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.
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 | double-antigen sandwich assay; quantitative | |
| Calibration | Individual 2-point calibration | |
| Traceability | WHO Reference Reagent for Hepatitis E Virus Antibody (NIBSC code: 95/584) | |
| Measuring range | 0.05-25 U/mL; Limit of Detection = 0.025 U/mL | |
| Result interpretation | < 0.15 U/mL = non-reactive for anti-HEV IgG ≥ 0.15 U/mL = reactive for anti-HEV IgG |
|
| 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 | 20 µL | 12 µL |
| Intermediate precision (CV) in positive samples | 2.1-2.7% cobas® e 411 analyzer 1.0-1.3% cobas® e 601 / cobas® e 602 modules |
1.1-1.3% |
| 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 | 99.8% (95% CI 99.6-99.9%); N=8011 | |
| Relative sensitivity | 99.1% (95% CI 98.0-99.7%); N=646 | |
Learn more about Hepatitis E and the Elecsys® Anti-HEV IgG features.
References
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.
