title: Multicenter evaluation of the Elecsys hepatitis B surface antigen quantitative assay.
abstract: The Elecsys hepatitis B surface antigen (HBsAg) II quantitative assay is a new quantitative electrochemiluminescence immunoassay which uses onboard dilution and a simple algorithm to determine HBsAg levels expressed in international units (IU)/ml (standardized against the World Health Organization [WHO] Second International Standard). This study evaluated its performance using routine serum samples from a wide range of HBsAg carriers and patients with chronic hepatitis B (CHB). HBsAg levels were measured in serum samples collected independently by five centers in Europe, Australia, and Asia. Serial dilution analyses were performed to assess the recommended dilution algorithm and determine the assay range free of hook effect. Assay precision was also established. Following assessment of serial dilutions (1:100 to 1:1,000,000) of the 611 samples analyzed, 70.0% and 85.6% of samples tested with analyzers incorporating 1:100 (Elecsys 2010 and cobas e 411) and 1:400 (Modular Analytics E170) onboard dilution, respectively, fell within the linear range of the assay, providing a final result on the first test. No high-dose hook effect was seen up to the maximum HBsAg serum level tested (870,000 IU/ml) using the dilution algorithm. HBsAg levels were reliably determined across all hepatitis B virus (HBV) genotypes, phases of HBV infection, and stages of disease tested. Precision was high across all analyzers (% coefficient of variation [CV], 1.4 to 9.6; HBsAg concentrations, 0.1 to 37,300 IU/ml). The Elecsys HBsAg II quantitative assay accurately and reliably quantifies HBsAg in routine clinical samples. Onboard dilution minimizes retesting and reduces the potential for error.
authors: Medizinische Hochschule Hannover, Klinik für Gastroenterologie, Hepatologie und Endokrinologie, Carl-Neuberg-Str. 1, 30625 Hannover, Germany.
authors: B J
authors: BJ
authors: Zacher
authors: F
authors: F
authors: Moriconi
authors: S
authors: S
authors: Bowden
authors: R
authors: R
authors: Hammond
authors: S
authors: S
authors: Louisirirotchanakul
authors: P
authors: P
authors: Phisalprapa
authors: T
authors: T
authors: Tanwandee
authors: K
authors: K
authors: Wursthorn
authors: M R
authors: MR
authors: Brunetto
authors: H
authors: H
authors: Wedemeyer
authors: F
authors: F
authors: Bonino
mesh_terms: D001208:Asia; D001315:Australia; D019411:Clinical Laboratory Techniques / Q000379:methods*; D005060:Europe; D006509:Hepatitis B / Q000175:diagnosis*; D006514:Hepatitis B Surface Antigens / Q000097:blood*; D006801:Humans; D007118:Immunoassay / Q000379:methods; D011933:Reagent Kits, Diagnostic
chemical_list: D006514:Hepatitis B Surface Antigens; D011933:Reagent Kits, Diagnostic