Elecsys® Anti-HEV IgM

IVD For in vitro diagnostic use.
Elecsys<sup>®</sup> Anti-HEV IgM
Immunoassay for the qualitative detection of IgM antibodies to the hepatitis E virus (HEV) in human serum and plasma

Elecsys Anti-HEV IgM is an immunoassay for the in vitro qualitative detection of IgM antibodies to the hepatitis E virus (HEV) in human serum and plasma. The Elecsys Anti‑HEV IgM assay is used as an aid to detect an acute or recently acquired HEV infection.

The Elecsys® Anti-HEV IgM assay uses recombinant proteins based on structural domains of HEV ORF2 (genotype 1 and 3) as antigens in a μ-capture assay format for the qualitative detection of IgM antibodies to HEV. Qualitative measurement of IgM antibodies to HEV is intended as an aid, in conjunction with other laboratory results and clinical information, in the diagnosis of acute HEV infection (e.g., by detecting anti-HEV IgM antibodies during acute infection, in combination with rising titers of IgG antibodies to HEV or HEV RNA), as part of the differential diagnosis of acute hepatitis to enable timely initiation of medical interventions. Testing for HEV infection, including anti-HEV IgM antibodies, is also indicated in pregnant women.

About HEV and hepatitis E1-8

Hepatitis E Virus (HEV) is recognized as the fifth major cause of human viral hepatitis and is likely the leading cause of acute hepatitis and jaundice worldwide. As per the World Health Organization, around 20 million people globally are infected each year, resulting in roughly 3.3 million symptomatic cases of Hepatitis E and about 44,000 fatalities. There are four main genotypes of HEV that can infect humans: Genotypes 1 and 2 are common in developing countries and are transmitted fecal-orally by contaminated water and food. On the other hand, Genotypes 3 and 4 are common in developed countries and can occasionally transmit to humans zoonotically through close contact with infected animals or consumption of contaminated animal products. While most individuals with HEV infection do not exhibit symptoms and typically experience spontaneous viral clearance without treatment, HEV infection can lead to severe hepatitis with liver failure and death in patients with certain risk factors (e.g. underlying chronic liver disease, pregnancy). In immunocompromised individuals, the infection can become chronic, leading to cirrhosis. Both acute and chronic HEV infections can manifest extrahepatically.

Elecsys Anti-HEV IgM assay characteristics9

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Elecsys Anti-HEV IgM assay characteristics9

Systems cobas® e 411 analyzer,
cobas® e 601 / cobas® e 602 modules
cobas® e 402 / cobas® e 801 analytical units
Testing time 18 minutes
Test principle μ-capture assay with 1:20 automatic sample pre-dilution; qualitative
Calibration Individual 2-point calibration
Traceability Roche reference standard
Result interpretation

COI < 1.0 = non-reactive for anti-HEV IgM
COI ≥ 1.0 = reactive for anti-HEV IgM

Specimen types Serum collected using standard sampling tubes or tubes containing separating gel.
Li-heparin, Na-heparin, K2-EDTA, K3-EDTA and Na-citrate plasma. Plasma tubes containing separating gel can be used.
Sample volume 10 µL 6 µL
Intermediate precision (CV) in positive samples

cobas® e 411: 2.4-3.0%
cobas® e 601/602: 5.9-6.8%

Analytical specificity No cross-reactions with samples containing antibodies against HAV, HBV, HCV, HIV, EBV, HSV, Rubella or CMV, samples from autoimmune diseases (AMA and ANA)
Relative specificity 99.4% (95% CI 99.2-99.6%); N=8011
Relative sensitivity 98.7% (95% CI 97.3-99.5%); N=707
COI: cutoff index; CV: coefficient of variation; CI: confidence interval
Course of HEV infection and diagnostic markers2,10,11
Elecsys HEV IgG
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Download the Factsheet

Learn more about Hepatitis E and the Elecsys® Anti-HEV IgM features.

Elecsys® Anti-HEV IgM factsheet


  1. Rein OB, et al. The global burden of hepatitis E virus genotypes 1 and 2 in 2005. Hepatology. 2012;55:988-97.
  2. Webb GW, Dalton HR. Hepatitis E: an underestimated emerging threat. Ther Adv Infect Dis.2019;6:1-18.
  3. Peron JM, et al. The pressing need for a global HEV vaccine. J Hepatol. 2023;79:876-880.
  4. World Health Organization. Hepatitis E [Internet; updated 2023 Jul 23; cited 2023 Sep 18]. Available from: https://www.who.int/news-room/fact-sheets/detail/hepatitis-e.
  5. Debing Y, et al. Update on hepatitis E virology: Implications for clinical practice. J Hepatol. 2016;65:200-212.
  6. Kamar N, et al. Hepatitis E. Lancet. 201 2:379:2477-2488
  7. Goel A. Aggarwal R. Hepatitis E: Epidemiology, Clinical Course, Prevention, and Treatment. Gastroenterol Clin North Am. 2020;49:315-330.
  8. Fousekis FS, et al. Extrahepatic manifestations of hepatitis E virus: An overview. Clin Mol Hepatol. 2020;26:16-23
  9. Elecsys® Anti-HEV IgM. Material Numbers 09056246190 and 09056254190, Method Sheet 2023-09, V1.0.
  10. Aggarwal R, Goel A. Natural History, Clinical Manifestations, and Pathogenesis of Hepatitis E Virus Genotype 1 and 2 Infections. Cold Spring Harb Perspect Med. 2019;9:a032136.
  11. Lhomme S, et al. Screening, diagnosis and risks associated with Hepatitis E virus infection. Expert Rev Anti Infect Ther. 2019;17:403-418.


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