3种KRAS基因突变检测试剂盒的质量评价

Quality Evaluation of Three KRAS Gene Mutation Detection Kits

为了解市场上KRAS基因突变检测试剂盒的质量,指导试剂盒的选择和使用,选择了常见的3种试剂盒(随机编号A、B和C)对其进行质量评价。使用标准物质分别对试剂盒的准确度、特异性、检出限和重复性指标进行了评价。评价结果分别为:3种试剂盒的准确度均较好,对7个突变型的阳性符合率验证结果均为100%;3家实验室的特异性验证结果中,每种试剂盒都有假阳性结果检出,3种试剂盒中均不能满足7个突变型的阴性符合率为100%,阴性符合率为100%的突变型结果中,试剂盒A有6个,试剂盒B有6个,试剂盒C有3个;检出限评价结果表明,3种试剂盒对7个突变型的实际检出限与所标识的检出限(1%)不完全一致,其中3家实验室验证一致且与标识检出限相符的突变型,试剂盒A有0个,试剂盒B有3个,试剂盒C有5个;试剂盒的低水平重复性均较好(<5%)。

In order to understand the quality of the human KRAS gene mutation detection kit,and to guide the selection and use of the kit,three kits commonly available on the market(random numbered A,B and C)were used for quality evaluation.The accuracy,specificity,detection limit and repeatability of the kits were evaluated using standard materials.The positive rate of the seven mutants was 100%,which indicated the accuracy of the kits was good.The specific verification results of the three laboratories showed that the three kits could not meet the negative coincidence rate of 100%mutants,that is,each kit had a false positive result,and the number of mutants with a negative coincidence rate of 100%:6 for kit A,6 for kit B,and 3 for kit C.The results of the detection limit showed that the actual detection limits of the seven mutants were not exactly the same as the identified detection limits(1%).And the number of mutants in the three laboratories that were consistent and consistent with the detection limit:0 for kit A,3 for kit B,and 5 for kit C.The low level repeatability of all the kits were good(<5%).