GenBody
COVID-19 Antigen Test
25 Test Kits

Description

Point of Care COVID-19 Antigen Test

The GenBody is a lateral flow immunochromatographic assay intended for the qualitative detection of the nucleocapsid and RBD protein antigen from SARS-CoV-2 in direct anterior nasal swab specimens collected from patients within first 6 days of symptom onset. This point-of-care antigen test renders test results in :15 min. For in vitro diagnostic use only.

Authorized for use only in-patient care settings, this product is for licensed medical professional use only.

Clinical Performance

• Sensitivity: 92.31%
• Specificity: 99.04%

Manufacturer’s Statement:

• This product has not been FDA cleared or approved, but has been authorized by FDA under an EUA for use by authorized laboratories certified under the CLIA that meet the requirements to perform high or moderate complexity, or waived tests.
• This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens.
• 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. § 360bbb3(b)(1), unless the declaration is terminated or authorization is revoked sooner.