国产化学发光免疫试剂检测血清HBsAg的应用评价

Evaluation of Domestic Chemiluminescence Immunoassay Kit as a Potential Application in the Detection of HBsAg

目的考核国产化学发光免疫分析试剂检测血清HBsAg的效果,探讨其在血液筛查和临床检测应用中的可行性。方法采用国产化学发光免疫分析试剂筛查345份HBsAg确认阳性的血清标本,比较其与常用的进口和国产酶联免疫检测试剂盒的漏检率;并采用不同浓度的标准HBsAg血清对国产化学发光免疫分析试剂进行线性分析和精密性试验。结果国产化学发光免疫分析检测试剂的漏检率高于Murex和Organon酶联免疫试剂盒,差异有统计学意义(P<0.01),而与国产英科新创(厦门)科技公司和上海科华生物技术有限公司的HBsAg酶联免疫诊断试剂盒的差异无统计学意义;采用标准血清进行线性分析,标本浓度在(0.5～150)ng/ml范围时与化学发光单位量(RLUs)呈良好的线性正相关;分别对低、中、高浓度标准血清进行板内和板间的重复检测,其反应具有良好的重复稳定性。结论化学发光免疫分析法检测血清HB-sAg具有快速、可定量、反应稳定的特点,可用于血液筛查和临床标本的检测。

Objective To assess the effectiveness of domestic chemiluminescence immunoassay （CLIA） kit in the detection of serum hepatitis B viral surface antigen （HBsAg） and its potential application in blood screening and clinical surveillance. Methods Missed detection rate of CLIA was compared with that of available imported ELISA kits （Murex HI＇sAg and Organon Hepanpstika@ HgsAg Uniform） , as well as domestic ELISA diagnostic kits for hepatitis 13 surface antigen of Yingke Xinchuang （Xiamen） and Shanghai Kehua on 345 serum samples which were confirmed positive for HBsAg. Serial dilutions of standard HBsAg samples were applied to evaluate the relationship between HBsAg concentration and relative light units （RLUs） and to assess the stability of CLIA detection. Results The missed detection rate of CLIA was significantly higher than that of Murex and Organon kits （P〈0.01）, however there was no significant difference on comparing the results of two domestic ELISA kits. The serial dilutions of standard serum HBsAg （0. 5- 150 ng/ml） of CLIA showed good linear correlation between HBsAg concentration and RLUs. Repeat CLIA assay with low, medium and high concentration of HBsAg produced good stability within parallel wells and plates. Conclusion The detection of serum HgsAg by CLIA shows advantages on rapid detection, quantitative analysis and good reliability. The domestic CLIA kit is applicable in detection of HBsAg in blood screening and clinical applications.