两种快速检测乙型肝炎病毒表面抗原胶体金试剂的性能评价  

Evaluation of two rapid gold immunochromatographic assays for detection of hepatitis B virus surface antigen

作　　者：张敏[1] 王刚[1] 林锋[1] 张军[1] 

机构地区：[1]上海市公共卫生临床中心医学检验科,上海201508

出　　处：《中国卫生检验杂志》2013年第6期1623-1626,共4页Chinese Journal of Health Laboratory Technology

基　　金：上海市科委西医引导类项目(编号:124119a1200);上海市科委生物医药择优委托项目(课题编号:09DZ1907100)

摘　　要：目的:对两种沪产的乙型肝炎表面抗原胶体金试剂进行方法学验证和临床应用评价。方法:通过对715份临床血清标本进行测定,评价两种试剂在重复性、稳定性、特异性和准确性等方面的性能。结果:两种试剂的重复性试验结果无差异;科华试剂的检测临界点要低于荣盛试剂的检测临界点;两种试剂对存在着干扰因素的标本检测结果都出现了假阳性和假阴性。荣盛试剂的检测灵敏度为93.9%(462/492),特异度为99.6%(222/223),科华试剂的检测灵敏度为94.1%(463/492),特异度为95.1%(212/223);根据差值可信区间的计算方法可得两试剂特异性有统计学意义,灵敏度没有统计学差异。结论:两种胶体金试剂在重复性,稳定性试验方面性能良好,但在灵敏度和特异性方面还有待改善。Objective： To evaluate and validate two rapid gold for detection of hepatitis B virus surface antigen. Methods： Seven immunochromatographic assays made in Shanghai hundred and fifteen samples were tested to evaluate the two reagents in repeatability, stability, specificity and accuracy. Results： There was no difference between the two regents made by Kehua and Rongsheng in repeatability. The cut - off value of the regent made by Kehua was lower than that made by RongSheng. Both false - positive and false - negetive results were observed in the detection of samples with interfering factors by the two regents. The detection sensitivity of the regent made by RongSheng was 93.9% （462/492） and the specificity was 99.6% （222/223）, while the same index for the regent made by Kehua was 94.1% （463/492） and 95.1% （212/223, respectively. According to the method of calculating difference in value, statistical significance in the specificity of the two reagents was observed, while there was no difference in the sensitivity. Conclusion： The repeatability and stability of the two reagents are favorable, but the sensitivity and specificity may still need to be improved.

关 键 词：乙肝表面抗原胶体金试剂 性能验证 灵敏度 特异度 

分 类 号：R446.5[医药卫生—诊断学]