The Food and Drug Administration has approved an at-home test that can detect and discern between COVID-19 infection and two strains of the flu, Influenza A and B, continuing the shift from clinical to home-diagnostic care that blossomed during the height of the pandemic.
Manufactured by medical technology company Lucira Health, the test uses a nasal swab to detect the presence of a virus in 30 minutes.
The emergency use authorization, announced Friday in a news release from the Food and Drug Administration, followed a surge in respiratory cases in the fall that drove up hospitalizations nationwide and in Allegheny County. National and local respiratory cases now are trending downward.
Two days prior to the approval, Lucira filed for Chapter 11 bankruptcy, citing the hope for approval in August, prior to flu season.
The single-use test is currently only available for health care providers to purchase, at $99; a Lucira spokesperson said it is not yet known when consumers can buy the device more widely. The spokesperson said the test is expected to be at least partially, if not fully, reimbursable by insurance, depending on the consumer's plan.
As of Jan. 15, all private health insurance members are eligible to receive up to eight at-home COVID tests at no cost.
The Lucira device uses a technology called RT-Lamp, which is similar to a polymerase chain reaction test and thus more sensitive and accurate than a typical COVID antigen test. It works like the latter in that users swab their noses and swirl the sample into a solution connected to the device.
According to Lucira clinical trials, the test accurately predicted 88.3% of positive COVID and 100% of negative COVID samples, as well as 90.1% of positive and 99.3% of negative Influenza A and 99.9% of Influenza B samples.
This past flu season saw the dominance of the Influenza A strain with few Influenza B cases; the FDA news release said Lucira intends to continue testing to validate that portion of the device's capabilities.
Health care providers have been using a similar test for close to a year, said Dr. Amy Crawford-Faucher, a family physician and the vice chair for the Allegheny Health Network Primary Care Institute and the Department of Family Medicine.
The Lucira test, designed for use by anyone age 14 and up and done by an adult for those ages 2 to 13, enters the market at a time when consumers are increasingly accustomed to at-home diagnostics, from tests to telehealth appointments.
"The pandemic has made us think in such different ways about how patients can access health care," said Dr. Crawford-Faucher. She said at-home tests are becoming more common and accessible, and can help increase access to care for those traditionally left out due to high cost, no insurance or lack of transportation to medical facilities.
"[Friday's] authorization of the first OTC test that can detect Influenza A and B, along with SARS-CoV-2, is a major milestone in bringing greater consumer access to diagnostic tests that can be performed entirely at home," Jeff Shuren, director of the FDA's Center for Devices and Radiological Health, said in the news release about the authorization.
The at-home testing method is also more efficient, said Dr. Crawford-Faucher, because patients who tests positive for COVID can inform their doctors, who can personalize treatment instead of giving general guidelines for respiratory symptoms.
The cons of at-home testing involve patient use and determination of results.
"It's a good test," said Dr. Alan Wells, the medical director of UPMC Clinical Laboratories and a professor of pathology at the University of Pittsburgh School of Medicine. But patients often assume top accuracy despite some decreased sensitivity compared to traditional lab-run RT-PCR.
And as the pandemic drags on, most people are testing less frequently for COVID, and are less worried about exposure.
"This is a new behavior of testing yourself at home. It was taken up while people were still worried about not catching it and exposure, but that seems to have waned," said Dr. Wells. "All available vendors are reporting fewer sales, and we still have no idea what will happen in May when the emergency use authorization ends, because these tests will no longer be free or reimbursed."
In Allegheny County, respiratory virus cases (RSV, COVID and flu) were the highest they have been since 2013, the earliest year for which the county has data.
As of Feb. 18, the 2022-2023 flu season saw more than 14,000 cases and 64 hospitalizations. By comparison, last year's flu season saw about 2,000 cases with 20 hospitalizations.
Following the flu spike, doctors now are seeing hospitalizations from rogue viruses, unrelated to the respiratory trifecta that dominated hospitals in November.
"Still, the majority of people with symptoms of flu have neither COVID nor influenza," said Dr. Wells. "They have other viruses."
Dr. Crawford-Faucher said the same.
"We've seen so many non-COVID, non-flu, non-RSV viruses that have made people quite sick and brought them into the hospital in the past month," she said. "We need to keep our clinical antenna up for the next month."
Regardless of the respiratory virus, Dr. Wells said the treatment is much the same for an overall healthy person who is not high-risk: "Go home, isolate yourself, get better, and if you have trouble breathing, see your doctor."
He believes testing will go by the wayside and worried that this particular one would not be useful for a majority of people, due to its cost and a general dip in demand. "I have a feeling that this is a splash that won't have many ripples," he said.
Dr. Crawford-Faucher wondered if the FDA authorization for the Lucira COVID-flu test would be "the tip of the iceberg" for other companies to create their own devices and ultimately drive the retail price down. "Overall, it's a positive thing if more tests are developed," she said.
And while Lucira Health filed for bankruptcy so close to the test's emergency authorization, its leadership remained optimistic about its ability to push forward in the space of at-home health.
"We regret that we had no option but to file for Chapter 11 bankruptcy and that this occurred days before we received regulatory authorization," said Lucira Health president and CEO Erik Engelson in a Monday news release. "We remain confident in the role that the new test can play in future respiratory seasons and are honored to have received the first authorization for such a home test. We appreciate the diligent work of the FDA team as they refined requirements during the review cycle."
