InvestorsHub Logo
Followers 24
Posts 2347
Boards Moderated 0
Alias Born 06/03/2012

Re: Kurt_Banoffee post# 95754

Thursday, 11/19/2020 11:47:08 PM

Thursday, November 19, 2020 11:47:08 PM

Post# of 104482

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

Join the InvestorsHub Community

Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.