View the informational brochure HERE
Kit contains 20 test cassettes, 20 swabs and 2 bottles of buffer solution
FDA EUA & CE MARKED SCoV-2 Ag Detect™ Rapid Test is a lateral flow chromatographic immunoassay intended for the qualitative detection of the SARS-CoV-2 nucleocapsid protein antigen in direct anterior nasal swab specimens from individuals who are suspected of COVID-19 by their healthcare provider within the first 5 days of symptom onset when tested at least twice over three days with at least 48 hours between tests and from individuals without symptoms or other epidemiological reasons to suspect COVID-19 when tested at least three times over five days with at least 48 hours between tests. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. § 263a, that meet the 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 not been FDA cleared or approved, but has been authorized by FDA under an EUA for use by authorized laboratories;
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.