Elecsys® HBeAg quant

IVD For in vitro diagnostic use.
Elecsys<sup>®</sup> HBeAg quant
Elecsys® HBeAg quant

Immunoassay for the in vitro qualitative and quantitative determination of hepatitis B e antigen (HBeAg) in human serum and plasma. The assay can be used as an aid for the diagnosis and monitoring of patients with hepatitis B viral infection.

Hepatitis B is a potentially life threatening liver infection caused by the hepatitis B virus (HBV). It is transmitted through contact with blood or other body fluids of an infected person.1 The disease is not always self limiting: in adults approx. 5 % of acute infections will follow a chronic course of varying degrees of severity; infants will develop chronic hepatitis B in up to 95 % of the cases.1

Approximately 300 million people are estimated to be living with HBV Infection. In 2019, hepatitis B resulted in an estimated 820 000 deaths, mostly from cirrhosis and hepatocellular carcinoma (primary liver cancer).1

HBeAg is a product of the pre-C/C gene that is found in hepatocytes during proliferation of HBV and is an important diagnostic tool to determine the status of ongoing HBV infections. The detection of HBeAg is generally associated with the presence of large quantities of virus as it is a surrogate of viral replication.2-4 HBeAg can be detected in serum shortly after hepatitis B s antigen (HBsAg) during acute HBV infections and when the infection is self-limited, usually disappears before HBsAg, when alanine aminotransferase (ALT) levels peak, followed by the presence of the corresponding antibody (anti‑HBe).3-5


HBeAg can usually be detected when viral replication is high, both in self-limited infections and in chronic hepatitis B; its presence for more than 10 weeks is indicative of a transition to persistent infection. HBeAg seroconversion to anti‑HBe suggests the end of active viral replication and is therefore associated with clinical resolution (self-limited) or remission (chronic disease), marking a transition from the immune-active phase of the disease to the inactive carrier state.3-6

HBV infections can occur without detectable HBeAg due to infection with HBV variants containing precore stop codon mutants; while the virus can no longer produce HBeAg, disease activity is ongoing and anti‑HBe may be present.3,7,8

HBeAg seroconversion is a marker for treatment response and a goal of antiviral therapy in HBeAg positive patients.7,9 As such, quantitative measurement of HBeAg can provide guidance to physicians regarding cessation of antiviral therapy.10

HBeAg is considered an important indicator for risk of mother-to-child transmission11, where the transmission of HBV from HBeAg positive mothers to newborns plays a significant role.12 Clinical guidelines recommend to screen all pregnant women with HBeAg serving as a surrogate marker for HBV replication when no access to HBV DNA testing is available.13

The Elecsys HBeAg quant test is, therefore, meaningful in association with the anti‑HBe test for monitoring the course of HBV infection and the effect of treatment for chronic hepatitis B.3,4,6,7,13

Elecsys HBeAg quant assay characteristics

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Elecsys HBeAg quant assay characteristics

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 One-step sandwich assay
Calibration 2-point 
Traceability Standardized against the 1st WHO International Standard Hepatitis B virus e antigen (HBeAg), code 129097/12 of the Paul-Ehrlich-Institut, Langen (Germany).
Sample material Serum collected using standard sampling tubes or tubes containing separating gel. 
Li‑heparin, Na‑heparin, K2‑EDTA, K3‑EDTA, ACD, CPD, CP2D, CPDA and Na‑citrate plasma. 
Plasma tubes containing separating gel can be used.
Sample volume 35 µL 21 µL
Reagent Onboard stability 8 weeks 16 weeks
Intermediate precision in positive samples

cobas® e 411: CV 5.2 – 7.4 %
cobas® e 601/602: CV 6.5 – 9.7 %

cobas® e 402/801: CV 5.6 – 7.5 %
Limit of Blank 0.05 IU/mL
Limit of Detection 0.10 IU/mL
Limit of Quantitation 0.20 IU/mL
Measuring range Linear:
0.10 IU/mL - 120 IU/mL
Extended measuring range 1:20 dilution: 2400 IU/mL 1:30 dilution: 3600 IU/mL
Result interpretation < 0.23 IU/mL = non-reactive (negative for HBeAg) 
≥ 0.23 IU/mL = reactive (positive for HBeAg)
Relative sensitivity 100 % (310 patients with acute or persistent HBV infection)
Relative specificity 100 % (routine (n = 1001), blood donors (n = 1000), hospitalized patients n = 300),
dialysis (n = 100) and pregnant women (n = 100)) 
Analytical specificity No cross-reactions with HAV, HCV, HEV, CMV, EBV, HSV, HIV, E. coli, Toxoplasma gondii, Rubella and Treponema pallidum
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Download the Factsheet

Learn more about Hepatitis B serologic profiles and proposed clinical Use Cases.

Elecsys® HBeAg quant factsheet


ElectroChemiLuminescence (ECL)


  1. WHO. [Internet; cited 2023 April] Available from: https://www.who.int/en/news-room/fact-sheets/detail/hepatitis-b .
  2. Schweitzer A,et al. Lancet 2015;386(10003):1546-1555.
  3. Seeger, C., et al. Hepadnaviruses. In: Knipe DM, Howley RM editors. Field’s Virology 5th ed. Lippincott Williams and Wilkins, Philadelphia, USA. 2007;76, 2977-3029.
  4. Liaw YF, Chu CM. Lancet 2009;373:582-592.
  5. Turgeon ML. Immunology & Serology in Laboratory Medicine, 2013 5th ed, Elsevier Health Sciences, Missouri, USA. Chapter 23.
  6. Elgouhari HM, et al. Cleve Clin J Med 2008;75:881-889.
  7. Liaw YF. Hepatol Int 2009;3:425-433.
  8. Negro F. Swiss Med Wkly 2011;141:w13264.
  9. Terrault NA, et al. Hepatology 2018;67(4):1560-1599.
  10. WHO. [Internet; cited 2023 April]. Available from: https://www.who.int/publications/i/item/9789241549981 .
  11. Bleich LM, Swenson ES. J Clin Gastroenterol 2014;48(9):765-772.
  12. Park JS, Pan CQ. Hepatol Int 2017;11(6):476-480.
  13. WHO. [Internet; cited 2023 April]. Available from: https://www.who.int/publications/i/item/978-92-4-000270-8.
  14. 14 Hoofnagle, J.H., et al. Ann Intern Med. 1981;94(6):744-748.
  15. Elecsys® HBeAg quant Method Sheet, material number 09318402190 version 09318402500V1.0 and material number 09318399190 version 09318399500V1.0.
  16. Kao JH. 2008;2(4):553-562.
  17. EASL. J Hepatol. 2017;67(2):370-398.
  18. 18 Wong GL, et al. Clin Infect Dis 2016;62(Suppl 4):S298–S305.
  19. Fletcher GJ, et al. J Clin Lab Anal 2016;30:1146–1149.
  20. Yang HI, et al. N Engl J Med 2002;347:168–174.
  21. Mixson-Hayden T, et al. J Clin Virol 2018;109:22–28.
  22. Terrault NA, et al. Hepatology 2016;63:261–283.
  23. Gao YH, et al. World J Hepatol. 2016;8(34):1511-1520.
  24. Wong GL, et al. Clin Infect Dis 2016;62(Suppl 4):S298–S305.
  25. Fried MW, et al. Hepatology. 2008;47(2):428-4345.
  26. Thompson AJ, et al. Hepatology 2010;51:1933–1944.
  27. Bae, SK et al. Med Sci Monit, 2012; 18(12): CR698-705.


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