Posted On: 11/19/2020 4:37:07 PM Posted By: Crunch55 Many countries besides the US are using Antigen tests for mass testing. FDA just approved a Antigen home test yesterday requiring the test to be recorded. The home test just authorized by the FDA is not an antigen test, it is a Molecular Diagnostic Test that detects SARS RNA. Your product is a rapid, single-use molecular diagnostic test kit for the qualitative detection of SARS-CoV-2 RNA from self-collected nasal swab specimens that contains all the components required to perform testing. To use your product, SARS-CoV-2 nucleic acid is first eluted and lysed from nasal swabs that are inserted into the Sample Vial. The eluant then enters into the Test Unit where the nucleic acid is then reverse transcribed (RT) into cDNA followed by loop mediated isothermal amplification (LAMP) and detected by the Test Unit as a color change. Test results are displayed on the Test Unit via LED indicators. The Lucira COVID-19 All-In-One Test Kit includes the following materials or other authorized materials: Sterile Nasal Swab, Sample Vial, Test Unit, Batteries, Plastic Disposal Bag. https://www.fda.gov/media/143810/download https://www.fda.gov/media/143810/download