RE:MRI GlobalNo one is disputing the MRI Validated results for SONA. From those results, further studies were needed, In which the deadline was missed and a two week extension added Looks like another extension is coming. SONA is too small a company to do all the work themselves and has to contract the work out or seek other third parties for assistance.
""Following consultation with MRIGlobal and the Food and Drug Administration, Sona will enter into independent clinical, in-field evaluation studies to generate the data to support its analytical and clinical data as part of the submission it will make to Health Canada and the FDA for emergency-use authorization (EUA) approval."" SONA got a PPA - 96 % and an NPA of 96% LOD 210
""Validation studies were also conducted in house to assess potential clinical performance of the test using 30 nasopharyngeal samples from healthy individuals who were presumed negative for COVID-19. Results from the study generated a specificity of 96 per cent (29/30) and a sensitivity of 96 per cent (28/29). All specimen samples tested generated negative results, except for one, generating the result of 96 per cent. To generate the sensitivity data, the remnants of each negative sample were spiked with gamma-irradiated COVID-19 virus and the tests rerun to determine the positive results, generating the result of 96 per cent."" Critical Thinking and comprehension is required here and an understanding of molecular bioscience
The FDA wants the AntiGen Sympomatic Test to be close to full proof at catching all Symptomatic Covid patients. Hence the HIgh Performance bar for the PPA.
SONA could have save alot of time if they just followed FDA protocols with early data and used an FDA Approved
MD and the authorized ThermoFisher Scientific TaqPath test. NothinButTime wrote: MRI Global
For decades, MRIGlobal expertise has led biosafety and biorisk management program development in the U.S. and internationally.
“MRIGlobal offers government and commercial clients services that include assay design and clinical development through regulatory submission. We provide extensive research and product development expertise; facilities, analytical services, clinical trial site, and clinical trial services and support; and regulatory guidance to support FDA submission filings.”
This is who validated Sona’s test. A top notch lab trusted by the US Military and the Pentagon. A lab that helped fight the Ebola crisis, has extensive experience in obtaining FDA approvals, and received a grant from Bill Gates.
Who do you trust? These fine scientists who have top notch expertise in testing devices and biological threats, or some random guys who say the company has nothing.
As David said, “we have an antigen test that works, which is an extraordinary thing”.
My money is on the guys that keep their heads down and get to work. Less talking, more proving. Show and prove. That’s all this company has done.