SCoV-2 Detect™ IgM ELISA
FDA Emergency Use Authorized and CE Marked
The SCoV-2 Detect™ IgM ELISA is an in vitro diagnostic test for the qualitative detection of IgM antibodies to SARS-CoV-2 in human serum and plasma (dipotassium EDTA).
The 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. 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™ IgM 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 high complexity tests.
- This test has not been FDA cleared or approved but has been authorized by FDA under an EUA for use by authorized laboratories;
- This test has been authorized only for detecting IgM antibodies to SARS-CoV-2, not for any other viruses or pathogens; and
- The emergency use of this test 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.
Click Downloads Below For:
- Package Insert (English & Spanish)
- SDS (US & EU)
- FDA Letter of Authorization (Updated/Reissued March 25, 2021)
- Fact Sheet for Recipients
- Fact Sheet for Health Care Providers