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

SCoV-2 Detect^TM IgG ELISA kit is an in vitro diagnostic test for the qualitative detection of IgG antibodies to SARS-CoV-2 in human serum or plasma (dipotassium EDTA) run manually or using the DYNEX DSX^®  Automated ELISA System.

The test is intended as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity. The SCoV-2 Detect™ IgG ELISA should not be used to diagnose acute SARS‑CoV‑2 infection.

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 (automated method) or high (manual and automated method) complexity tests.

• 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 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.

FAQs:

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• FAQs
• Package Insert (English & Spanish)
• Brochure
• SDS (US & EU)
• FDA Letter of Authorization
• Fact Sheet for Recipients
• Fact Sheet for Health Care Providers