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 SCoV-2 Detect™ IgM ELISA 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.
Results are for the detection of IgM SARS-CoV-2 antibodies. IgM 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.
Samples should only be tested from individuals that are 7 days to 64 days post symptom onset. SARS-CoV-2 antibody negative samples collected 7 days or more post symptom onset should be reflexed to a test that detects and reports SARS-CoV-2 IgG.
The sensitivity of SCoV-2 Detect™ IgM ELISA early after infection is unknown. 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™ IgM ELISA may occur due to cross-reactivity from pre-existing antibodies or other possible causes.
The SCoV-2 Detect™ IgM ELISA is only for use under the Food and Drug Administration Emergency Use Authorization (EUA).
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.