SONA’s Test Results Excellent under new FDA POC Guidelines Sona was the first company to have to follow the new FDA POC Antigen Guidelines. Under the new guidelines a non laboratory professional has to also administer the tests (See Section 8 - FDA below) Sona had 3 laboratory trained professionals and 2 untrained people like me and you administer the tests. Under these new guidelines 84% Sensitivity and 90% Specitivity are excellent!!!
Remember Quidel & BD got 84% & 80% Sensitivity under their own clinical laboratory settings, that are not 3rd party validated. SONA got 96% Sensitivity 3rd party results from MRIGlobal. Let's compare apples to apples. Folks this news is excellent!!
8) Studies to support Point of Care claim, as applicable: [If the device is intended for near patient testing or Point of Care (POC), please provide data to demonstrate that non-laboratory personnel can perform the test accurately in the intended use environment (i.e. a non-laboratorian healthcare provider accuracy study). Please also provide data to demonstrate robust use of your device for near patient testing (e.g., as applicable, studies to demonstrate the impact of adding different volumes of sample, different volumes of reagents, incorrect order of sample or reagent application, etc.).]