My OPINION only - Why AcuVid will get FDA EUA In My OPINION….Here is why I believe AcuVid is assured to be granted FDA EUA
Clinical Studies
- AcuVid US Clinical Study:
- PPA 80.3% / NPA 98%. -
- US Sample Size: 230+ samples
- AcuVid Brazilian Clinical Study: (If FDA accepted Diasorin’s International results, so should they accept AcuVid’s international results)
- PPA 85.7% / NPA 97.8%.
- Brazil Sample Size: 260_ Samples
- AcuVid Blended Clincials: -
- PPA 83% / NPA. 97.9%.
- Total Sample Size: 490+
FDA EUA CLINICAL MINIMUMS
- US FDA EUA Requirements:
- PPA: 80.0% / NPA 95% Or Higher
Competition Clinicals Comparisons
- Abbott’s Binax NOW COVID 19 AG Test (approved Dec 16, 2020) -
- PPA 84.6% / NPA 98.5%. - (long before Delta, Omicron and BA-2 Omicron).
- US Sample Size. 460
- Diasorin LIAISON SARS-CoV-2 Ag (approve March 26, 2021) - Combined US & European Clinical Results
- PPA. 84.4% / NPA 99.5% (before Delta, Omicron and BA2 Stealth Omicron)
- US & EUROPE sample Size: 399 ( 2 labs in US & 2 Labs in Europe)
Cross Reactivity Studies
- Cross Reactivity Studies - Nasal- borne viruses & bacteria (like all the other antigen tests).
- ADDED Cross Reactivity Studies - Mouth-borne viruses & bacteria
Alternative Rapid Testing Solutions Being Accepted for FDA EUA
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AcuVid benefits
- Meets Standards: Meets FDA EUA PPA and NPA results, cross reactivity tests & WHO Variants of Concern test standards
- Affordable: cost similar to other Covid-19 Rapid Antigen Nasal Test solutions
- Production: Meets the November 2021 Guidance for 500K tests per week