The detailed methods found in this article are the official Instructions for Use (IFU) as approved by the FDA. The test utilizes Biomeme’s M1 Sample Prep Cartridge for RNA extraction, Biomeme’s SARS-CoV-2 Go-Strips assay, and Biomeme’s portable Franklin™ Real-Time qPCR Thermocycler. Franklin’s companion mobile app, Biomeme Go, scans tests, runs your PCR experiments online or offline, and is used to quickly interpret your test results while conveniently syncing your data to the Biomeme Cloud.
The most recent version of the Biomeme SARS-CoV-2 Instructions For Use (IFU), approved by the FDA, is attached below. This version of the IFU for labs located in the U.S. or any other country, except for Canada, is regulated by the FDA.