RE:RE:...FDA FOR FAST POINT OF CARE PCR COVID-19 SALIVA TEST
From my various post on CEO CA on this subject…
MICROGEM’S THERANOS-TYPE CLINIC MACHINE - SALIVA, NOT BLOOD.
MicroGem Saliva PCR Test uses the same spittoon, pipette, buffer and then a big machine to rune the analysis . Check ou the IFU: On the FDA Molecule PCR Tests Site - https://www.fda.gov/media/157754/download. For a moment there I thought it was the Theranos machine revamped to evaluate saliva. LOL
Not real competition. Costly"Theranos-Type" machine. LOL
MICROGEM’S US CLINICAL - NOT IMPRESSIVE OR ACCURATE FOR PCR TEST
Plus for a PCR Test, their stats aren't much better than AcuVid blended PPA 83%/NPA98% (US & Brazil Clinicals). Looks like MicroGem with a Pricy$$. Machine are Positive Percent Agreement (PPA) 87.2% CI = 74.8% - 94.0%. Negative Percent Agreement (NPA) 97.2% CI = 90.4% - 99.2%.
NOW CLINICS CAN USE PCR MACHINE & NOT SEND TO LAB
Check out the FDA EUA PCR Molecular Tests...there are about 274 lines, and I believe about 8+ are PCR saliva tests that run through machines at labs, that clinics send their samples too. However, those same machines can be brought into a clinical like this and a staffer can be trained on how to use it. This MicrGem machine must be easy for these onsite clinical technicians to run. No real difference. Some of the clinics I went to had these PCR machines, so not lab was required. I got results within the hour. None the less, like the Breathalyzer, this MicroGem PCR Saliva Test..not real competition... and one at a time...versus 50 rapid antigen saliva tests run simultaneously
FDA EUA PCR MOLECULAR SITE (https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-molecular-diagnostic-tests-sars-cov-2)
1) BioFire Defense, LLC (Saliva PCR) ,
2) Thermo Fisher Scientific Inc (Saliva PCR),
3) Yale School of Public Health, Department of Epidemiology of Microbial Diseases (Saliva PCR),
4) PerkinElmer, Inc. (Saliva PCR),
5) University of Illinois Office of the Vice President for Economic Development and Innovation (Saliva PCR)
6) Gravity Diagnostics, LLC (Saliva PCR)
7) Southern California Permanente Medical Group. (Saliva PCR)
8) The Mount Sinai Hospital, Center for Clinical Laboratories (Saliva PCR)
…and more