Trump Administration Orders Nevada to Allow Rapid Covid-19 Tests in Nursing Homes
October 09 2020 - 4:48PM
Dow Jones News
By Anna Wilde Mathews and Brianna Abbott
The Trump administration ordered the state of Nevada to withdraw
a directive blocking nursing homes from using federally provided
rapid coronavirus testing equipment, highlighting a debate over the
proper use of the tests after reports of some false-positive
results.
In a letter to Nevada officials, Adm. Brett Giroir, the
Department of Health and Human Services official who has overseen
U.S. testing efforts, said the state's action is "inconsistent with
and pre-empted by federal law and, as such, must cease immediately
or appropriate action will be taken against those involved." The
letter was dated Oct. 8 and made public Friday.
Adm. Giroir defended the performance of the federally supplied
equipment on a call Friday with reporters, saying the
false-positive rate was low and the issue could be managed by using
proper procedures to confirm results. The state's action wasn't
justified, he said. Adm. Giroir declined to say what enforcement
action the federal government could take against Nevada, but said
he expected the state to comply with the federal order.
The Nevada Department of Health and Human Services didn't
immediately respond to a request for comment. Nevada told nursing
homes on Oct. 2 to stop using the rapid-testing equipment, citing
concerns about false-positive results.
The federal government has been supplying equipment from Quidel
Corp. and Becton Dickinson & Co. to about 14,000 nursing homes
around the country, which can use the machines to fulfill a federal
mandate to test staffers. They perform point-of-care antigen tests
that don't have to be sent to labs for processing. Antigen tests
focus on virus proteins, while molecular tests look for the virus's
genetic material.
Any type of diagnostic or clinical test will produce some number
of false positives, laboratory scientists say. Rapid antigen tests
are cheap and can provide quick, repeatable results, but they also
tend to be less accurate than the laboratory-based molecular tests.
Antigen tests are more likely to produce false negatives, but they
can also produce false-positive results, especially as a part of
wider screening programs in communities where the prevalence of the
disease is low.
"It's just a matter of understanding that some false positives
are inevitable," Adm. Giroir said during the press call. "And you
need to deal with them the right, correct way."
False-positive test results are a particularly significant risk
in nursing homes, because a resident wrongly believed to have
Covid-19 could be placed in an area dedicated to infected patients,
potentially exposing an uninfected person to the coronavirus.
Nursing homes around the country have reported some
false-positive results from rapid antigen-testing equipment. A
survey that nursing-home industry groups did of their members found
that most reporting discordant results had only a few, which would
be expected, according to a summary of the findings. However, a
small share had a larger number, and those cases should be
investigated, the summary report said.
In its Oct. 2 order, Nevada said that nursing homes had reported
confirmatory testing on 39 positive coronavirus results obtained
from the antigen equipment. Twenty-three of them were found to be
negative in re-tests done with molecular assays. Overall, the state
said, 3,725 of the rapid antigen tests had been performed by the
nursing homes.
In statements, both Becton Dickinson and Quidel said they were
pleased by the federal action and had full confidence in their
equipment. Becton Dickinson said the Nevada findings showed its
system was performing as intended. Quidel said that further
investigation was needed before Nevada took action, and that the
company's "initial due diligence suggests that there may be issues
with sample collection and processing protocols" at nursing homes
reporting false positives.
Because of the potential for false-positive and false-negative
results, many public health authorities, including the U.S. Centers
for Disease Control and Prevention, advise that some patients get a
second, confirmatory test following a rapid-test result, depending
on the specific circumstances. For instance, nursing homes
shouldn't use antigen tests to determine whether a symptomless
person should be put in a ward with other Covid patients without a
follow-up molecular test, Adm. Giroir said.
"You should not make a clinical decision on an otherwise well
individual not in an outbreak just based on a single test," he
said.
Other state officials have also raised concerns that rapid
antigen tests pose a risk of less-precise results. On Oct. 5,
Massachusetts said the antigen tests couldn't be used to satisfy
state testing requirements for nursing homes. The state cited
"limited data to guide the use of rapid antigen tests as screening
tests on asymptomatic persons."
Write to Anna Wilde Mathews at anna.mathews@wsj.com and Brianna
Abbott at brianna.abbott@wsj.com
(END) Dow Jones Newswires
October 09, 2020 16:33 ET (20:33 GMT)
Copyright (c) 2020 Dow Jones & Company, Inc.
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