Single test to distinguish COVID-19, flu viruses gets FDA approval

WASHINGTON - Is it COVID-19? Could it be a cold or the flu? Waking up with a cough or runny nose is unfortunate, but it can be particularly alarming amid the ongoing coronavirus pandemic. 

In response, U.S. health regulators have granted an emergency use authorization for a test that can detect the novel coronavirus, multiple types of flu viruses and a respiratory virus using a single nasal swab. 

Abbott Laboratories, the company behind the test, on Friday announced the approval from the Food and Drug Administration. It’s called Alinity m Resp-4-Plex, and the company said the single test can detect and distinguish COVID-19, flu A, flu B, and another respiratory virus called respiratory syncytial virus (RSV).

Abbott, a health care and diagnostics company, has developed several COVID-19 tests that have been authorized for emergency use since the onset of the pandemic.

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Influenza types A and B are known to cause seasonal flu epidemics annually in the U.S., while RSV is a common respiratory virus that typically causes mild, common-cold-type symptoms — though it can be severe for both young infants and older adults. Abbott said these four viruses share a variety of common symptoms, including cough, fever and fatigue, which can make distinguishing one from the other challenging.

The company said simultaneous testing for infectious diseases "will not only increase convenience and decrease discomfort for the patient," but it aims to help stretched healthcare workers and save testing supplies that are in high demand. 

"The need for a combination of testing methods in different settings has never been more clear," said Andrea Wainer, Abbott Rapid and Molecular Diagnostics’s executive vice president. "This newest test will allow for fast and efficient diagnosis and triage of patients who present with respiratory symptoms so they can be given the right care."

FILE - A physician’s assistant prepares to test a drive-through patient for COVID-19 on April 21, 2020 in Santa Ana, California. (Photo by Leonard Ortiz/MediaNews Group/Orange County Register via Getty Images)

Abbott said the test will serve as an important tool because the viruses cause similar symptoms but require different treatment approaches. 

It uses Polymerase Chain Reaction (PCR) technology, known for its high sensitivity in detecting infectious diseases.

Earlier this week, the FDA granted emergency approval for a fourth at-home COVID-19 test in the U.S., allowing patients to rapidly test themselves without having to send a sample to a laboratory for analysis.

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This story was reported from Cincinnati.