Fact Sheet for Healthcare Providers: Abbott Laboratories, AdviseDx SARS-CoV-2 IgM [open pdf - 289KB]
From the Document: "This Fact Sheet informs you of the significant known and potential risks and benefits of the emergency use of the AdviseDx SARS-CoV-2 [severe acute respiratory syndrome coronavirus 2] IgM [Immunoglobulin M] assay. You should not interpret the results of this test as an indication or degree of immunity or protection from reinfection. The AdviseDx SARS-CoV-2 IgM assay is authorized for the qualitative detection of IgM antibodies to SARS-CoV-2 in human serum, serum separator tube, and plasma (dipotassium EDTA [Ethylenediaminetetraacetic acid], tripotassium EDTA, lithium heparin, lithium heparin separator tube, sodium heparin)."
U.S. Food and Drug Administration: https://www.fda.gov/