四种国产检测HBsAg ELISA试剂盒诊断性能的比较

摘要

目的 比较四种国产检测乙肝表面抗原ELISA试剂盒诊断性能指标.方法 收集武汉大学人民医院检验科门诊和住院患者血清样本348例,无性别和年龄要求,同时使用四种国产ELISA表面抗原试剂盒检测HBsAg,并按确证试验要求,对所有初检阳性样本执行确证试验.结果 348例血清样本,四种ELISA试剂盒检测HBsAg符合例数为329例,一致率为94.5%;其中阴性177例,阳性152例,阳性标本经确证试验其结果均为阳性;四种试剂盒检测结果不一致例数为19例,占5.5%;经确证试验仅有1例为阳性,18例阴性,经计算北京万泰、厦门新创、珠海丽珠、上海科华四种试剂盒的诊断准确度分别为98.6%,98.0%,99.7%和97.4%,灵敏度分别为100%,99.4%,99.4%和100%,特异度分别为97.5%,96.9%,100%和95.4%,误诊率分别为2.5%,3.1%,0和4.6%,漏诊率分别为0,0.6%,0.6%和0.所有假阳性样本初检吸光度值均＜1.0.结论 四种国产ELISA试剂盒诊断准确度以珠海丽珠较高,上海科华较低,但是四种试剂盒诊断性能均达到了临床对检测HBsAg的要求.所有试剂盒都会有假阳性或假阴性出现,因此无论使用哪种ELISA试剂盒,对初检结果阳性的样本都需要进行确证试验,特别是初检吸光度值小于1.0的阳性样本,以排除假阳性.%Objective Comparing the diagnostic efficiency of four domestic ELISA kits for determining HBsAg. Methods Collected 348 serum samples from clinical laboratory of Renmin Hospital of Wuhan University without specific gender and age requirements,determined HBsAg by the four domestic ELISA kits,simultaneously. Confirmatory test were carried out when the initial results was positive. Results 329 out of 348 samples results were consistent(94. 5％),152 out of 329 were positive and 177 out of 329 were negative,and all the positive results could be confirmed;19 samples were not consistent (5. 5％) ,and only 1 samples was confirmed by the confirmatory test. After calculation, the diagnostic efficiency of the four domectic ELISA kits (Beijing Wantai, Xiamen Xinchuang,Zhuhai Lizhu and Shanghai Kehua) was 98. 6％ , 98. 0％, 99. 7％and 97. 4％ , respectively. The sensitivity was 100 ％ , 99. 4％ , 99. 4％ and 100％ , respectively. The specificity was 97. 5％ ,96. 9％, 100 ％ and 95. 4％ , respectively. The false positive rate was 2. 5％, 3. 1％　,0 and 4. 6％ , respectively and the falae negative rate was 0, 0. 6 ％,0. 6 ％ and 0.respectively. All the initial absorbance of the false positive samples were less than 1.0. Conclusion The diagnostic efficiency of zhuhai Lizhu was the highest,while shanghai Kehua was the lowest. But the diagnostic performance of all the the four kits were acceptable. False positive or false negatiye results would take place in any of the kits. So a HBsAg confirmatory test is essential for samples initially positive samples,especially with absorbance ＜1. 0,because it can exclude most false positives.