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FDA greenlights nonprescription test for Covid, flu and RSV

The test, from Labcorp, allows people to test for three respiratory viruses at once.
A driver places a swab into a vial at a free drive-thru Covid-19 testing site in the parking lot of the Mercy Fitzgerald Hospital in Darby, Pa., on Jan. 20, 2022.
A driver places a swab into a vial at a free drive-thru Covid-19 testing site at Mercy Fitzgerald Hospital in Darby, Pa., on Jan. 20.Matt Rourke / AP file

It's a question that's plagued Americans since the start of the Covid-19 pandemic: Do I have Covid or the flu?

It may be easier to answer soon: On Monday, the Food and Drug Administration authorized the first nonprescription test that can detect Covid, influenza A and B, as well as respiratory syncytial virus, or RSV.

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The test, manufactured by North Carolina-based company Labcorp, allows people to collect their own nasal swab sample at home and then ship it to one of Labcorp's labs to be analyzed.

People can purchase the test online or at a retail store, and the turnaround time for results is typically one to two days once the sample has arrived at the lab, Labcorp told NBC News in a statement.

Tests that can detect multiple respiratory viruses already exist, but they usually require people to go to a health care provider, who collects the nasal swab sample from the patient and then sends it off to a lab to be analyzed.

Labcorp's newly authorized test removes some of the red tape, allowing Americans to collect a sample from the convenience of their own home.

A test that looks for Covid, flu and RSV is “sort of the Holy Grail,” said Dr. Michael Mina, a former Harvard epidemiologist who is now the chief science officer for eMed, a company that provides telehealth and at-home testing services. All are dangerous respiratory viruses that, in total, cause tens of thousands of deaths each year.

The test will likely remove barriers and increase access to testing, particularly in underserved populations where people may not be able to go into a clinic to get a test or in situations where people don't feel comfortable getting tested, said Jennifer Smith, an epidemiologist at the University of North Carolina at Chapel Hill’s Gillings School of Global Public Health.

Labcorp's test is a PCR, or polymerase chain reaction test. This type of test works by detecting tiny snippets of genetic material from the viruses in question. A test kit costs $169, according to a Labcorp spokesperson Chris Allman.

Smith said the price tag wasn't surprising, noting that people are getting three tests in one.

She hopes the new test will lead to even greater advancements, including tests that can be taken at home and don't need to be shipped to a lab to be analyzed.

“Technology is advancing very quickly, and in due time, home-based point of care testing using PCR will likely be an option in the near future,” she said.

Matthew Binnicker, a clinical virologist at the Mayo Clinic in Minnesota, agreed, saying he wouldn't be surprised if "a true 'at-home' molecular test targeting Covid-19, influenza and RSV is available within the next 12 months."

The FDA said in a release that people ages 18 and older can collect their own samples while people ages 14 to 17 can collect their samples with adult supervision. Adults need to assist children under age 14, according to the agency.

Test results are delivered through an online portal, the agency said, with follow-up from a health care provider for positive or invalid test results.

While exciting, Smith, of the University of North Carolina, said there needs to be a focus by state and federal officials to implement systems that allow people who test positive to seek the appropriate care that they need.

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