First At-Home Test for Flu and Covid Is OK’d by the FDA

The combination test correctly identified 99 percent of negative and 90 percent of positive flu A samples, according to the F.D.A. It also detected 100 percent of the negative and 88 percent of the positive Covid samples. The agency said it expected the company to continue to test on the flu B strain, which was not prevalent this year.

The product is a molecular test, which means it detects and amplifies the genetic material of the viruses, as a P.C.R. test does. These tests are generally more sensitive than antigen tests, and at-home molecular tests have been more expensive than rapid antigen tests.

The new test will be the first of a series of combination diagnostics in different stages of development that will scan for multiple ailments at once, said Dr. Wilbur Lam, a pediatric hematologist and bioengineer at Emory University who has helped federal officials with test development and validation.

“Now we’re in this new era that’s honestly pretty exciting,” Dr. Lam said. “It’s exciting for a health care provider, it’s exciting for the technology developers, and I think exciting for the public because we have this new test. And this is only the beginning.”

Through the pandemic, some public health experts have criticized the F.D.A. for being slow to approve at-home Covid tests and the federal government for failing to make the tests more widely available to Americans at little or no cost. Even once at-home tests were approved, fluctuating demand prompted manufacturers to ramp down production, contributing to shortages of rapid tests when the virus came surging back.

During the first years of the pandemic, flu activity was unusually low. But last fall, with most pandemic precautions gone, the flu re-emerged in alarming numbers so early in the flu season. Over the last several months, Americans have had to contend with waves of multiple viruses, including influenza, the coronavirus and respiratory syncytial virus, or R.S.V.

Article source: https://www.nytimes.com/2023/02/24/health/covid-flu-test-fda.html