I read the letter and some info at the Lucira website. This isn’t an ingested or injected product; it is simply a shallow nasal cavity swab. It also is not an antigen-based test; rather, it is " a molecular or nucleic acid amplification test (NAAT).
My reticence to use this or any recent biopharm product isn’t necessarily with Lucira. The FDA has no credibility whatsoever and the fact that they continue to leverage the C19 EUA mechanism to either get information from our bodies or other things into our bodies (this is a potentially an inhalable/absorbable product) is not surprising.
Below is excerpt from the authorization letter to Lucira.
Link to the authorization letter:
https://www.fda.gov/media/165688/downloa
Lucira announced in early December 2022 (like four months ago) a joint clinical study in Canada. (Note: I don’t have time to dig any deeper to find out what the clinical testing requirements are for a nasal swab diagnostic device.) Suffice to say that with an EUA, all required testing for regular FDA approval has not been completed.
(NOTE: The webpage title and link is correct but the subtopic headline for STD assays is obviously a mistake.)
This study will be or is being conducted at Loch Lomand Villa, a large senior center in Saint Johns, New Brunswick. “With 99% accuracy and within 30 minutes, institutions will simultaneously and accurately test residents, health workers and visitors for COVID-19 and Flu A/B.”
Link to the senior center:
https://lochlomondvilla.com/
I wonder whether EVERYONE who enters the facility will be required to swab.