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L.A. County will stop using Curative coronavirus test after concerns from the FDA

Health officials in Los Angeles County said they would stop offering commonly used coronavirus tests on Sunday after federal regulators questioned their accuracy.

This decision only affects the few mobile test sites that the county supports. County health officials had already discontinued widespread use of oral swab tests created by Silicon Valley startup Curative in the summer due to concerns about too many false negatives.

The use of curative oral swab tests at 10 drive-through test sites in the City of Los Angeles, including a large facility at Dodger Stadium, is unaffected by Sunday’s decision. Mayor Eric Garcetti defended the test as widespread and effective, saying that leaving the test could reduce the number of people diagnosed and increase the spread of the virus.

Guidance issued last week by the Food and Drug Administration warned healthcare providers and patients that tests performed by curatives “at risk of false results, especially false negative results.”

To reduce the risk of false negatives, cure tests should only be used for “individuals with symptoms within 14 days of the onset of COVID-19 symptoms” and swabs should be observed and directed by healthcare professionals. The FDA said.

Los Angeles has been using the test since April. In response to last week’s FDA guidance, Garcetti strongly supported the test. Although the curative test is designed to screen people with visible illness, he added that the test is also effective in capturing cases of asymptomatic people. About one-third (about 92,000) of the positive test results from the city’s program come from asymptomatic people, he said.

In June, LA County discontinued the use of Curative’s oral swab test at major test sites. At the time, public health director Barbara Ferrer said there were fewer false negatives on nasal tests.

However, in mid-December, Curative began offering tests on county-supported mobile test sites. The County Department of Health and Human Services said in a statement on Sunday that between December 13th and January 2nd, Curative conducted 24,241 tests on sites supported by these counties, during which time such sites He said he had performed about 10% of all coronavirus tests conducted in.

County officials said they would discontinue use of cure trials “as a precautionary measure” and replace them with trials by Fulgent Genetics.

Health officials said that any type of test carries the risk of false negatives, as the results depend on the correct collection of saliva samples and the amount of virus they may contain.

“There is no reliable way to detect an early infection, which means that the infection often spreads before symptoms appear,” the statement said.

Nonetheless, county officials said curative tests were better at detecting illness than other tests, including rapid tests.

Founded a year ago by a 25-year-old British businessman, Curative has conducted more than 11 million tests nationwide, including in other major cities such as Chicago, San Francisco, Houston, Atlanta, Miami and Seattle. I will. The company has a $ 42 million contract to carry out tests at US military treatment facilities, and it also tests parliamentarians, including asymptomatic lawmakers.

Unlike the nasal swab test, which requires a medical professional to perform deep into the patient’s nose, the cure test is a self-administered oral swab. The patient should cough three times, spit in the mouth, and rub a cotton swab around the gums, cheeks, and tongue.

Following the FDA guidance issued last week, the treatment personnel said in a statement that the company’s tests were “verified and provided during a pandemic under an emergency use authorization, and certain warnings and cautions repeatedly stated by the FDA. Matters, and restrictions are labeled. ” With secure communication. However, the test performance and labeling have not changed, and the company has not observed any changes in test performance. “

A study conducted by Curative to validate the test excluded asymptomatic patients, and the company told the FDA that the test was “limited to patients with COVID-19 symptoms” in an emergency use authorization application. I told you.

When the FDA issued an emergency use authorization for curative testing in April, the FDA explicitly approved testing of samples “from individuals suspected of having COVID-19 by a healthcare provider.”



L.A. County will stop using Curative coronavirus test after concerns from the FDA Source link L.A. County will stop using Curative coronavirus test after concerns from the FDA

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