- Respiratory GenBody COVID-19 Ag
GenBody COVID-19 Ag is a rapid test for the qualitative detection of nucleocapsid antigen from SARS-CoV-2 in nasal swabs from individuals suspected of being infected with SARS-CoV-2 by their healthcare provider within the first 6 days of onset of symptoms or from individuals without symptoms or for serial screening. Emergency Use Authorization (EUA) approved.
Catalog Number: COVAG025-NU
In the USA, 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, 42 U.S.C. §263a, that meet requirements to perform moderate, high or waived complexity tests. This test is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation. This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens. In the USA, 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 the virus that causes COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. §360bbb- 3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
Support & Documents
The GenBody COVID-19 Ag product has been granted a shelf-life extension by the FDA. GenBody has received FDA approval to apply the new expiration dating to product in the field. Therefore, the kits that you have received have a longer expiration date than what is printed on the product labeling. The product can continue to be used until the new expiration date.
Nasal Swab sample type can be used with GenBody COVID-19 Ag.
It is not recommended to use transport media with nasal swabs.
Yes, the GenBody COVID-19 Ag kit includes 1 positive and 1 negative control swab.
It is suggested to use CPT 87811, and for the CLIA waiver, add a QW designator.