title: [Clinical evaluation of a newly developed high-sensitive detection of hepatitis B virus surface antigen by a semi-automated immune complex transfer chemiluminescent enzyme immunoassay].
abstract: OBJECTIVE
  A highly sensitive semi-automated immune complex transfer chemiluminescence enzyme immunoassay (ICT-CLEIA) for the detection of hepatitis B surface antigen (HBsAg) was recently developed. Our aim is to investigate clinical significance of ICT-CLEIA in patients with HBV.
  
  
  METHODS
  Of 829 HB carriers in our hospital and 167 commercial panels, performance of ICT-CLEIA(detection range 0.0005-2.5 IU/mL) was compared with two quantitative HBsAg detection systems (Architect HBsAg QT assay [0.05-250 IU/mL] and HISCL HBsAg assay [0.03-2500 IU/mL]) and COBAS TaqMan HBV-DNA assay (CTM, 2.1 Log copies/ml) using serum samples from patients or panels.
  
  
  RESULTS
  The ICT-CLEIA had good accuracy and reproducibility. The sensitivity of wild type and HBsAg escape mutants (I126S, D144A, G145R) by ICT-CLEIA was 2- -5 to 2- -6 times higher than that of Architect HBsAg QT. For clinical practice, ICT-CLEIA assay could detect HBsAg even in the presence of anti-HBs during window periods in acute hepatitis B panel. HBsAg has been detectable for around 9 years in a patient with HBsAg clearance by Architect. In a patient with HBV reactivation after bone marrow transplantation followed by systematic chemotherapy, HBsAg by ICT-CLEIA was detectable at the same time point when HBV-DNA was detected by PCR. In conclusion, the ICT-CLEIA assay permits not only an earlier detection of acute hepatitis B infection but also may be useful for monitoring hepatitis B patients.
authors.forename: Kumiko
authors.initials: K
authors.lastname: Ohne
authors.forename: Satomi
authors.initials: S
authors.lastname: Kani
authors.forename: Minoru
authors.initials: M
authors.lastname: Ohashi
authors.forename: Noboru
authors.initials: N
authors.lastname: Shinkai
authors.forename: Takako
authors.initials: T
authors.lastname: Inoue
authors.forename: Yukio
authors.initials: Y
authors.lastname: Wakimoto
authors.affiliation: Department of Virology and Liver Unit, Central Clinical Laboratory, Nagoya City University Hospital, Nagoya 467-8601, Japan.
authors.forename: Yasuhito
authors.initials: Y
authors.lastname: Tanaka
mesh_terms: D000936:Antigen-Antibody Complex / Q000235:genetics / Q000276:immunology*; D057205:Automation, Laboratory; D006510:Hepatitis B Antibodies / Q000276:immunology*; D006514:Hepatitis B Surface Antigens / Q000032:analysis* / Q000276:immunology; D006515:Hepatitis B virus / Q000235:genetics / Q000276:immunology*; D006801:Humans; D007124:Immunoenzyme Techniques / Q000379:methods*; D008163:Luminescent Measurements / Q000379:methods*; D015203:Reproducibility of Results
chemical_list: D000936:Antigen-Antibody Complex; D006510:Hepatitis B Antibodies; D006514:Hepatitis B Surface Antigens