GenBody COVID-19 Antigen Rapid Test Kit
Rapid detection of SARS-CoV-2 will play a key role in the global spread of the virus. Affordable and sensitive test that does not require an additional reader, with a processing time of 15-20 minutes.
- For use under an Emergency Use Authorization (EUA) Only
- For In vitro diagnostic use only
- For professional use only
Features
■ Detects SARS-CoV-2 nucleocapsid protein antigen.
■ Rapid results in 15-20 minutes
■ Anterior nasal swab specimen collection
■ Identifies acute infection with 92.31 % sensitivity and 99.04% specificity
■ For use in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance or Certificate of Accreditation.
■ The confirmed LoD for the GenBody COVID-19 Ag Test is 1.11 x 10 2 TCID50/mL
GenBody Competitive Advantage
■ Large manufacturing capacity and immediately available for distribution
■ Global sales and regulatory approval throughout Europe, Asia and South America
■ Selected by NIH for the Rapid acceleration of Diagnostics program, for the US production of the Gen Body COVID-19 Ag test
■ Made in the USA and South Korea
■ The GenBody COVID-19 Ag test detects the SARS-CoV-2 variants.
GenBody COVID-19 Ag Performance
Sensitivity: 92.31%
Specificity: 99.04%
GenBody COVID-19 Ag Kit
Package Unit: 25 Tests/Box
Kit Components:
- 25 Single use Test Devices individually Foil-Pouched
- 25 Single Use Pre-Foiled Extraction Tubes
- 25 Single Use Dropper Tips
- 25 Anterior Nasal Swabs
Storage Temperature: Between 35.6 to 86 degrees Fahrenheit
Expiration Date: 21 months from the date of manufacture