摘要
Abstract
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 witb 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 diagnostie value of diagnostic tests,in the eutoff 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 HBV-M detected by ELISA kits from Xinchuang were all more excellent evidently than those f rom Lili both in the cutoff points supplied by the manufacturers. No matter what resuk decision criterion such as OD or COI was taken,so long as the OD detection results of the negative inner control was kept steady relatively,the LLD outcome of each HBVM 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 dtfferent 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.关键词
诊断试验/ROC曲线/乙型肝炎血清标志物/一步法/酶联免疫定性检测试剂盒/分析性能/评价Key words
diagnostic test/ receiver operating characteristic curve / hepatitis B virus serum markers / one-step method / enzyme-linked immunoabsorbent qualitative detection kita /analytical performance / evaluation分类
医药卫生
