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.
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.
| 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 |
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| 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. |
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| Sample volume | 10 µL | 6 µL |
| Intermediate precision (CV) in positive samples | cobas® e 411: 2.4-3.0% |
5.1-6.1% |
| 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 |
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Learn more about Hepatitis E and the Elecsys® Anti-HEV IgM features.
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