| ?Objective? Hepatitis B virus(HBV) infection is pop?lar all over the world and the prevalence is remarkably high in China. Hepatitis B surface antigen(HBs Ag) is a predominant serum marker for the diagnosis of hepatitis B virus(HBV) infection. Some articles focused on the performance comparison of different detection system within the same detection principle. There were few reports about systematic evaluation of different methods based on different principles. Comparison of different methods in different principle within large sample range is conducive to clarify the diagnostic values of different methods and reg?late the laboratory pathway.?Method? 250 HBs Ag Sera were collected from Aug 1st, 2015 to Sep 30 th, 2015 in the First Affiliated Hospital of Fujian Medical University. Chemiluminescent microparticle immunoassay(CMIA), electro-chemiluminescent immunoassay(ECLIA), enzyme-linked immunosorbent assay(ELISA) and golden immunochromatographic assay(GICA) were used for detection. Imprecisions were evaluated according to the EP12-A2 and EP15-A2 documents, descriptive statistics and correlation analysis were used to calc?late the precisions of the res?lts and consistency and relevance between the res?lts of the different detection methods. A total of 266,803 samples were collected from Jan 1st, 2009 to Dec 31 st, 2015 in First Affiliated Hospital of Fujian Medical University, including the outpatients, inpatients and people from Medical Examination Center, and their HBs Ag level were detected. Diagnostic values for 266,803 patients of these four methods were assessed according to the evaluation res?lts of their performance.?Res?lt? The positive rate of HBs Ag was 25.16%(67128/266803) and the HBs Ag level in HBs Ag positive patients mainly ranged at 130.01~52000 IU/ml(71.43% of the positive samples and 17.97% of total). The C50 of HBs Ag by CMIA, ECLIA, ELISA and GICA was 0.064, 0.085, 0.17 and 10.00 IU/ml respectively, and the interval of C5-C95 was showed as: ECLIA<CMIA< ELISA <GICA.When the concentration of HBs Ag was fixed in 0.5 IU/ml, the imprecision of CMIA, ECLIA and ELISA was 2.34%, 1.51% and 14.04% respectively. The consistency between CMIA and ECLIA was good in 250 samples, there was no statistical difference(P=0.44); statistical difference was existed between ECLIA and ELISA, CMIA and ELISA, GICA and other three methods, respectively. The consistency of the four methods was good when high HBs Ag level(?12.50 IU/ml) and HBs Ag negative(<0.05 IU/ml) samples were detected by CMIA. There was a high correlation of the quantitative res?lts between ECLIA and CMIA(R2= 0.978). The correlation between ELISA and CMIA was good(R2= 0.928) only when the concentration of HBs Ag was less than 8.0 IU/ml; when the concentration range of HBs Ag extended to 40,561 IU/ml, correlation got poor between them(R2= 0.099). When qualitative detection was conducted to 266,803 samples by the four methods, the consistency of CMIA and ECLIA was good,there was no statistical significance;however, the positive and negative coincidence rates was poor respectively between ECLIA and ELISA, CMIA and ELISA, GICA and other three methods, P values were less than 0.05, there was significant differences; Compared to CMIA, the false negative rate of ECLIA, ELISA and GICA was 0.86%?2.88% and 11.68%, respectively.?Conclusion? GICA was suitable for the preliminary screening of HBs Ag positive individuals and ELISA can be applied to the qualitative detection of HBs Ag. Both CMIA and ECLIA were suitable for the quantitative determination. Reasonable and economic methods can be adopted by different laboratories according to different conditions and requirement of patients in order to establish suitable laboratory pathway. |
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