RE:ARE WE WAITING FOR MIR OR FDA ? ANYONE KNOW ?
My understanding is that FDA has changed the requirements, so many companies have submitted test kits that have turned out to be bogus. So things are more stringent now.
First MedMira has to send kits for testing to an approved lab (or have they retested on certified test panels). Then those results with additional kits go to the FDA for additional evaluation. To pass, they need to achieve 90% (sensitivity) accuracy. I believe they have been averaging 95 to 97%. Someone posted that the product insert quoted 97.1%.
MedMira's science is rock solid, with the accurate detection of all 3 antibodies - IgA, IgG, and IgM. Just comes down to time for both MedMira and the FDA to complete the requirements. Given the rising COVID numbers in 40+ states, I am sure the FDA wants this done as soon as possible.