iHealth gets EUA for combination COVID-19/influenza at-home test

Covid Test Preschool Social

Diagnostics developer iHealth Labs has received an emergency use authorization (EUA) from the U.S. Food and Drug Administration for its 3-in-1 COVID-19/Flu A&B Rapid Test Kit for over-the-counter home use.

According to iHealth, the COVID-19/Flu A&B Rapid Test is a lateral flow immunoassay for the detection and differentiation of SARS-CoV-2, influenza A, and influenza B protein antigens. Results for COVID-19, influenza A, or influenza B are displayed in 15 minutes.

This test is authorized for nonprescription home use with self-collected anterior nasal swab specimens for individuals ages 14 years or older, or with adult-collected anterior nasal swab specimens from children two years or older. The firm notes in a statement that assistance from an adult is necessary for children between the ages of 2 and 13.

While COVID-19 and influenza may present with similar symptoms, the treatment for the two differs.

The iHealth COVID-19/Flu A&B Rapid Test is authorized for individuals with signs and symptoms of respiratory infection consistent with COVID-19 within the first four days of symptom onset when tested at least twice over three days, with at least 48 hours between tests.        

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