YEP! Home kits are not even close to being regulatory approval to be used as clinical diagnostic devices. The Abbott testing system is actually FDA approved, as a means of detecting the COVID-19.
Will home test kits, when finally available, be a better "screener" than a digital thermometer? The blood antibody tests cannot detect the virus until 5 or 6 days after the person is infected. Will DECN's impedance-based test do any better? NOBODY KNOWS!