GENBODY COVID-19 ANTIGEN RAPID TEST

Regulatory Status: FDA EUA Authorized – this test has not been FDA cleared or approved but has been authorized by the FDA under an EUA for use by authorized laboratories. CLIA WAIVED
Contents: Test device (25), Extraction solution (2), Extraction Tubes (25), Dropper Tips (25), swabs (25), Positive control swab (1), Negative control swab (1) each, Instructions for use (1) Quick Reference Instructions (QRI) (1)
Determinations: Detection of the SARS-CoV-2 nucleocapsid protein antigen
Storage Requirements: 2° – 30° C
Processing Time: Approximately 15 Minutes

Description

Backed by the NIH, the GenBody Covid-19 Antigen Test, The GenBody COVID-19 Ag test is a rapid, qualitative immunochromatographic assay for the determination of the presence of SARS-CoV-2 antigens in human nasopharyngeal or anterior nasal swab specimens. The test strip in each device contains mouse monoclonal antibodies to the nucleocapsid protein (NP) of SARS-CoV-2.

Features:

Detects SARS-CoV-2 nucleocapsid protein antigen
Rapid results in 15-20 minutes
Nasopharyngeal swab specimen collection
Identifies acute infection with a 91.1% sensitivity and 100% 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.