SCoV-2 Detect™ IgG Rapid Test
FDA Emergency Use Authorized and CE Marked

The SCoV-2 Detect™ IgG Rapid Test is an in vitro lateral flow chromatographic immunoassay intended for the qualitative detection of IgG antibodies to SARS-CoV-2 in human serum, plasma (sodium citrate, dipotassium EDTA and sodium heparin), venous whole blood (sodium citrate, dipotassium EDTA and sodium heparin), and fingerstick whole blood.  The SCoV-2 Detect™ IgG Rapid Test is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. The SCoV-2 Detect™ IgG Rapid Test should not be used to diagnose or exclude acute SARS-CoV-2 infection. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity.

Testing of serum, plasma, and venous whole blood specimens 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 high or moderate complexity tests. Testing of fingerstick whole blood specimens 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 high, moderate or waived complexity tests. Testing of fingerstick whole blood specimens 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 for emergency use by FDA under an EUA for use by authorized laboratories;
• This product has been authorized only for detecting the presence of IgG antibodies to 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.