title: Highly sensitive detection of hepatitis B virus surface antigen by use of a semiautomated immune complex transfer chemiluminescence enzyme immunoassay.
abstract: The performance of hepatitis B surface antigen (HBsAg) screening assays is continuously improved to reduce the risk of transfusion-associated hepatitis B. In this study, a semiautomated immune complex transfer chemiluminescence enzyme immunoassay (ICT-CLEIA) for the detection of HBsAg, which is as sensitive as hepatitis B virus (HBV) DNA PCR, was developed; the ICT-CLEIA assay performance was compared with the performance of the Architect HBsAg QT assay and HBV DNA PCR. The specificities in the initial assay and after retesting were 99.50% (1,988/1,998 samples) and 99.95% (1,997/1,998 samples), respectively. The analytical detection limit was determined to be 0.2 mIU/ml using the 2nd International WHO HBsAg standard, and the cutoff value (0.5 mIU/ml) of the ICT-CLEIA assay was 8.0 standard deviations (SD) above the mean of the HBsAg-negative specimens. The ICT-CLEIA assay could detect HBsAg even in the presence of anti-HBs antibodies and demonstrated a 23.6-day-shorter window period using commercially available HBsAg seroconversion panels than the Architect HBsAg QT assay. Furthermore, the monitoring of the viral kinetics by the ICT-CLEIA assay and the HBV DNA PCR produced very similarly shaped curves during both the HBsAg seroconversion and reverse seroconversion periods. Therefore, the ICT-CLEIA assay may be useful not only for an earlier detection of HBV reactivation but also for the monitoring of hepatitis B patients.
authors: Elemental Technology Development Department 1, Technology Development Division, Sysmex Corporation, Kobe, Japan. Takeda.Kazuhiko@sysmex.co.jp
authors: Kazuhiko
authors: K
authors: Takeda
authors: Mari
authors: M
authors: Maruki
authors: Takahiro
authors: T
authors: Yamagaito
authors: Machiko
authors: M
authors: Muramatsu
authors: Yasuhiro
authors: Y
authors: Sakai
authors: Hiroaki
authors: H
authors: Tobimatsu
authors: Hironori
authors: H
authors: Kobayashi
authors: Yoshiteru
authors: Y
authors: Mizuno
authors: Yukio
authors: Y
authors: Hamaguchi
mesh_terms: D000936:Antigen-Antibody Complex / Q000276:immunology; D019411:Clinical Laboratory Techniques / Q000379:methods*; D006509:Hepatitis B / Q000175:diagnosis*; D006514:Hepatitis B Surface Antigens / Q000097:blood*; D006801:Humans; D007124:Immunoenzyme Techniques / Q000379:methods*; D049449:Luminescence; D012680:Sensitivity and Specificity
chemical_list: D000936:Antigen-Antibody Complex; D006514:Hepatitis B Surface Antigens
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