title: Detection of Hepatitis B Virus Large Surface Protein Using a Time-Resolved Immunofluorometric Assay.
abstract: BACKGROUND
  To establish a novel method based on time-resolved immunofluorometric assay (TR-IFMA) with higher sensitivity and a broader detection range for detecting serum hepatitis B virus large surface protein (L protein).
  
  
  METHODS
  The precision, sensitivity, specificity, coefficient of recovery, and stability of the assay were evaluated and comparison with the classical enzyme-linked immunosorbent assay (ELISA) was also executed.
  
  
  RESULTS
  The precision, specificity, and sensitivity of the TR-IFMA were clearly better than ELISA. Particularly, the sensitivity was 0.1 ng/ml; moreover, the specificity was 100%, 96%, 92.5%, 96.9%, 97.8%, and 100% in the sera of healthy blood donors, systemic lupus erythematosus (SLE) patients, rheumatoid arthritis (RA) patients, hepatitis C virus (HCV) patients, cytomegalovirus (CMV) infection patients, and pregnant patients, respectively. Meanwhile, we observed that the established TR-IFMA kit has a wider acceptable linear range of 0.63-10,367 ng/ml rather than the regular commercial ELISA kit having range of only 10.12-1095.9 ng/ml. Subsequently, correlation coefficient between the TR-IFMA and ELISA was 0.8009. The intra- and interassay precision rates were less than 5% for three different concentrations. The average recovery rate for L protein was 101.17%. In sum, the established assay kit performed better in terms of stability than the commercial ELISA kit.
  
  
  CONCLUSIONS
  The TR-IFMA that we developed for L protein presented a higher sensitivity and wider detecting range than regular commercial ELISA. Therefore, this TR-IFMA has promising value both in the screening of HBV and monitoring of antiviral therapy.
authors.affiliation: Department of Laboratory Medicine, The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, China.|Department of Laboratory Medicine, Affiliated Wuxi people's Hospital of Nanjing Medical University, Wuxi, China.
authors.forename: Zhigang
authors.initials: Z
authors.lastname: Hu
authors.affiliation: Department of Laboratory Medicine, Affiliated Wuxi people's Hospital of Nanjing Medical University, Wuxi, China.
authors.forename: Mei
authors.initials: M
authors.lastname: Li
authors.affiliation: Department of Laboratory Medicine, Affiliated Wuxi people's Hospital of Nanjing Medical University, Wuxi, China.
authors.forename: Jie
authors.initials: J
authors.lastname: Liu
authors.affiliation: Department of Laboratory Medicine, Affiliated Wuxi people's Hospital of Nanjing Medical University, Wuxi, China.
authors.forename: Lei
authors.initials: L
authors.lastname: Yu
authors.affiliation: Department of Laboratory Medicine, Affiliated Wuxi people's Hospital of Nanjing Medical University, Wuxi, China.
authors.forename: Yifeng
authors.initials: Y
authors.lastname: Xue
authors.affiliation: Department of Laboratory Medicine, The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, China.
authors.forename: Yu
authors.initials: Y
authors.lastname: Chen
mesh_terms: D001172:Arthritis, Rheumatoid / Q000097:blood / Q000175:diagnosis*; D015415:Biomarkers / Q000097:blood; D016022:Case-Control Studies; D003587:Cytomegalovirus; D003586:Cytomegalovirus Infections / Q000097:blood / Q000175:diagnosis* / Q000382:microbiology; D004797:Enzyme-Linked Immunosorbent Assay; D005260:Female; D015200:Fluoroimmunoassay / Q000379:methods*; D005500:Follow-Up Studies; D016174:Hepacivirus; D006509:Hepatitis B / Q000097:blood / Q000175:diagnosis* / Q000821:virology; D006515:Hepatitis B virus; D006526:Hepatitis C / Q000097:blood / Q000175:diagnosis* / Q000821:virology; D006801:Humans; D008180:Lupus Erythematosus, Systemic / Q000097:blood / Q000175:diagnosis*; D011247:Pregnancy; D011379:Prognosis; D012372:ROC Curve; D014759:Viral Envelope Proteins / Q000097:blood*
chemical_list: D015415:Biomarkers; C096362:L protein, hepatitis B virus; D014759:Viral Envelope Proteins
keywords: enzyme-linked immunosorbent assay; hepatitis B virus large surface protein; time-resolved immunofluorometric