Sander Brass didn’t expect a photo of his friend’s grandfather’s flu diagnosis to go viral. But when she shared the photo on Twitter in December, she was bombarded with messages, she said.
People in the United States wanted to know how to buy the rapid test in the picture. Which simultaneously screens people for three common respiratory viruses: Covid. Respiratory syncytial virus (RSV). And two types of influenza, A and B.
The viruses have been rampant this winter and share many of the same symptoms, meaning they are often indistinguishable. Without diagnostic testing. But unlike the Covid test, which is
available over the counter, RSV and flu tests must be done at a doctor’s office or ordered by prescription. And the FDA has not approved a home test that can quickly detect all three viruses at once.
A quick check from Bruce’s photo, however, is available in the European Union. Wnd the manufacturer has certified that it is E.U. Meets its health and safety standards.
Brus is the founder of Measie, a diagnostic vendor that sells tests online. The test costs 6.5 euros ($6.92), and the company has sold about 10,000 of them so far, Brass said.
Test manufacturer, Shenzhen Microprofit Biotech Co. Ltd. says it captures 100% of cases that are negative for covid. Flu or RSV — meaning it won’t produce false positives — and picks up 90% of influenza b cases, 92% for influenza a, 93% for covid % and 95% for RSV
Brass said that performance should be enough for approval in the United States.
“A test done in Amsterdam, where I’m from, will give exactly the same results as a test done in New York. There should be no difference based on geography,” he said. “But still, people in the United States can’t use it, and I can.”
Sheng Tang, vice general manager of Shenzhen Microprofit Biotech. Said the company has no plans to apply for emergency approval for the test in the U.S. Tang said in an email that he doesn’t think the Food. nd Drug Administration will approve it. Given its regulatory constraints.
Dr. Susan Butler-Wu. An associate professor of clinical pathology at the University of Southern California. Said rapid testing for multiple viruses is “the way of the future. nd will help more people get access to appropriate treatment. But the United States has historically lagged behind Europe in approving new diagnostics, he said.
“It’s not unusual to see things approved in other countries that are great products and we don’t have them here. That’s the reality of the situation,” he said.
The FDA has approved a non-prescription test that allows people to swab themselves for flu, CovidThe test costs $169 for people without insurance.
The FDA said it strongly supports at-home testing for respiratory viruses, including a combination test for flu and Covid. However, the agency declined to comment on whether it has received or is evaluating any applications. For these tests from manufacturers.
“When the data is accurate, FDA has not hesitated to move quickly to approve tests. Making at-home tests a high priority for the agency in all areas,” an FDA spokesman said.
The agency pointed to one roadblock, though: At-home flu tests traditionally require people to hold their nose up. Which usually means a physician must administer them.
Unlike the Covid test, Butler-Wu said, there has been less opportunity to study. Whether rapid flu tests can be performed in the shallow part of the nose and maintain their accuracy.
“You don’t want people just touching the outside of their nose and not really getting the benefit of the test,” said Joshua Sharfstein. A former FDA deputy commissioner now a professor of health policy and management at Johns Hopkins University.
Dr. Michael Mina, chief science officer for home testing company eMed. Said the FDA has strict requirements for over-the-counter testing. The agency often asks manufacturers. To conduct studies that show people can properly administer the test at.Home — a process that can cost millions of dollars. And delay approval of the test by months or years, Mina said.
It took a lot longer in the past for new self-tests like HIV tests or even pregnancy tests to get approved,”
he said. “They took years and years. We have a pretty conservative regulatory approach.”
In real life, Mina isn’t worried about the combo test for respiratory viruses being user-friendly.
Even if a doctor administers a rapid test, however, the FDA may still have reservations about its accuracy.