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Elecsys® Anti-HEV IgM immunoassay

Immunoassay for the quantitative determination of IgG antibodies to the hepatitis E virus (HEV) in human serum and plasma

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Roche Diagnostics Schweiz AG

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Elecsys Anti-HEV IgG is an immunoassay for the in vitro quantitative determination of IgG antibodies to the hepatitis E virus (HEV) in human serum and plasma. The Elecsys Anti‑HEV IgG assay is used as an aid to detect a recent or past HEV infection.

The Elecsys® Anti-HEV IgG assay uses recombinant proteins based on structural domains of HEV ORF2 (genotype 1 and 3) as antigens in a double-antigen sandwich assay format for the quantitative determination of IgG antibodies to HEV. The quantitative assay result is also qualitatively interpreted for the detection of anti-HEV IgG. Measurement of anti-HEV IgG is intended as an aid, in conjunction with other laboratory results and clinical information, in the diagnosis of acute HEV infection in combination with detection of anti-HEV IgM or HEV RNA, as part of the differential diagnosis of acute hepatitis to enable timely initiation of medical interventions, in assessing the immune status to HEV, in estimating the risk of HEV reinfection, or in detecting past HEV infections in seroepidemiological studies.

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