Health officials in Los Angeles County said Sunday they will stop delivering a commonly used coronavirus test after federal regulators asked questions about its accuracy.
The decision affects only a small number of mobile testing sites supported by the province. Official health officials have already ended the widespread use of oral water tests that discontinued the Silicon Valley essay Curative over the summer due to concerns about too many false negatives.
Sunday’s decision does not affect the use of Curative oral swab tests on the ten drive-through test areas in Los Angeles, including the massive facility at Dodger Stadium. Mayor Eric Garcetti generally defended the tests effectively, saying that moving away from them could lead to fewer people being diagnosed and that the virus spreads more widely.
Information released by the Food and Drug Administration last week warned health care providers and patients that the Curative test poses a “risk of false results, especially false negative results.”
To reduce the risk of false negatives, the Curative test should only be used on ‘symptomatic individuals within 14 days of the onset of the COVID-19 symptom’, and the swab should be observed and directed by a healthcare professional. the FDA said.
Los Angeles has been using the tests since April. In response to FDA guidance last week, Garcetti strongly supported the test. While the Curative test is designed to examine people who are visibly ill, he added that the tests are also effective in detecting cases in people who are asymptomatic. He said about one-third of the positive test results of the city’s program – about 92,000 – were from people without symptoms.
In June, LA County discontinued the use of Curative’s mouth test on its main test areas. The director of public health, Barbara Ferrer, said at the time that nose tests yielded fewer false negatives.
In mid-December, however, Curative began testing on mobile testing sites supported by the country. Between December 13 and January 2, Curative supported 24,241 tests in these provinces, about 10% of all coronavirus tests administered at such sites during such time, the Department of Health and Human Services said in a statement Sunday.
Provincial officials have said they will stop using the curative tests “as a precaution” and will replace them with tests by Fulgent Genetics.
Health officials said that any type of test carries a risk of false negatives, because the results depend on the correct collection of the saliva sample and the virus load it may contain.
“There is no reliable way to detect early infection, which means that infection often spreads before symptoms develop,” the statement said.
Nevertheless, provincial officials said the curative tests are still better at detecting diseases than other tests, including rapid tests.
Curative, founded a year ago by a 25-year-old British businessman, has taken more than 11 million tests nationwide, including in other major cities such as Chicago, San Francisco, Houston, Atlanta, Miami and Seattle. The company has a $ 42 million contract to conduct tests in U.S. military treatment facilities and also tests members of Congress, including those who have no symptoms.
Unlike nasal swab tests, which must be administered by a medical professional deep into a patient’s nose, the curative test is an oral swab that can be self-administered. Patients are expected to cough three times, rub the saliva in their mouth and then a cotton swab to rub their gums, cheeks and tongue.
After the FDA guidelines were issued last week, a Curative representative said in a statement that the company’s test had been ‘validated and presented during the pandemic under an emergency authorization, and it was marked with specific warnings , precautions and restrictions that the FDA has repeated. in the Safety Communication. However, the test performance and labeling did not change, and the company also did not observe any changes in the test performance. ”
The Curative study conducted to validate the test excludes patients who were asymptomatic, and the company said in its application for emergency approval to the FDA that the test was ‘limited to patients with symptoms of COVID-19’.
When the FDA issued an emergency use authorization for the Curative test in April, it approved the test specifically for samples ‘of individuals suspected by their healthcare provider of COVID-19’.