Highlights include: • Detects SARS-CoV-2 nucleocapsid protein antigen • Rapid results in 15-20 minutes • Identifies acute infection with a 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 GenBody COVID-19 AG is intended for use by medical professionals or operators trained in performing tests in point of care settings. The GenBody COVID-19 AG is only for use under the Food and Drug Administration’s Emergency Use Authorization.
