Reliability of Covid-19 Tests Is Questioned; Curative Test May be Providing False Negatives

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Cars were lined up at Dodger Stadium with people who waited to be tested for Covid.

In November, Circling the News sent several queries to the L.A. County Department of Public Health about the reliability of the Covid tests being given. Elon Musk had tweeted that he had taken four tests, two of which were negative, two were positive.

My daughter had taken two tests: the first (at the VA) was inconclusive, and the second (at an Urgent Care in Culver City) was negative.

When I asked a local doctor about the accuracy of the tests, he sent a link to a website that showed that rapid tests were between 30 and 80 percent accurate. Women who have taken a pregnancy test would eschew a test with that kind of result.

The County Health Department never returned my queries.

According to a January 4 story in Modern Healthcare (“FDA Issues Alert about False Negative Results with Curative Covid-19 Test”), the Food and Drug Administration warned of false negative results with the SARS-CoV-2 laboratory-based test from San Dimas-based Curative.

This test is being used in Los Angeles and other major metropolitan areas, and the company was awarded a contract in November to test federal lawmakers, according to NBC News.

The story noted that FDA warned that results may not be accurate and urged healthcare providers to consider having patients get “re-tested” if they had recently received a test from Curative.

The PCR-based test is authorized for use with a throat swab, nasopharyngeal swab, nasal swab, or oral fluid specimens for the detection of nucleic acid from SARS-CoV-2.

The FDA statement highlighted that use of nasal swabs and oral fluid specimens is limited to symptomatic individuals within 14 days of Covid-19 symptom onset, and specimen collection must be directly observed and directed during the sample collection process by a trained healthcare worker at the specimen collection site.

According to Radio.com 94.7 The Wave (“FDA Issues Warning about Risk of False Negatives with Curative’s Covid-19Test – Widely Used in LA County”), “the City of L.A. offers the test to anyone, regardless of whether they have any symptoms. People swab themselves in their vehicle – without observation – and then toss the sample into a container.”

To reduce the risk of false negative, the FDA said swabs should be limited to patients who have Covid-19 symptoms and who test within 14 days of when their symptoms start, and the specimen collection “must be directly observed and directed…by a trained healthcare worker.”

A January 5 NBC story (“FDA Warns Congress about Covid Test that May Give False Results”) noted that those with Congressional ID have taken the test, which “has been popular and heavily relied upon, particularly on Congressional travel days and in recent weeks due to the holidays.”

“I am a bit alarmed that Fred Turner, the 25-year-old founder of Curative Inc., with no medical background was awarded the contract for testing lawmakers, staff and the media in the U.S. Capitol,” one Republican Senate aide said. “I have been reliant on this service and cautiously optimistic that it’s reliable.”

In an email to Modern Healthcare in the January 4 story, Curative CEO Turner said that the firm “disagrees with the assessment” made by FDA that the test has performance issues. The firm intends to publish the results of a large clinical trial soon, he said.

When asked by a radio reporter this afternoon (January 7), L.A. County Department of Health released the following statement that “DHS is aware of the alert from the FDA about the risk of false negative results with Curative COVID-10 PCR test and we are reviewing and assessing results from clinical studies. . . .Through the County’s result notification process, we remind residents of the risk of false negatives. . .”

 

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