Elecsys® HBsAg II quant II

Immunoassay for the quantitative determination of hepatitis B surface antigen (HBsAg)

Elecsys HBsAg II quant II

Immunoassay for the quantitative determination of hepatitis B surface antigen (HBsAg)

Hepatitis B is a potentially life threatening liver infection caused by the hepatitis B virus (HBV). It is transmitted through contact with the 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 90 % of the cases.1

An estimated 257 million people are living with HBV infection. In 2015, hepatitis B resulted in 887,000 deaths, mostly from complications (including cirrhosis and hepatocellular carcinoma).1 Sustained HBsAg loss with or without seroconversion to anti-HBs is associated with complete immune control of the virus, remission of the activity of chronic hepatitis B (CHB) and an improved long-term outcome.2-4 

Seroclearance of HBsAg is now considered the goal for functional cure of CHB.5 As a result, quantification of HBsAg levels is now routinely used to monitor natural disease progression and to predict the response to antiviral treatment in CHB patients receiving peginterferon alfa-2a and nucleos(t)ide analogues, as well as during clinical studies of new HBV therapeutics.6-7

Elecsys® HBsAg II quant II

Elecsys® HBsAg II quant II

  • Systems

    cobas e 411 analyser, cobas e 601 / cobas e 602 modules, cobas e 801 module

  • Testing Time

    18 minutes

  • Test principle

    Sandwich assay.

  • Calibration

    2-point

  • Interpretation

    The analyser automatically calculates the analyte concentration (IU/mL) based on the measurement of Cal1 and Cal2. In case of a manual pre-dilution, the dilution factor needs to be accounted for manual calculation of the final result.

     

  • Sample material

    Serum collected using standard sampling tubes or tubes containing separating gel. Li‑heparin, Na‑heparin, K2‑EDTA, or Na‑citrate plasma.

  • Sample volume

    50 μL cobas e 411 analyser, cobas e 601 / cobas e 602 modules
    30 μL cobas e 801 module

  • Onboard stability

    8 weeks cobas e 411 analyser, cobas e 601 / cobas e 602 modules
    16 weeks cobas e 801 module

  • Intermediate precision in positive samples

    cobas e 411 analyser: CV 2.9 – 5.3 %
    cobas e 601 / cobas e 602 modules CV 2.0 – 5.3 %
    cobas e 801 module CV 2.1 – 2.9 %

  • Measuring range for diluted samples*

    cobas e 411 analyser: 5 – 13,000 IU/mL
    cobas e 601 / cobas e 602 modules: 20 – 52,000 IU/mL
    cobas e 801 module: 45 – 117,000 IU/mL for 900-fold diluted samples 1,350 – 3,510,000 IU/mL for 27,000-fold diluted   samples

     

  • cobas e flow

    cobas e 411 analyser: N/A
    cobas e 601 / cobas e 602 modules: N/A
    cobas e 801 module: Automatic rerun with or without dilution, for convenient use of extended measuring

     

* Measuring range for undiluted samples: 0.05 – 130 IU/mL for all platforms

 

References

 

  1. WHO. Hepatitis B. Fact sheet N°204. Available at: http://www.who.int/mediacentre/factsheets/fs204/en, accessed November 2017.
  2. Lampertico, P. et al. (2017). EASL 2017 Clinical Practice Guidelines on the management of hepatitis B virus infection. J. Hepatol. 67, 370-398.
  3. Sarin, S.K. et al. (2016). Asian-Pacific clinical practice guidelines on the management of hepatitis B: a 2015 update. Hepatol. Int. 10, 1-98.
  4. Terrault, N.A. et al. (2016). AASLD guidelines for treatment of chronic hepatitis B. Hepatology 63, 261-283.
  5. Lok, A.S. et al. (2017). Hepatitis B cure: From discovery to regulatory approval. J. Hepatol. 67, 847-861.
  6. Cornberg, M., et al. (2017). The role of quantitative hepatitis B surface antigen revisited. J. Hepatol. 66, 398-411.
  7. National Institute for Health and Care Excellence. (2013). Hepatitis B (chronic): diagnosis and management of chronic hepatitis B in children, young people and adults. Available from: http://www.nice.org.uk/nicemedia/live/14191/64234/64234.pdf, Accessed November 2017.