Why Doesn’t the US Have At-Home Tests for the Flu?

When a fever and sore throat or cough strike, the symptoms point to many possible illnesses. Common culprits are influenza, respiratory syncytial virus (RSV), or COVID-19. Americans are now accustomed to buying at-home COVID test kits, swabbing, waiting, and interpreting the results themselves. But what about at-home tests for the flu? 

In Europe, it’s now possible to buy an at-home test that looks for not only COVID, but also flu and RSV, for about $7. The company that makes the test, Shenzhen Microprofit Biotech Co. Ltd., does not plan to seek authorization from the FDA in the short term, NBC News reported.

In Australia, combined at-home self tests for flu and COVID have been available since September last year. 

For anyone in the U.S. who doesn’t want to make the trip to a medical clinic to get tested for flu or RSV, an at-home option does exist. But it can cost up to $169 and take a couple of days to get results after arranging FedEx pickup or going to a drop-off location. The Pixel test is available from Labcorp and tests for COVID, flu, and RSV. Insurance may cover the entire test cost in some situations, and results are available online, according to Labcorp.

Rapid tests for flu and RSV aren’t available in the U.S. because of the strict criteria the FDA requires and because there is concern that people would not swab deep enough into the nose for the tests to be accurate, experts told NBC News.

“It’s not unusual to see things that have been approved in other countries that are great products and we don’t have them here. That’s just the reality of the situation,” Susan Butler-Wu, PhD, associate professor of clinical pathology at the University of Southern California, told NBC News. “It takes time to go through the process and get approval.”

FDA officials declined to comment on whether any applications are being processed for combined tests. 

Sources

Shenzhen Microprofit Biotech Co. Ltd.: “Information of MF-71 SARS-CoV-2 & Influenza A/B & RSV Antigen Combo Test Kit.”

NBC News: “Rapid tests for Covid, RSV and the flu are available in Europe. Why not in the U.S.?”

Australian Department of Health and Aged Care: “First combination COVID-19 and influenza self-tests approved for Australia.”

PreViral.com: “Combo Antigen Rapid Test Kit – Fluorecare (SARS-CoV-2 & Influenza) €162,50. This box contains 25 tests for only €6,50 per test.”

Labcorp OnDemand: “COVID-19 + Flu + RSV Test Home Collection Kit.”

Source: Read Full Article