Thunder Bruce didn’t expect a photo of his friend’s grandfather being diagnosed with the flu to go viral. But when he shared the image on Twitter in December, he was inundated with messages.
People in the United States wanted to know how to buy rapid photo tests for three common respiratory infections: Covid, respiratory syncytial virus (RSV), and two types of influenza, types A and B. We screened for viruses at the same time.
The virus spread widely this winter, share many of the same symptomsThat is, they are often indistinguishable without diagnostic testing. But unlike over-the-counter Covid tests, tests for respiratory syncytial virus and flu must be done in a clinic or ordered by prescription. We do not approve home testing that can be done.
However, Brus’ photo rapid test is available in the EU, proving that the manufacturer meets EU health and safety standards.
Brus is the founder of Measie, a diagnostic vendor that sells tests online. Brus said the test cost him €6.50 ($6.92) and the company has sold about 10,000 so far.
Shenzhen Microprofit Biotech Co. Ltd., the manufacturer of the test, To tell Capture 100% of cases negative for Covid, flu, or RSV. That is, it does not generate false positives. It also detects 90% of influenza B cases, 92% of influenza A cases, 93% of Covid cases, and 95% of cases. % of RSV cases.
Brus said its performance should be sufficient to secure approval in the United States.
“A test conducted in my hometown of Amsterdam gives exactly the same results as a test conducted in New York. There should be no geographical differences,” he said.
Sheng Tang, deputy general manager of Shenzhen Microprofit Biotech, said the company has no plans to apply for emergency approval for testing in the United States. Due to regulatory constraints.
Susan Butler-Wu, PhD, an associate professor of clinical pathology at the University of Southern California, said rapid testing for multiple viruses is “the way of the future”, allowing more people to receive appropriate treatment. said deaf. But the United States has historically lagged behind Europe in approving new diagnostics, she said.
“It’s not uncommon to see great products approved in other countries, but not here. That’s the reality of the situation,” she said, adding, “It takes time to go through the process and get approval.” .”
FDA 1 approved no-prescription test This allows people to be swab tested for flu, Covid, and RSV at the same time, but the swabs must be mailed to LabCorp.
The FDA said it strongly supports home testing for respiratory viruses, including combined influenza and Covid testing. However, the agency declined to comment on whether it had received or evaluated applications for these tests from manufacturers.
An FDA spokeswoman said, “If the data are sound, the FDA will not hesitate to act quickly to approve testing, and home testing in all areas is a top priority for the agency.”
However, FDA points to one obstacle. Traditionally, home flu tests have required swabbing the high part of the nose. This usually means that the clinician should perform the test.
Butler-Wu says there are fewer opportunities to study whether a rapid flu test can be performed in the shallow nasal region to maintain accuracy, unlike Covid testing.
“We don’t want people to actually benefit from testing just by touching the outside of their nose,” said Joshua Scharfstein, a former FDA deputy commissioner and now a professor of health policy and management at Johns Hopkins University. Stated.
Dr. Michael Mina, chief scientific officer of home testing company eMed, said the FDA tends to impose stricter requirements on over-the-counter testing. Agencies often ask manufacturers to conduct studies demonstrating that people can successfully perform the tests at home, a process that costs millions of dollars, according to Mina. Test approval can be delayed by months or years.
“In the past, it took a very long time for new self-tests to be approved, such as HIV tests and pregnancy tests. It took years and years. I am taking it.”
In real life, Mina isn’t worried that the respiratory virus combo test is easy to use.
“Americans know they can swab their noses millions and millions of times because of Covid.
However, even if a doctor does a quick test, the FDA may have reservations about its accuracy. According to Butler-Wu, medical professionals’ rapid flu tests generally have a sensitivity of about 60%, with about a 40% chance of false negatives. For RSV, she said its performance is “slightly better,” but it’s still unreliable.
“There are long-standing problems with the performance of influenza and RSV antigen tests that are very well documented,” said Butler Wu. coin toss. We’re talking 50%.”
But as long as the tests are accurate and easy to use, the FDA’s data requirements are “not too onerous,” Sharfstein said. He added that authorities are usually able to make a decision on testing within months of an application being submitted.
“A test with high sensitivity and specificity doesn’t have a hard time getting FDA approval, but it’s important to understand how it was determined, what the procedure was, and actually look at the data. is important to the FDA,” Sharfstein said.
Mina hopes the FDA will approve a combined Covid-flu home test this month or next, though it may not look like the European version. Each may contain two separate swabs, which are packaged together, he said.
“The FDA is a little nervous about getting a fully combined test into people’s homes so soon.” not.”
But public health experts remain hopeful that a combined rapid test for Covid, flu and RSV will one day reach consumers.
The FDA “feels a lot of pressure from Americans,” Mina said. “With Americans and Europeans having access to these tests, as with Covid, there is pressure to say, ‘Why aren’t these? We’re starting to do that, and we’re actually somewhat amenable to working with manufacturers and seeing them pull it off.”
