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FDA warns Curative’s COVID-19 test may produce false negatives



Covid-19 test kiosk
On January 8, 2021, the self-service kiosk in Berkeley. Photo: Pete Rosos

Mayor Jesse Arreguín advised Berkeley residents not to be tested for COVID-19 at the Curative test site on San Pablo Avenue because the FDA has raised questions about the accuracy of its results. But health officials in Alameda County are not so vigilant.

On January 4, the U.S. Food and Drug Administration (FDA) announced that Curative̵

7;s test results may produce false negative results.

“The U.S. Food and Drug Administration (FDA) is using the Curative SARS-Cov-2 test to warn patients and healthcare providers of false results, especially the risk of false negative results,” the warning read. “The risks of producing false negative results for patients include: delay or lack of supportive treatment, lack of symptom monitoring of infected individuals and their families or other close contacts, resulting in an increased risk of spreading COVID-19 in the community, or other accidents Adverse events.”

The warning prompted Berkeley officials to suggest that, at least so far, those seeking testing will look for operators other than Curative.

“Obviously, this new information is worrying and we are investigating it. We encourage residents to use other methods for testing, such as testing at the state-run Optum site operated by LHI or through its healthcare provider,” Arreguín wrote. Berkeleyside email. (See information on some new testing options at the bottom of the story).

Matthai Chakko, a spokesperson for the city of Berkeley, said Berkeley has contacted Curative and the state for more information.

Curative is a healthcare startup that was founded in January 2020 to develop sepsis tests and switched to COVID-19 testing in early March, promising that it will test millions of Americans. The company offers a physically less comfortable test method that relies on oral swabs instead of deep nasal swabs. The company opened a free pop-up test site in Berkeley in July last year and another test site in Oakland in December. Curative still operates test sites in Oakland, Berkeley, San Francisco, San Mateo, Palo Alto, and Los Angeles. According to Politico, it has already tested members of the U.S. Senate and House of Representatives.

Curative’s test was never approved by the FDA, but the agency did Authorization Use it urgently in April during the pandemic. But the FDA also pointed out in the warning that it only authorizes “curable” tests for people who show symptoms of the coronavirus (not people who are asymptomatic).​​​

According to the FDA warning, “the collection of nasal swabs and oral fluid samples is limited to symptomatic patients within 14 days after the onset of COVID-19 symptoms.”

Currently, treatment sites do provide tests for people who have no symptoms.

Academic research is divided on whether the oral fluid test provided by Curuid is as accurate as the nasopharyngeal or NP test, which uses a sample from the human nostril.

Since the beginning of the pandemic, the FDA has not issued a similar announcement regarding false negative tests. Archive. The Centers for Disease Control and Prevention (CDC) cancelled its preference for specific tests last spring, but also admitted the false negative problem. On the patient Fact Sheet, The Centers for Disease Control and Prevention warned: “For some COVID-19 patients, the test may give incorrect negative results (false negatives).”

Curative responded to the FDA’s statement stating that they are working with the agency to resolve its concerns.

The company’s CEO, Fred Turner, defended Curative’s test methodology: “Regarding the FDA safety communication, pointing out the risk of incorrect results in the Curative SARS-CoV-2 test, we are confident in our data. And we are working closely with the FDA. Testing sensitivity and accuracy on behalf of our patients is the core of our work.” He said.

The company also released a testimonial from the mayor of Los Angeles, Eric Garcetti, who said: “He still deeply trusts the Curative test,” the company said.

It is not clear how many COVID-19 tests Curative has conducted in Oakland and Berkeley.

The Alameda County Department of Public Health wrote in a statement to the City of Oakland today: “We are aware that the FDA has announced an announcement regarding therapeutic COVID-19 testing.” “Although the FDA announcement is worrying, we do not have any The information shows that these curative problems pose a greater threat to the public health of Alameda County. For these reasons, we abide by the FDA and its public statement.”

