UPDATING MY DD - 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 Clinicals: -
- PPA 83% / NPA. 97.9%.
- Total Sample Size: 490+
FDA EUA Clinical Studies
- 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
CUE Health (https://www.cuehealth.com)
FDA EUA. March 5, 2021.
Rapid Antigen Nasal Test
Detect (https://detect.com)….
FDA EUA. October 29, 2021.
PCR Nasal Test
MicroGem PCR Saliva Test with Machine. (NOTE: 8+ other Saliva PCR Tests with FDA EUA)
FDA EUA - April 19, 2022.
Machine: 10,000 Unites per year
Size: 33 pound machine
Testing time: 30 minutes
Test per Machine per Day: 28 per day / 700 per month (25 days operating X 28 tests a day)
Machine Cost: $8500
Cost Per Test: Machine cost is $12.14 first month, and then drops from there. PLUS the collection tube, buffer, pipette for sample collection is added, same items that make up AcuVid test…
Machine Test Process: 30 minutes / 1 at a time, over 14 hours a day
PCR-Type Test
INSPECT IR Breathalyzer Test
FDA EUA - April 14, 2022.
Machine: 20 in stock, 100 per week production
Size: Travel Suitcase Size
Testing Time: 3-5 minutes (including prep machine & patients)
Test Per Machine (14 hr day): 160 per day / 4000 per month (25 days operating X 160 tests a day)
Machine Lease: $30000
Cost Per Test: $7.50 per test
Machine Test Process: 3-5 minutes / 1 at a time, over 14 hour
PCR-Type Test
Challenges with InspectIR & MicroGEM Rapid Saliva PCR Test.
- Limited Production Capabilities - no way any of these can produce 500K per week or service 500K people per week on machine production
- Testing Process: 1 person at a time per machine…not simultaneous like lateral flow cartridges.
- Machine Cost $$$, Plus material costs (straws & nose clips, spit tubes, buffer solution, etc)
- Distribution: requires huge distribution to service 500K people per week
AcuVid benefits
- Meets Standards: Meets FDA EUA PPA and NPA results, cross reactivity tests & WHO Variants of Concern test
- Testing Process: Can test a lot of people at same time, simultaneously
- Affordable: cost similar to other Covid-19 Rapid Antigen Nasal Test solutions
- Production: Meets the November 2021 Guidance for 500K tests per week