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FDA approves the first flu and COVID at-home test, but the company behind it is bankrupt

Coronavirus (Via Alex Cruise/Shutterstock)

The U.S. Food and Drug Administration (FDA) gave the green light for the first at-home test that checks for both flu and COVID-19, as announced on Feb. 24. But the company behind the test recently declared bankruptcy, raising questions about its ability to make and distribute the test widely, according to STAT.

This single-use test kit, created by Lucira Health based in California, can tell apart the two main types of flu viruses (influenza A and B) and spot the COVID-19 virus. It works by using a nasal swab and gives results in 30 minutes or less. It’s meant for people who show signs of a respiratory infection.

The FDA statement said, “In people showing symptoms, the Lucira COVID-19 & Flu Home Test accurately identified 99.3% of negative and 90% of positive Influenza A samples, 100% of negative and 88.3% of positive COVID-19 samples, and 99.9% of negative Influenza B samples.”

The FDA issued an emergency for a new test that detects flu and COVID-19 (Via Jeremy Johnson/Getty Images)

The FDA pointed out that because cases of influenza B are very low compared to influenza A, Lucira had to use lab-grown “contrived” viruses to show its test could detect influenza B. The FDA gave emergency approval based on this, but for full approval, Lucira needs to test patient samples to confirm it can find influenza B reliably in real life, the FDA stated.

All rapid tests can give false results sometimes — either saying someone has the virus when they don’t (false positives) or missing the virus when it’s there (false negatives). But Lucira’s test uses “nucleic acid amplification” tech, which boosts the virus’s amount in the swab, making it more likely to catch both flu and COVID-19 than a regular rapid test, according to STAT.

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