Elecsys® HBsAg II quant

hbsag-ii-assay-com

Consistent and reliable results for patient-oriented decision making

  • Hepatitis B virus is a common, ubiquitous etiologic agent for viral hepatitis
  • It is transmitted percutaneously, sexually and perinatally and affects 350 to 400 million people worldwide.
  • The disease is not always self-limiting - approximately 15 % of acute infections will take a chronic course of various degrees of severity
  • HBV accounts annually for 1 million deaths from cirrhosis, liver failure and hepatocellular carcinoma
  • The ideal end-point of hepatitis B therapy is sustained HBsAg loss with or without seroconversion to anti-HBs
  • This is associated with a complete immune control of the virus and remission of the activity of chronic hepatitis B and an improved long-term outcome
  • Several recent studies suggest monitoring pegylated interferon alpha therapy with HBsAg quantification in addition to HBV DNA quantification
Assay time
18 min
Sample material Serum collected using standard sampling tubes or tubes containing separating gel.
Li-heparin, Na-heparin, EDTA- and citrate-plasma.
Sample volume 50 μL
Measuring range 0.05 IU/mL - 52,000 IU/mL
Intermediate precision cobas e 411 analyzer, Elecsys® 2010 analyzer: 5.6% (3-6610IU/mL)
cobas e 601 / e 602 module, E170: 4.9 - 9.6 % (3-37300 IU/mL)
Dilution
The dilution step is performed by the analyzer (on board dilution; 1:400 on E170/cobas e 601/e 602 and 1:100 on E2010/cobas e 411)
Traceability NIBSC standard (code number: 00/588; WHO Second International Standard for HBsAg
Onboard stability 8 weeks

A powerful tool for therapy monitoring

Optimized management of chronic hepatitis B patients:

  • Via the combination of HBV DNA and HBsAg quantification

Enables a response-guided therapy:

  • For Interferon based treatment (e.g. PEGASYS) of chronic hepatitis B patients

Markers for risk prediction:

  • Of cirrhosis and hepatocellular carcinoma and accurate identification of inactive carriers

Enhanced convenience:

  • Reduces retesting due to broad linear measuring range, onboard dilution and 8 weeks onboard stability

Maximum reliability:

  • Accurate results, eliminating pipetting errors and validated with all genotypes

Optimized for clinical decision making:

  • Linear range reflecting relevant HBsAg titers, excellent precision and traceable to WHO second international standard for HBsAg

Multicenter evaluation of the Elecsys hepatitis B surface antigen quantitative assay:
Zacher, B.J., Moriconi, F., Bowden, S., Hammond, R., Louisirirotchanakul, S., Phisalprapa, P., Tanwandee, T., Wursthorn, K., Brunetto, M.R., Wedemeyer, H., Bonino, F. Clinical and Vaccine Immunology (2011), Nov, 18(11):1943-50

Summary:

  • The Elecsys HBsAg II quant assay reliably quantified HBsAg in routine clinical samples across all major HBV genotypes encountered globally, and at all stages of infection tested, including in sera with high HBsAg levels (up to 873,300 IU/mL).
  • The assay gave exact results over a broad linear range (0.05–52,000 IU/mL) reflecting clinically relevant HBsAg titers.
  • The defined onboard dilution step reduces the need for retesting; more than 70% of the samples gave a final result on first analysis.
  • Onboard dilution reduces the potential for pipetting errors, lowers “hands-on” time and saves costs. The assay showed high precision across the entire measuring range. The Elecsys HBsAg II quant assay is standardized against the WHO Second International Standard for HBsAg.

Conclusion:
The Elecsys® HBsAg II quant assay is highly suitable for the quantification of HBsAg levels in routine clinical samples, providing accurate, standardized results for clinical decision making.

Performance evaluation of new automated hepatitis B viral markers in the clinical laboratory: two quantitative hepatitis B surface antigen assays and an HBV core-related antigen assay:
Hyon-Suk Kim,Yongjung Park, Duck Jin Hong, Saeam Shin, Yonggeun Cho (2012). American Journal of Clinical Pathology, May;137(5), 770-7

Summary:

  • Elecsys showed good precision performance with coefficients of variation between 4.5% and 5.3% and Abbott’s coefficients of variation between 4.6% and 13.4% for pooled serum samples. The Elecsys HBsAg II quant assay was verified to be linear in the range between the HBsAg levels of 0.081 and 12,708.0 IU/mL (linear fit, y = 0.9840x + 1.7730; F = 8,651.20; P < .0001; R2 = 0.9979) The Elecsys HBsAg II quant assay agreed well with the previously developed Architect assay with a high correlation of r = 0.9934 for the 529 specimens

Conclusion:
The Elecsys HBsAg II quant assay showed better precision performance of around 5% CV for the pooled serum samples at 3 levels compared with the Architect HBsAg quant assay. Also it showed very high correlation with the Architect HBsAg assay.