Elecsys® HBsAg II

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 - in adults, approximately 15 % of acute infections will follow a chronic course of varying degrees of severity and the rate of chronification is higher in early childhood
  • Long-term chronic infection accounts annually for 1 million deaths from cirrhosis, liver failure and hepatocellular carcinoma
  • Hepatitis B surface antigen (HBsAg) is a polypeptide component of the external envelope of HBV, presenting various immunogenic determinants
  • After infection, HBsAg is the first immunological marker detectable in serum and is usually present weeks before the onset of clinical symptoms and the appearance of other biochemical markers
Assay time
18 min
Sample material Serum, Li-heparin, EDTA, citrate plasma
Sample volume 50 μL
Traceability NIBSC 00/588; WHO 2nd International Standard for HBsAg, subtype adw2, genotype A; UI/mL
Clinical sensitivity 99.9 % (n = 1025 confirmed HBsAg positive samples);
1 sample negative in all HBsAg assays tested
Clinical specificity
99.98 % (n = 6360 blood donors)
99.88 % (n = 3593 hospitalized patients)
Interpretation coi < 0.9 not reactive
0.9 ≤ coi < 1.0 borderline
coi ≥ 1.0 reactive
Mutant recognition
112 / 115 tested mutants (native and recombinant) were correctly
recognized; 3 samples negative in all HBsAg assays tested

Reliable detection of HBV infection

  • High specificity in clinical routine and blood donors means less retesting
  • High seroconversion sensitivity for early detection of infection
  • High clinical sensitivity and reliable detection of relevant HBV mutants and genotypes
  • Short total assay time

Multicenter study of a new fully automated HBsAg screening assay with enhanced sensitivity for the detection of HBV mutants:
Mühlbacher A., Weber B., Bürgisser P., Eiras A., Cabrera J., Louisirirotchanakul S., Tiller FW., Kim H.S., v. Helden J., Bossi V., Echevarria JM. (2008, Epub 2007 Sep 21). Med Microbiol Immunol. Mar;197(1), 55-64.

Comparison of the technical and clinical performance of the Elecsys HBsAg II assay with the Architect, AxSym, and Advia Centaur HBsAg screening assays:
Louisirirotchanakul, S., Khupulsup, K., Akraekthalin, S., Chan, K.P., Saw, S., Aw, T.C., Cho, D.H., Shin, M.G., Lim, J. J Med Virol. (2010) Mar 24;82(5):755-762