In June, Curative CEO Turner told Bloomberg that his company conducted approximately 25% of all tests in California. The company’s average turnaround time is maintained at 36 hours. Curative operates three laboratories: one located in Southern California, one located in Austin, Texas, and one established by KorvaLabs, which was acquired by CORVA in May 2020, and located in Washington, DC, FDA COVID-19 certified Testing laboratory. The company’s goal is to scale up to one million tests per week. Currently, Curative processes 25,000 tests per week, which is 2% of its target.

Curative operated a pop-up test kiosk in Berkeley in July. Since then, it has become the permanent site of Berkeley Adult School on San Pablo Avenue.Photo: Sarah Bellin

Test kit for care agent Instructions Individuals have to cough several times first, and then wipe inside the mouth. Last April, the study Research conducted by Curative, KorvaLabs, and UCLA showed that Curative’s test used oral swabs to detect more cases of COVID-19 infection, but there were 3 cases found using nasal swabs that were not in oral swabs. Found in.Researchers in conclusion Testing only the nose or mouth may “miss some cases of Covid-19 infection,” but the nose swab samples did show a greater amount of virus than the mouth swab samples.

This research is supported by another study that suggests that nasal swabs may detect the virus more accurately. The therapeutic research cited by the Alameda County Department of Public Health in its testing guidelines also has a relatively small sample size, including 45 symptomatic elderly people, patients with chronic diseases, emergency personnel, and law enforcement personnel, so they may not be promoted. To the general public.

Curative was founded by 25-year-old, Oxford-educated biotechnology entrepreneur Fred Turner (Fred Turner) to solve the shortage of COVID-19 testing, which hinders the federal and state’s efforts Epidemic response. An article on LinkedIn pointed out that Curative received $6 million from investors, including TED’s curator, Tinder’s former co-founder Justin Mateen’s Chris Anderson.

Curative hopes to differentiate itself from other test providers by providing “painless” testing methods. A Curative position announcement stated that Curative will “conduct 5-10% of all COVID-19 tests through a network of more than 10,000 test sites” within a year, and “we will develop our own software, develop our own tests and run our Own test site.” The site also claims that it has 100% test specificity. This means that Curative believes that 100% of their tests return “negative” to people who are truly uninfected.

By mid-October last year, Curative announced that it had tested 5 million people. On December 18, Lee Spraggon, CTO of Curative, said on Twitter that Curative had reached 10 million.

Curative California general manager Agatha Bacelar released a table in mid-November showing that Curative handled more tests than any other laboratory company. According to this table, Beceral said it was from the State Department of Public Health. 84% of the people who passed the Curative test got the results within 24 hours, and 100% got the results within 48 hours.

This is not the first time that certain tests and test providers have been flagged as false negative results. According to a document issued by the Alameda County government, in June last year, the health care company Abbott’s ID Now (a rapid test that produces results within 15 minutes) reported to the FDA. Compared with other tests, the number of false negative reports Increased. Public health. The FDA did not issue an advisory regarding the Abbott test.

The FDA reiterated in its press release that negative test results should not be the only measure of safe public health practice. In essence, the negative test does not give you a basis to allow others to violate social evacuation guidelines and shelter-in-place orders. As the Centers for Disease Control and Prevention (CDC) and medical experts have been warning for months, safe and healthy practices mean wearing a mask when going out in public places and maintaining a physical distance of at least six feet between yourself and others , And avoid as much as possible, especially indoor gatherings.

Some other testing options

Berkeley officials reiterated on Friday that people should not rely solely on COVID-19 testing to stop them from contracting the virus.

The city said in a statement: “Testing is an important part of our response, helping to identify cases of the virus that can easily spread.” “As the symptoms of COVID-19 are recognized, testing can help determine when to isolate. We also know that protective measures must be taken, such as staying at home, wearing a mask, avoiding crowds, and staying six feet away from people who are not at home. This is essential, because the virus may be available within two weeks. Undetectable. People may be tested prematurely after exposure and become positive later, unknowingly spreading it to others.




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