两种HBVM诊断试验ELISA检测试剂盒的性能评价与比较

Evaluation and Comparision of the Performance of the Diagnostic Tests of two One-step ELISA Qualitative Detection Kits for Hepatitis B Virus Serum Markers

目的建立乙型肝炎标志物酶联定性诊断试剂盒的方法学性能评价方案和实验方法。方法利用受试者工作曲线（ROC）科学、合理的确定新创和理利两种酶联免疫定性检测试剂盒检测结果判定的截断点（阚值），同时将此实验结果与厂商提供的结果判定标准相比较，观察该两种试剂盒在不同截断点下的诊断效度、信度和诊断价值的差异。结果两种酶联免疫试剂测定HBV-M在ROC截断点下新创试剂检测HBs＆Ag，HBsAb，HBeAg诊断试验的效度、信度和诊断价值均明显优于理利试剂，而检测HBcAb则不如理利试剂，检测HBeAb两者却相似。在厂商截断点下，新创试剂检测HBV—M的效度、信度和诊断价值明显比理利试剂强。无论以A还是COI为结果判定的指标，只要阴性内对照A结果稳定，各试剂检测HBV—M的LLD的结果是基本一致的；新创试剂的LLD要比理利试剂的低；ROC曲线截断点确定的LLD比厂商提供截断点所确定的LLD要低。新创试剂检测HBv—M除阴性结果外，稳定性均比理利试剂好。两种一步夹心法酶联免疫试剂检测HBsAg，HBsAb和HBeAg的高值标本均存在钩状效应（带现象），理利试剂的钩状效应比新创试剂更明显。但两种试剂的一步免疫抑制竞争法检测HBeAb和HBcAb均无明显的钩状效应。结论酶联免疫定性检测HBV—M诊断试验的效度、信度和诊断价值的评价与比较是其试剂盒检测性能评价与产品质量比较的重要方面。诊断试验的ROC曲线是HBV—M酶联试剂截断点分析、检测性能评价、产品质量比较的重要工具，值得厂商借鉴和临床推广应用。

Objective To establish a methodological performance evaluation project and experimental methods for two onestep ELISA qualitative detection kits of Hepatitis B Virus Serum Markers. Methods The optional cutoff points for determinant results of the two ELISA qualitative detection kits by Xinchuang and Lili Co. Ltd. were chosen scientifically and reasonally by ROC,meanwhile this experimental results were compared with the result decision criterion supplied by manufacturer ,the differences of diagnostic validity ,reliability and diagnostic value of the two kits in different cutoff points were observed. Results The validity,reliability and diagnostic value of diagnostic tests,in the cutoff points chosen by ROC,of HBsAg,HBsAb and HBeAg detected by ELISA kits from Xinchuang were all more excellent significantly than those from Lili ,while those of HBcAb detected by ELISA kits from Xinchuang were all not as good as those from Lili ,and ,however, those of HBeAb detected by the both kits were similar to each other. The validity,reliability and diagnostic value of diagnostic tests of Ht3V-M detected by ELISA kits from Xinchuang were all more excellent evidently than those from Lili both in the cutoff points supplied by the manufacturers. No matter what result decision criterion such as OD or COl was taken, so long as the OD detection results of the negative inner control was kept steady relatively,the LLD outcome of each HBV- M item detected by each reagent kit of the either manufacturer was basically unanimous for each item. The LLDs of Xinchuang reagents were lower than those of Lili＇s. The LLDs decided by the cutoff points of ROC were lower than those decided by the cutoff points supplied by manufacturers. The steadibility of the HBV-M detection results except from negative results by Xinchuang reagents was better than that by Lili＇ s. There were both high-dose hook effects （zone phenomenon） in high concentration samples of HBsAg,HBsAb and HBeAg detected by two kinds of one-step sandwich ELISA reagent kits, but no the effects in high concentration samples of HBeAb and HBcAb detected by two kinds of one-step methods of the competitive enzyme-linked immunoinhibition assay. The hook effects of ELISA reagent kits from Lili were stroner than those from Xinchuang. Conclusions Evaluation and comparision of validity,reliability,diagnostic value of diagnostic tests of HBV-M detected by ELISA qualitative reagent kits were the most important sides to evaluate the detection performance of those reagent kits in clinics and to compare the products quality of different manufacturers. The ROC based on diagnostic tests was the most important tool for the analysis of cutoff points of HBV-M detected by ELISA reagent kits,the evaluation of detection performance and the comparision of products quality,which was worth using for reference by manufacturer,generalizing and applying by laboratorian in clinics.