SDC2和TFPI2基因甲基化联合检测试剂性能验证

Performance verification of SDC2 and TFPI2 gene methylation combined detection reagent

目的通过实验对黏结蛋白聚糖2(SDC2)和组织因子途径抑制剂2(TFPI2)基因甲基化联合检测试剂盒(荧光PCR法)进行性能验证,为临床实验室应用该试剂进行结直肠癌早筛提供参考。方法参考相关指南要求,通过选择符合实验条件的临床标本和参考品,通过方法符合率、检出限、精密度和抗干扰能力对试剂盒的性能进行多方面的评价。结果该试剂盒检测结果与肠镜检查和(或)病理诊断结果相比的符合率为96.7%;最低检出限为10000 copy/mL;批内、批间循环阈值变异系数≤5%;干扰物质新鲜乙二胺四乙酸抗凝血/甘油对试剂盒检测结果无影响,抗干扰能力合格。结论SDC2和TFPI2基因甲基化联合检测试剂盒(荧光PCR法)性能评估合格,可用于临床标本的检测。

Objective To verify the performance of syndecan-2(SDC2)and tissue factor pathway inhibitor 2(TFPI2)gene methylation combined detection kit(fluorescence PCR),and to provide reference for the application of this reagent in colorectal cancer early screening in clinical laboratory.Methods According to the requirements of relevant guidelines,the performance of the kit was evaluated by selecting clinical specimens and reference materials that met the experimental conditions.The method coincidence rate,detection limit,precision and antiinterference ability were evaluated.Results The coincidence rate between the detection results of the kit and colonoscopy or/and pathological diagnosis was 96.7%.The lowest detection limit was 10000 copy/mL.The coefficient of variation of cycle threshold within and between batches was≤5%;Interference material fresh ethylenediamine tetraacetic acid anticoagulant blood/glycerol has no effect on the detection results of the kit,and the anti-interference ability is qualified.Conclusion The SDC2 and TFPI2 gene methylation detection kit(fluores cence PCR)is qualified and can be used for the detection of clinical samples.