3种HLA-B5801诊断试剂盒性能评估研究

Performance evaluation of three HLA-B*5801 diagnostic kits

目的分析3种不同厂家的HLA-B*5801基因分型试剂盒的检测性能,并探讨性能差异的原因。方法收集HLA-B*5801分型明确的临床样本70例,参照美国临床实验室标准化协会(CLSI)EP12-A2文件评估3种检测试剂盒的灵敏度、特异度及符合率并对试剂盒检测下限进行验证。结果3种诊断试剂盒检测结果表明,阳性样本结果一致性较高,阴性样本检测结果存在差异。3种试剂盒灵敏度均为100%;特异度分别为:100%、100%、75%;检测下限均可达到试剂盒说明书声称的最低值。结论3种诊断试剂盒性能存在一定差异,其中两种试剂盒灵敏度和特异度均较高,另一种试剂盒出现假阳性结果。

Objective To assess the detection performance of three HLA-B*5801 genotyping kits from different manufacturers,and to explore the reasons for the performance differences.Methods Seventy clinical samples of HLA-B*5801 were detected by three diagnostic kits with different detection methods.The sensitivity,specificity,coincidence rate and limit of detection of three kits were verified according to EP12-A2 document of Clinical and Laboratory Standards Institute.Results Experimental results show that the positive samples had high consistency,while the negative samples had differences.The sensitivity of the three kits was 100%,the specificity was 100%,100%,75%,and the detection limit could reach the lowest value stated in the manual of the kit.Conclusion There are some differences in the performance of the three diagnostic kits,two of which have higher sensitivity and specificity,and the other has false positive results.