GenBody COVID-19 Ag Home Test

The GenBody COVID-19 Ag Home Test is a visually read lateral flow immunoassay for rapid, qualitative detection of SARS-CoV-2 nucleocapsid protein antigen from anterior nasal swab specimens. It is intended for non-prescription home use by individuals aged 14 years or older testing themselves, or by adults testing individuals aged 2 years or older, for detection of COVID-19 in people with signs and symptoms of infection.

The device uses mouse monoclonal antibodies to SARS-CoV-2 nucleocapsid protein coupled with colloidal gold to detect antigen. The test strip contains a Test line and Control line; results are read visually within 15–20 minutes. The only technical difference from the predicate (CorDx Tyfast) is the development time: 15–20 minutes versus 10 minutes; this difference does not impact technological characteristics, intended use, safety, or effectiveness.

Standards referenced include CLSI EP17-A2 (detection capability), EP07-Ed3 (interference testing), EP34 (extended measuring interval), EP12-A2 (qualitative test performance), EP05-A3 (precision), and ISO 10993 series (biological evaluation). FDA's nonbinding recommendations for SARS-CoV-2 antigen test premarket validation and ISO 11135:2014 (ethylene oxide sterilization) are also cited.

The GenBody COVID-19 Ag Home Test is substantially equivalent to the CorDx Tyfast COVID-19 Ag Rapid Test predicate (K240728) because both are qualitative lateral flow immunoassays for anterior nasal swab detection of SARS-CoV-2 antigen in OTC home-use settings with identical intended use, classification, and performance characteristics. Clinical data from 1,096 subjects demonstrate 86.2% positive percent agreement and 100% negative percent agreement with RT-PCR reference; the device shows robust analytical performance, no cross-reactivity or interference, and successful lay-user operation in usability testing.