The Rapid SARS-CoV-2 Antigen Test Card is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2.
- Lateral flow assay
- Detect SARS-CoV-2 nucleocapsid protein antigen
- Rapid results within 15 minutes
- For use with direct anterior nasal and nasopharyngeal swab specimens
- Detects all known COVID-19 variants
- Comfortable lower nasal specimen collection
- 2 COVID-19 test cards
- 2 Sterilized Swabs
- 2 Extraction Buffer Tube
- 1 Tube Holder
- Instructions for use
- 82.7% Sensitivity
- 99% Specificity
This product has not been FDA cleared or approved, but has been authorized by FDA under an EUA; This product has been authorized only for the detection of proteins from SARS- CoV-2, not for any other viruses or pathogens; and, 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 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.
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