Mayor Jesse Arreguín is recommending that Berkeley residents avoid testing for COVID-19 at the Curative test site on Avenida San Pablo, now that the FDA is raising questions about the accuracy of its results. But Alameda County health officials are less cautious.
On January 4, the Food and Drug Administration announced that Curative tests may be producing false-negative results.
“The US Food and Drug Administration (FDA) is warning patients and healthcare professionals about the risk of false results, particularly false negative results, with the SARS-Cov-2 curative test,” the alert said. “The risks to a patient of a false negative result include: delay or lack of supportive treatment, lack of monitoring of infected individuals and their family or other close contacts for symptoms, resulting in an increased risk of spreading COVID-19 in the community, or other unintended adverse events. “
The warning is prompting Berkeley officials to suggest that those who want to take the test look for operators other than Curative, at least for now.
“Obviously, this new information is a concern and we’re investigating it, and we encourage residents to access other ways to get tested, like on the Optum website administered by LHI or through their health care providers,” wrote Arreguín in an e- mail to Berkeleyside. (See information at the end of the story for some new test options).
Berkeley contacted Curative and the state for more information, said Matthai Chakko, the city’s spokesman.
Curative, a health startup founded in January 2020 to develop tests for sepsis, turned in early March to run COVID-19 tests and made promises that it would test millions of Americans. The company – which offers a less physically uncomfortable test method using a mouth swab instead of a deep nasal cavity swab – opened a free pop-up test site in Berkeley last July 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 and, according to the Politico, tested members of the US Senate and House of Representatives.
The curative test was never approved by the FDA, but the agency did authorize for emergency use in April during the pandemic. But the FDA also pointed out in its warning that it had authorized curative testing only for people who had symptoms of the coronavirus, not for those who were asymptomatic.
“The collection of nasal swabs and oral fluid samples is limited to symptomatic individuals within 14 days of the onset of COVID-19 symptoms,” according to the FDA warning.
Curative sites currently offer tests for people without symptoms.
Academic studies differ on whether oral fluid tests, such as those offered by Curative, are as accurate as nasopharynx or PN tests, one that uses a sample from inside a person’s nostrils.
The FDA has not made a similar announcement about false negative tests since the pandemic began, according to its archive. The Centers for Disease Control and Prevention (CDC) withdrew their preference for a specific test last spring, but also recognized the problem of false negatives. In one patient Datasheet, the CDC warns that “it is possible that this test will give a negative result that is incorrect (false negative) in some people with COVID-19.”
Curative responded to the FDA’s announcement with a statement that it is working with the agency to address its concerns.
The company’s CEO, Fred Turner, defended the Curative test method: “Regarding FDA safety reporting looking at the risk of false results with the Curative SARS-CoV-2 test, we are confident in our data and are working with the FDA closely does not matter. Testing sensitivity and accuracy on behalf of our patients is at the heart of our work, ”he said.
The company also released a statement from Los Angeles Mayor Eric Garcetti, who said “he still trusts Curative tests ‘deeply’,” according to the company.
It is not immediately clear how many COVID-19 tests were carried out by Curative in Oakland and Berkeley.
“We are aware of the FDA announcement about the COVID-19 curative test,” wrote the Alameda County Department of Public Health in a statement to The Oaklandside today. “While the FDA announcement is worrying, we have no information to suggest that these problems with Curative pose a broader threat to public health in Alameda County. For these reasons, we are referring to the FDA and its public announcement. “
In June, Curative CEO Turner told Bloomberg that his company was conducting about 25% of all tests in California. The company maintained an average delivery time of 36 hours. Curative operates three laboratories: one in Southern California, a laboratory in Austin, Texas, and an FDA COVID-19 certified test laboratory in Washington DC, established by KorvaLabs, a Curative company acquired in May 2020. The purpose of the company is increasing up to one million tests a week. Curative currently processes 25,000 exams a week, 2% of its target.
Dressing test kit instruct individuals cough deeply several times and then rub the inside of the mouth. Last April, a study by Curative, KorvaLabs and UCLA showed that the Curative test detected more cases of COVID-19 infection using the mouth swab method, but there were also three cases found using the nasal swab method that were not found in the mouth swab samples. The researchers concluded that testing just the nose or mouth can “miss some cases of Covid-19 infection,” but the nose swab samples showed greater amounts of the virus than the mouth swab samples.
This finding was supported by another study that suggests that nasal swabs may be more accurate in detecting the virus. The curative study, which the Alameda County Department of Public Health cites in its testing guidelines, also had a relatively small sample of 45 symptomatic elderly people, people with chronic illnesses, first responders and police, so it may not be generalizable to the public at large. general.
Curative was founded by Fred Turner, a 25-year-old Oxford-based biotechnology entrepreneur to address the scarcity of COVID-19 tests that has hampered federal and state responses to the pandemic. A LinkedIn article states that Curative received six million dollars from investors, including Chris Anderson, TED curator and former Tinder co-founder, Justin Mateen.
Curative hoped to differentiate itself from other test providers by offering a “painless” test method. A job announcement from Curative states that within a year, Curative will conduct “5-10% of all COVID-19 tests through a network of more than 10,000 test sites” and that “we build our own software, we develop our own tests and run our own test sites. ”The website also claims to have a 100% test specificity. This means that Curative believes that 100% of its tests return “negative” for individuals who are not really infected.
In mid-October last year, Curative announced had tested five million people. On December 18, Curative’s chief technology officer, Lee Spraggon, tweeted that dressing had reached 10 million.
Agatha Bacelar, Curative general manager for California, tweeted in mid-November, a table showing that Curative was processing more tests than any other laboratory company. According to the table, which Bacelar said was from the state’s Department of Public Health, 84 percent of the people tested by Curative had their results within 24 hours, and that 100 percent had their results returned within 48 hours.
This is not the first time that certain tests and test providers have been flagged for false negative results. Last June, health care company Abbott’s ID Now, a rapid test that produces results in 15 minutes, was reported to the FDA for an increasing number of false-negative reports compared to other tests, according to a document published by the Department of Health. Alameda County Public Health. The FDA has not issued a warning about the Abbott test.
The FDA reiterated in its press release that negative test results should not be the only measure of safe public health practices. Essentially, the negative test does not give permission for people to violate social detachment guidelines and shelter orders on the spot. As the CDC and medical experts have been warning for months, safe and healthy practices mean wearing a face mask when in public, putting at least six feet between you and others and avoiding large meetings, especially in indoors as much as possible.
A few more options to take the test
Berkeley officials reiterated on Friday that people should not rely solely on COVID-19 tests to prevent them from contracting the virus.
“Tests are an essential part of our response, helping to identify cases of viruses that spread easily,” the city said in a statement. “Along with recognizing the symptoms of COVID-19, the tests help to identify when to isolate and quarantine. We also know that protective actions – such as staying at home, wearing face covers, avoiding crowds and staying within a meter of those who are not at home – are essential because the virus may not be detected by any test by two weeks. People can get tested very early after exposure and become positive later, without knowing it, by spreading it to others.