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After FDA concerns, Los Angeles County will stop using therapeutic coronavirus tests



Los Angeles County health officials said on Sunday that they will stop providing common coronavirus tests after federal regulators question its accuracy.

The decision only affects mobile test sites supported by a few counties. Fearing too many false negatives, county health officials have stopped the widespread use of oral swab tests produced by Silicon Valley startup Curative during the summer.

The use of “therapeutic oral swabs” at 10 through-train test sites in the city of Los Angeles (including the large facilities at Dodger Stadium) is not affected by Sunday̵

7;s decision. Mayor Eric Garcetti defended the test, saying that the test is widely effective, and that staying away from these tests may result in fewer people being diagnosed and the spread of more viruses.

Guidelines issued by the Food and Drug Administration last week warned healthcare providers and patients that the tests conducted by Curative carry “the risk of false results, especially the risk of false negative results.”

The FDA said that in order to reduce the risk of false negatives, the cure test should only be used on “people who have symptoms within 14 days of the onset of COVID-19 symptoms”, and the swab should be observed and guided by medical staff.

Since April, Los Angeles has been using these tests. In response to the FDA’s guidance last week, Garcetti firmly supported the test. Although the “curative” tests are designed to screen people with obvious diseases, he added that these tests can also effectively find asymptomatic people. He said that about a third (about 92,000) of the positive test results planned by the city came from asymptomatic people.

In June, Los Angeles County stopped using Curative’s oral swab test at its main test site. Public Health Director Barbara Ferrer said at the time that nasal examinations produced fewer false negatives.

However, in mid-December, Curative began offering tests on mobile test sites supported by the county. The County Department of Health and Human Services said in a statement that between December 13 and January 2, Curative conducted 24,241 tests at these county-supported locations, accounting for approximately all the coronaviruses performed at these locations during that period. 10% of the virus test.

County officials said that “as a preventive measure” they will stop using therapeutic tests and will replace them with Fulgent Genetics tests.

Health officials said there is a risk of false negatives in any type of test because the test results depend on the correct collection of saliva samples and the viral load that they may contain.

The statement said: “There is no reliable way to detect early infections, which means that infections usually spread before symptoms develop.”

Despite this, county officials say that therapeutic tests still perform better in detecting diseases compared to other tests, including rapid tests.

Curative was founded by a 25-year-old British businessman a year ago and conducted more than 11 million tests nationwide a year ago, including in other major cities such as Chicago, San Francisco, Houston, Atlanta, Miami and Seattle. The company holds a $42 million contract for testing in U.S. military treatment facilities and also tests on members of Congress (including those without symptoms).

Unlike the nasal swab test, which must be performed by a professional deep in the patient’s nose, the Curative test is a self-administered oral swab. Ask the patient to cough three times, spit out the mouth, and then wipe the cotton swabs around the gums, cheeks and tongue.

After the FDA issued the guidance last week, a representative of the person in charge said in a statement that the company’s test “has been verified and provided under an emergency use authorization during the pandemic, and is marked with a specific reiterated by the FDA. Warnings, precautions and restrictions. In the safety communication. But the test performance and labeling have not changed, and the company has not observed any changes in the test performance.”

The study conducted by Curative aims to verify whether its test excludes asymptomatic patients. The company told the FDA when applying for emergency authorization that the test is “limited to patients with COVID-19 symptoms.”

When the FDA issued an emergency use authorization for the Curative test in April, it specifically authorized the test samples “from individuals suspected by their healthcare providers to be COVID-19.”

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