FDA Grants EUA for OTC Triple Test for COVID-19, Influenza A & B: Daily Dose

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Last week, we reported on the US Food and Drug Administration (FDA) granting emergency use authorization (EUA) for an over-the-counter (OTC) triple combination antigen test for influenza and COVID-19.

The decision

The SpeedySwab COVID + FLU A&B Antigen Self-Test (Watmind USA) is intended for use at home or at the point of care, can simultaneously detect COVID-19, influenza A, and influenza B in 15 minutes.

The SpeedySwab test is authorized for self-administration by adults and for use by adults for children aged 2 years and older who have symptoms of COVID or flu. The step-by-step process for in-home testing mirrors that for COVID-19 home antigen tests currently available. The test kits are produced in 1, 2, 4 and 25-pack options. The test will detect the presence of proteins from SARS-CoV2 variants and subvariants but will not discriminate among them.

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