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Los Angeles County health officials said on Sunday they would stop providing a commonly used coronavirus test after federal regulators raised questions about its accuracy.
The decision affects only a small number of county-supported mobile test sites. County health officials had already ended the widespread use of oral swab tests produced by the Silicon Valley start-up Curative over the summer over concerns over too many false negatives.
The use of curative oral swab tests at the city of Los Angeles’ 10 drive-thru testing sites, including the massive Dodger Stadium facility, is unaffected by Sunday’s decision. Mayor Eric Garcetti has defended the tests as being globally effective and said moving away from it could lead to a decrease in the number of people diagnosed and further spread of the virus.
A guide published last week by the Food and Drug Administration warned healthcare providers and patients that testing by Curative carries a “risk of false results, especially false negatives.”
To reduce the risk of false negatives, the curative test should only be used on “symptomatic individuals within 14 days of onset of symptoms of COVID-19”, and the swab should be observed and supervised by a professional. health, the FDA said.
Los Angeles has been using the tests since April. Responding to FDA recommendations last week, Garcetti has strongly supported the testing. While the curative test is designed to screen people who are visibly sick, he added that the tests are also effective at detecting cases in asymptomatic people. He said about a third of the city’s positive test results – about 92,000 – came from people without symptoms.
In June, LA County stopped using Curative’s oral swab testing at its major testing sites. Public health director Barbara Ferrer said at the time that nasal tests produced fewer false negatives.
In mid-December, however, Curative began providing testing at county-backed mobile testing sites. Between Dec. 13 and Jan. 2, Curative administered 24,241 tests at these county-backed sites, or about 10% of all coronavirus tests administered at those sites during that time, the Department of Health and Human Rights said on Sunday. County Social Services in a statement.
County officials said they were stopping using the curative tests “as a precaution” and would replace them with tests from Fulgent Genetics.
Health officials have said that any type of test carries a risk of false negatives, as the results rely on the correct collection of the saliva sample and the viral load it may contain.
“There is no reliable way to detect infection early, which means the infection often spreads before symptoms develop,” the statement said.
Nonetheless, county officials said curative tests are still better at detecting the disease than other tests, including rapid tests.
Curative, founded by a 25-year-old British businessman a year ago, has administered more than 11 million tests across the country, including in other major cities such as Chicago, San Francisco, Houston, Atlanta , Miami and Seattle. The company has a $ 42 million contract to perform tests at U.S. military treatment facilities and is also testing members of Congress, including those who do not have symptoms.
Unlike nasal swab tests, which must be administered by a healthcare professional deep into a patient’s nose, the curative test is an oral swab that can be self-administered. Patients should cough three times, rub the spit in their mouth, and then rub a cotton swab around their gums, cheeks, and tongue.
After the FDA guidelines released last week, a representative from Curative said in a statement that the company’s test “has been validated and is being offered during the pandemic under emergency use authorization, and is labeled with specific warnings, precautions and limitations that the FDA has reiterated. in safety communication. However, the test performance and labeling did not change and the company did not observe any change in the test performance. “
The Curative study conducted to validate its test ruled out asymptomatic patients, and the company told the FDA in its emergency clearance request that the test is “limited to patients with symptoms of COVID-19.” .
When the FDA issued an emergency use authorization for the Curative test in April, it specifically authorized testing of samples “from individuals suspected of COVID-19 by their health care provider.”
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