For three years of the pandemic, people suffering from runny noses and fevers have been sweating the tough question: “Is this the COVID that killed over a million Americans, or is it the flu that’s more familiar?” Many symptoms overlap. But now, the first home test that distinguishes between COVID and influenza has been approved by the US Food and Drug Administration. With just one swab, the test can distinguish between three respiratory viruses (the COVID-causing pathogen SARS-CoV-2 and influenza A and B) with high accuracy in 30 minutes.
Unfortunately, the future of the product remains uncertain. The FDA’s Emergency Use Authorization for the test was issued in late February, just two days after the test’s manufacturer, Lucira Health, announced it had filed for Chapter 11 bankruptcy protection.
Flu and COVID tests were already approved for home use in Canada and Europe, and for use in U.S. health care facilities, such as hospitals and clinics, prior to FDA emergency use authorization. is allowed to be sold directly to consumers without a prescription, and the technology is more like a sophisticated lab-based polymerase chain reaction (PCR) test than the frequently used home antigen test. Similar to , Lucira’s products use enzymes to replicate and amplify the genetic material of viruses to easily recognizable levels. It is more sensitive than an antigen test.
This product is not only the first home test to combine influenza and COVID, it is also the first home flu test approved for use in the United States. Susan Butler-Wu, a clinical microbiologist at the University of Southern California, Keck School of Medicine, said. “We’ve known for a long time that influenza has very poor antigenic performance,” she says.
According to the FDA, in symptomatic people, Lucilla’s test correctly identified 88.3% of samples positive for SARS-CoV-2 and 90% of samples positive for influenza A. (This test was even better at detecting samples that were negative for these viruses. It was at or near 100% accurate. This is because false negatives give people a false sense of security. is important.)
The test also confirmed that 99.9% of the samples were negative for influenza B, but these strains have not been circulating in sufficient quantities for researchers to conduct clinical studies. Data is incomplete. Lucira should continue to collect data on influenza B from the FDA.
Lucira’s test uses a technique called Loop-Mediated Isothermal Amplification (LAMP), which is slightly different from PCR.it’s like [PCR’s] cousins,” says Butler Wu. PCR cycles samples at several different temperatures to amplify genetic material. In contrast, LAMP can be done at one temperature, so the processing equipment is simple enough for home use. is included.
FDA emergency approval allows COVID vaccines, medicines and tests to enter the market after 2020. These approvals are separate from the public health emergency that the Biden administration plans to end in his May, so Lucilla’s testing will not be revoked at that time.
It’s still unclear how Lucira’s bankruptcy will affect the availability of that product.The company was making some products in hopes of getting approval A test kit that will be available for sale, the spokesperson said. Scientific American. Lucira seeks to sell its business under Chapter 11 in order to resume manufacturing products. This also includes a COVID-only LAMP-based home test, and while the company has yet to reveal when the new combination test will begin or where it will be sold, it’s possible that his at-home COVID-only tests are available from Amazon and their website.
Lucira has also not announced pricing for the at-home product, but healthcare providers can purchase it for $99. According to Lucilla’s online store, Canadian consumers were able to purchase it for 98 Canadian dollars (about $72). By contrast, Abbott Laboratories’ popular COVID antigen test, BinaxNOW, costs about $12 per test. However, for antigen testing, the FDA recommends using multiple assessments at two-day intervals, depending on a person’s symptoms and exposure to the virus, which increases total costs.
One of the benefits of a test that distinguishes between COVID and influenza is that it helps doctors find the right treatment quickly. “For the flu, I might buy Tamiflu. [COVID], may become Pax Rovid,” says Butler Wu. “So having that information is very helpful.”
Getting tested at home and getting the news can shorten the usually slow diagnosis and treatment timeline, says David Pieper, a medical microbiologist at Yale University School of Medicine. “Many of these drugs are very time-sensitive and should be started within a certain number of days after the onset of illness,” he says. When the virus isn’t circulating, it may be better not to test for flu at all, Pieper warns.
The surge in home testing during the pandemic has changed the way both patients and doctors approach diagnosing and treating infectious diseases, Pieper says. Before the COVID epidemic, the only equivalent FDA-approved home test was for HIV. Tests for strep throat and respiratory syncytial virus (RSV) are currently in development. “I think it really changed expectations,” Pieper says. “This clearly shows that patients can do these things at home.”
