Ellume’s COVID-19 Home Test Receives the US FDA’s EUA as First Over-the-Counter Diagnostic Test

Shots:

• The US FDA has granted EUA for Ellume COVID-19 home test for non-prescription home use in symptomatic and asymptomatic individuals aged ≥2yrs.
• The data submitted to the US FDA from an independently run, simulated home-setting clinical study of 198 subjects aged 2-82yrs, demonstrated 96% accuracy including 95% overall sensitivity & 97% specificity vs emergency use-authorized RT-PCR lab test
• The test’s core technology combines ultra-sensitive optics, electronic software to leverage digital immunoassay technology with next-generation multi-quantum dot fluorescence technology

Click here ­to­ read full press release/ article | Ref: GlobeNewswire | Image: MobiHealth News