Basic evaluation of HISCL-2000i assay of hepatitis B virus surface antigen

DOI
  • YAMADA Miyuki
    Department of Infection Control, The University of Yamagata Hospital Department of Clinical Laboratory, The University of Yamagata Hospital
  • ABE Tomoyo
    Department of Clinical Laboratory, The University of Yamagata Hospital
  • SATO Naohito
    Department of Clinical Laboratory, The University of Yamagata Hospital
  • SATO Tomoaki
    Department of Clinical Laboratory, The University of Yamagata Hospital Department of Infection Control, The University of Tokyo Hospital
  • MORIKANE Keita
    Department of Infection Control, The University of Yamagata Hospital Department of Clinical Laboratory, The University of Yamagata Hospital

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  • 全自動免疫測定装置HISCL-2000iによるHBs抗原測定の基礎的検討

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Abstract

We compared the hepatitis B virus surface antigen (HBsAg) assay using HISCL-2000i (HISCL) with those using Architect (Arc) and Lumipulse Prest II (Lum). Good results were obtained using the HISCL assay in terms of simultaneous repeatability, daily precision and minimum detection level. Microfibrin contained in the specimen affected the accuracy of the value obtained using the Lum assay, but not those obtained using the HISCL and Arc assays. The correlation of the values obtained using the HISCL and Arc assays was generally consistent. However, the values obtained using the HISCL assay tend to be higher than those obtained using the Lum assay for the specimens with low HBsAg concentrations, whereas those obtained using the HISCL assay tend to be lower for the specimen with high HBsAg concentrations, suggesting the effect of dilution. In the HBsAg mutant detection test, the detection rate was 100% with the HISCL assay, and the Arc assay could detect all 22 HBsAg mutants tested, but the Lum assay could detect all except the mutant of D144-G145R. These results suggest that the HISCL assay is both sensitive and specific, with the capability to detect various types of HBsAg mutant.

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