RE:Cross ReactivityAlthough that's a nice smoke and mirrors effort at explaining why the FDA hasn't cleared the test its fundamentally wrong.. an antigen test does not test for "antigens of othe respiratory viruses" it tests for "proteins" in the virus... but nice try at clouding the issue.. LOL.. Smokey1958 wrote: From what I can gather, based on Robs' most recent interview, the holdup with the FDA is they want to make sure AcuVid does not detect the antigens of other respiratory viruses that would lead to false results. I'm not sure I've read anywhere of that being a neccessity for other authorized tests but it is highly unlikely that others would have been able to sidestep this issue. The reason for this, as an example, is that at an early age we are all getting infected by and creating antibodies for the most prevalent coronavirus ...the common cold.
The challenge, which I expect is just one of time, is to access other viral antigens (?)and to carry out the tests to make sure the test (the assay of the test which is antigen specific) that would be protein specific is not being influenced by or reacting to the antigens of other coronaviruses. Nope wrong again.
To me this suggests good news and that AcuVid has met all other criterion and this is merely the last step to insure the accuracy of AcuVid and in doing so make way for authorization. Imho the other reason that AcuVid is in line for authorization is that there has been NO PROBLEM thus far of it detecting variants. That means the assay choice was one that detects antigens that are common to all the variants. Nope..! With such a strong showing thus far it's hard to imagine AcuVid not being able to detect future variants.
GLTE ...holding patiently!!! An NR based on the CE mark would be timely right about now!!!