SCoV-2 Detect™ IgG ELISA

The SCoV-2 Detect™ IgG ELISA 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 SCoV-2 Detect™ IgG ELISA 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 or exclude 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.

Results are for the detection of IgG SARS-CoV-2 antibodies. IgG antibodies to SARS-CoV-2 are generally detectable in blood several days after initial infection, although the duration of time antibodies are present post-infection is not well characterized. Individuals may have detectable virus present for several weeks following seroconversion.

Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities.
Negative results do not preclude acute SARS-CoV-2 infection. If acute infection is suspected, direct testing for SARS-CoV-2 is necessary.

False positive results for SCoV-2 Detect™ IgG ELISA may occur due to cross-reactivity from pre-existing antibodies or other possible causes.

• 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.

The SCoV-2 Detect™ IgG ELISA is only for use under the Food and Drug Administration Emergency Use Authorization (EUA).