Department of Clinical laboratory, Renmin Hospital of Wuhan University, Wuhan Hubei, China.
J Clin Lab Anal. 2013 Jul;27(4):294-6. doi: 10.1002/jcla.21600.
Comparison of diagnostic efficiency of four ELISA kits for determining HBsAg.
Collecting 348 serum samples from clinical laboratory of Renmin Hospital of Wuhan University without specific gender and age requirements, determining HBsAg by the four ELISA kits, simultaneously. Confirmatory test was carried out when the initial results are positive.
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 can be confirmed; 19 samples were not consistent (5.5%), and only 1 sample was confirmed by the confirmatory test. After calculation, the diagnostic efficiencies of the four ELISA kits (Beijing Wantai, Xiamen Xinchuang, Zhuhai Lizhu, and Shanghai Kehua) were 98.6%, 98.0%, 99.7%, and 97.4%, respectively, the sensitivities were 100%, 99.4%, 99.4%, and 100%, respectively, the specificities were 97.5%, 96.9%, 100%, and 95.4%, respectively, the false positive rates were 2.5%, 3.1%, 0, and 4.6%, respectively, and the false negative rates were 0, 0.6%, 0.6%, and 0, respectively. All the initial absorbencies of the false positive samples were less than 1.0.
The diagnostic efficiency of Lizhu is the highest, while Kehua is the lowest. False positive or false negative results would take place in any of the kits, an HBsAg confirmatory test is essential for initially positive samples, especially with absorbance <1.0, because it can exclude most false positives.
比较四种 ELISA 试剂盒检测 HBsAg 的诊断效率。
收集武汉大学人民医院临床实验室无特定性别和年龄要求的 348 份血清样本，同时使用这四种 ELISA 试剂盒检测 HBsAg。对初筛阳性的样本进行确证试验。
348 份样本中有 329 份（94.5%）结果一致，329 份中 152 份为阳性，177 份为阴性，且所有阳性结果均可被确证；19 份结果不一致（5.5%），仅 1 份样本经确证试验确证。经计算，四种 ELISA 试剂盒（北京万泰、厦门新创、珠海丽珠和上海科华）的诊断效率分别为 98.6%、98.0%、99.7%和 97.4%，灵敏度分别为 100%、99.4%、99.4%和 100%，特异性分别为 97.5%、96.9%、100%和 95.4%，假阳性率分别为 2.5%、3.1%、0 和 4.6%，假阴性率分别为 0、0.6%、0.6%和 0。所有假阳性样本的初筛吸光度均小于 1.0。
丽珠的诊断效率最高，科华最低。任何试剂盒均可能出现假阳性或假阴性结果，对于初筛阳性的样本，尤其是吸光度<1.0 的样本，进行 HBsAg 确证试验非常必要，因为它可以排除大多数假阳性。
