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Anti-HEV IgM assay is used to perform qualitative detection of IgM antibody to hepatitis E virus in human serum or plasma. Repeatedly reactive result is presumptive evidence of IgM antibodies to HEV in the specimen. A non-reactive result indicates the likely absence of detectable IgM antibodies to HEV. Negative result does not exclude the possibility of exposure to or infection with HEV.