GenBody Rapid COVID-19 Ag Test

The GenBody COVID-19 Ag point-of-care test is a lateral flow chromatographic immunoassay intended for the qualitative detection of nucleocapsid protein antigen from the SARS-CoV-2 virus.

Features & Benefits

• FDA EUA Authorized rapid antigen test
• Anterior nasal swab specimen collection for comfort
• Identifies acute infection with a 92.31% sensitivity and 99.04% specificity
• Selected by NIH for the Rapid Acceleration of Diagnostics, for US production of the GenBody COVID-19 Ag test
• Large manufacturing capacity and immediately available for distribution
• For use in the Point-of-Care setting

Disclaimer

The GenBody COVID-19 Ag test has not been FDA cleared or approved, but has been authorized by FDA under an EUA for use by authorized laboratories. The product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens; and, the emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.

Box Includes:

• 1 positive, 1 negative control swabs
• 2 bottles of extraction solution
• 25 test devices
• 25 extraction tubes
• 25 dropper tips
• 25 swabs
• 1 instructions for use

GenBody-IFU.pdf

GenBody-Fact-Sheet-for-HCP.pdf

GenBody-Fact-sheet-for-patients.pdf