, PhD, the state’s chief medical officer, and two colleagues. The state conducted its own test after it “started receiving anecdotal reports from SNFs [skilled nursing facilities] that individuals with a positive antigen test were subsequently testing negative” with polymerase chain reaction (PCR) assays, generally considered the most accurate. The state looked at data from 12 nursing homes that conducted 3,725 rapid tests, of which 60 came back positive. Of those, 39 were sent for PCR testing; 16 (40%) came back as true positives while 23 (60%) were false positives.
“Possible reasons for conflicting test results include lack of compliance with the manufacturer’s protocols; inadequate training on the testing procedure, or false negatives with the confirmation RT-PCR test especially if the confirmatory PCR test could not be performed within 48 hours of the positive antigen test,” the letter continued. “Additionally, low prevalence and incidence of COVID-19 within a community may result in higher rates of false positive tests.” The letter ordered the facilities to “immediately discontinue the use of all COVID-19 point of care antigen tests until the accuracy of the tests can be better evaluated.” Instead, it recommended that facilities use molecular testing such as PCR tests or Abbott’s ID NOW test.
‘A Fundamental Lack of Basic Knowledge’
Nevada officials’ letter “can only be interpreted as reflecting a fundamental lack of basic knowledge about testing and interpreting results,” Giroir told reporters. “Science is on the administration’s side, and the administration is on the side of science.” He called the 40% true positive rate an “outstanding result” and said that the additional testing required to make sure the positive results were accurate — and taking a nursing home worker out of the staff for 48 hours pending a confirmatory result — “is a minuscule price to pay for identifying and isolating those who are infected, infectious, and can devastate our elderly in nursing homes.” He wrote to the state on Thursday, asserting, “Your letter can only be based on a lack of knowledge or bias, and will endanger the lives of our most vulnerable.”
“Under federal law, Nevada may not prohibit or effectively prohibit such testing at congregate facilities,” Giroir wrote. “While we welcome the opportunity to discuss your concerns with those two tests, the Department of Health and Human Services will take appropriate steps if you do not cease the improper unilateral prohibition.”
During the press call, Giroir declined to say what those steps might be. “There are a number of important mechanisms we have at our discretion, and I’m not going to go into those here,” he said. “I’m really confident that once the issues on the table and the public health officials understand, that they’re going to comply with this … It’s a matter of understanding some false positives are inevitable and you need to deal with them in the correct way.”
Giroir told MedPage Today that the number of false positives compared to true positives “will always depend on the prevalence or the risk of the actual disease in the population you test. For example, in a low-incidence school district, you can get as many as 30 false positives for every true positive; if you’re even in a moderate, you could get 7 to 1.” So, 40% “is a very good result, because we’re not in a place where 50% of the people have COVID.”
Advances in Vaccine Trials, Therapeutics
Meanwhile, on another call with the press, HHS officials touted the progress being made with the Operation Warp Speed effort to ramp up development of COVID-19 vaccines and therapeutics. Paul Mango, HHS deputy chief of staff for policy, said that in terms of minority participants in vaccine clinical trials, “we believe we’ve exceeded the threshold necessary to ensure we have appropriate diversity in those trials.” Moderna and Pfizer, the two companies farthest along in their vaccine development, have “essentially completed” recruiting for their trials, while Johnson & Johnson’s Janssen unit has just started recruiting in the last few weeks, although unlike the other two companies, the latter’s vaccine is a single dose, “so we anticipate they’ll get through their clinical trials a bit faster than the other two,” he said.
As far as vaccine distribution goes, “we’re in the process of actively engaging tens of thousands of provider outlets for these vaccines, and we anticipate having collectively 65,000-to-75,000 points of potential vaccination,” Mango said. Jay Butler, MD, deputy director for infectious diseases at the CDC, reported that all of the jurisdictions his agency works with — 50 states, the District of Columbia, eight U.S. territories, and five large city health departments — are on track to meet the October 16 deadline for submitting their vaccine distribution plans. Mango estimated that the companies involved — which are all beginning to manufacture their vaccines in advance of approval or emergency use authorization — would have “a minimum of 100 million doses” manufactured in total before the end of the year.
That doesn’t mean all those doses will be given an emergency use authorization by the end of the year, “but we’ll certainly have enough to get to the 30 or 40 million Americans who are the most vulnerable,” he added.
Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, noted that two of the companies working on monoclonal antibody therapies, Eli Lilly and Regeneron, “announced that they found that giving antibody early in the course of disease helps in rapidly clearing the virus from the body … They found a shortening of the duration of symptoms, and Regeneron found the main effect was in people that by their assay were seronegative — they hadn’t started making their own antibodies to the virus,” while Lilly found its therapy “appeared numerically … to decrease the number of hospitalizations of patients who received the antibody compared to placebo.” Both firms have applied to the FDA for emergency use authorization for their products.