It's an FDA power play: They say that any test that can affect people's lives has to be performed in a certified lab by certified techs. (But home pregnancy tests don't affect people's lives?)

This is reasonable for diagnostic tests, like the PCR SARS-COV2 test. But the lower sensitivity test strips should be considered a public health tool, and FDA should create another certification strategy for them: So they can be verified as able to detect the ability to infect others reliably. That way, we don't get flooded with a bunch of worthless strips or totally fake strips.

We also need a change so the viral load value gets reported to doctors and public health when somebody does take a PCR or other high-sensitivity test. The labs actually know this right now! They are just forbidden to report it, but it would be a very valuable tool for doctors, public health tracers, and patients. Most PCR tests are performed on the down side of viral load, when people are not contagious anymore. It's crazy to hide the progress of an infection. Maybe even criminal.