RE:RE:Biden says US will order 300 M covid rapid tests In the US the FDA makes a distinction between authorization and approval. Approval is a much more rigorous and time consuming process thus the EUA process and designation. There have been very few covid tests of any kind that have been approved ...virtually all have been authorized under the EUA.
As for the difference between nasal and saliva samples there were very companies that explored the use of saliva as a sample ...a handful at best ....the only one in Canada, SONA, pulled their test from HC review when it looked like it was going to be rejected. Nasopharyngeal and nasal swabs have traditionally been the standard for respiratory infections so it's no surprise that virtually all test devices around the world were designed with this in mind.
https://www.contagionlive.com/view/confirming-accuracy-of-saliva-testing-for-covid-19
The BD Veritor Test was approved by HC in early October of 2020 and had a sensitivity of 83.9% ...below that of AcuVid. As for the improvements ...great for them. That in NO WAY diminishes the potential for AcuVid to be both given FDA EUA authorization and to be a significant player in the world of covid testing ....a need well beyond the borders of the US.
TheeRook wrote: That is because compared to the current at-home tests the LOD of the saliva tests are not good enough. A negative test does not mean you do not have Covid.
The latest FDA approved 187 TCID50/mL much better than the first generation of Rapid Tests from early 2020.
BD Veritor™ At-Home COVID-19 Test
Table 6: BD Veritor™ At-Home COVID-19 Test Limit of Detection
Estimated LoD 1.87 x 10^2 TCID50/mL 19/20 95%
wm23four wrote: Biden announces US will commit $2B to purchasing 300M covid rapid tests. Sure would be nice if THRM's rapid saliva test could get FDA EUA approval soon so they could get a slice of this. No saliva tests have FDA approval yet as far as I know. Just think what the demand will be when/if they get approval. The sooner the better. No guarantees on approval, But I sure like the odds. IMO the risk/reward at current share price is well worth it.