title: [Evaluation and application of a newly developed highly sensitive HBsAg chemiluminescent enzyme immunoassay for chronic hepatitis B patients].
abstract: OBJECTIVE
  A high sensitive chemiluminescent enzyme immunoassay (CLEIA) was developed for quantitative hepatitis B surface antigen (HBsAg) detection by a combination of monoclonal antibodies, each one for a specific epitope of HBsAg, and by improving the conjugation technique (Matsubara, et al. Transfusion 2009). We modified and automated Matsubara's techniques. Our aim is to evaluate the fundamental performance of our assay (prototype) and to investigate the clinical significance of prototype in patients with hepatitis B virus (HBV) infection.
  
  
  METHODS
  We used 226 HBsAg-negative samples and 59 HBsAg-positive samples for evaluation of prototype's accuracy, reproducibility, specificity and sensitivity. We examine correlation between the prototype assay and commercial quantitative HBsAg detection assay (the Abbott ARCHITECT). Performance of prototype was compared with the Abbott ARCHITECT in one chronic hepatitis B patient and one patient with HBsAg seroconversion sequentially.
  
  
  RESULTS
  The prototype assay had good accuracy, reproducibility, specificity and sensitivity. There is positive correlation between the prototype and the Abbott ARCHITECT. The sensitivity of the prototype (5 mIU/mL) was approximately 10 fold higher than the Abbott ARCHITECT (50 mIU/ml). The prototype could detect HBsAg at the HBsAg-negative point by Abbott ARCHITECT in these patients.
  
  
  CONCLUSIONS
  Automatic highly sensitive HBsAg CLEIA prototype is convenient and precise assay for HBV monitoring.
authors.affiliation: Department of Virology, Nagoya City University Graduate School of Medical Sciences, Nagoya 467-8601, Japan.
authors.forename: Noboru
authors.initials: N
authors.lastname: Shinkai
authors.forename: Yasuhito
authors.initials: Y
authors.lastname: Tanaka
authors.forename: Kentaro
authors.initials: K
authors.lastname: Matsuura
authors.forename: Satomi
authors.initials: S
authors.lastname: Kani
authors.forename: Hatsue
authors.initials: H
authors.lastname: Naganuma
authors.forename: Masashi
authors.initials: M
authors.lastname: Mizokami
mesh_terms: D015415:Biomarkers / Q000097:blood; D006509:Hepatitis B / Q000175:diagnosis*; D006514:Hepatitis B Surface Antigens / Q000097:blood*; D006801:Humans; D007124:Immunoenzyme Techniques / Q000379:methods*; D008163:Luminescent Measurements / Q000379:methods*; D008297:Male; D008875:Middle Aged; D008991:Monitoring, Physiologic / Q000379:methods*; D012680:Sensitivity and Specificity
chemical_list: D015415:Biomarkers; D006514:Hepatitis B Surface Antigens