ADO in their discussions with TGA could go through the following...

ADO in their discussions with TGA could go through the following points:

1. Per MS - the ADO test detects the N protein (Nucleocapsid Protein) of the Sars Covid-2 virus (Covid-19).
2. The test has high affinity and sensitivity to this protein.
3. Th N protein is highly consistent in all Sars Covid-2 variants - the following paper could then be quoted as supporting this case https://www.frontiersin.org/articles/10.3389/fimmu.2021.719037/full . Structural Basis for SARS-CoV-2 Nucleocapsid Protein Recognition by Single-Domain AntibodiesQiaozhen Ye1, Shan Lu1 and Kevin D. Corbett1,2*1Department of Cellular & Molecular Medicine, University of California San Diego, La Jolla, CA, United States2Department of Chemistry and Biochemistry, University of California San Diego, La Jolla, CA, United States
4. The discussion section states - Here, we present high-resolution structures of three single-domain antibodies bound to defined domains of the SARS-CoV-2 N protein. Two sdAbs bind the N-terminal RNA binding domain, and one binds the C-terminal dimerization domain. All three sdAbs recognize highly conserved surfaces on the N protein, suggesting that they could be used to recognize SARS-CoV-2 infections in antigen tests. As SARS-CoV-2 transitions from an acute public health threat to an endemic phase, the ability to robustly detect and respond to infections and local outbreaks will remain important, especially in the developing world. Development of antigen tests with the sdAbs characterized here, which can be produced at high levels in E. coli and recognize the highly-abundant N protein with high specificity and affinity, can significantly aid this effort.
5. Th ADO test works in exactly the same way and therefore is very highly likely to work for all variants of Covid-19 because of the consistency of the N protein in the virus.
6. Unlike PCR the ADO test is highly unlikely to have the false negatives (bad news) of PCR and other tests that do not test for the N protein.
7. Point out the Doherty already have done the tests on the assay.

With this type of information TGA should have the key question answered.