ABSTRACT
Objective To establish detection limit and clinical reportable range for detection of anti-HBs by chemiluminescence method and evaluate by clinical application.Methods Referring to the Clinical and Laboratory Standards Institute (CLSI) relevant documents,the programme of blank limit (LoB),detection limit (LoD),quantitative detection limit (LoQ),analytical range of measurement (AMR),clinical reportable range (CRR) for detection of anti-HBs by chemiluminescence method,were designed and measured.The established clinical reportable range and maximum dilution were used to predict the recovery stage of acute hepatitis B patients and to evaluate the effectiveness of different vaccines.Results LoB,LoD,LoQ,AMR and CRR for detection of anti-HBs by chemiluminescence method were 0.87,1.89,3.0,0～970.50 and 3.0 ～48 525 mIU/ml respectively,and the maximum dilution was 1 ∶ 50.The patient with acute hepatitis B showed elevated anti-HBs at fourth weeks after treatment (CRR).The anti-HBs mean was the highest in the B vaccine of the three vaccines.Conclusion The establishment of detection limit and clinical reportable range for detection of anti-HBs by chemiluminescence method was better meet the requirements of clinical laboratories,provide reliable results for clinical laboratories.