Objective To establish the quality standard and assessment method for a human K-ras gene mutation detection kit. Methods Using the real-time fluorescent quantitation PCR method, seven K-ras gene mutation controls were evaluated for the accuracy, specificity, detection limit and reproducibility. Meanwhile, seven K-ras gene mutation-positive samples and ten negative samples from patients with colorectal cancer were assessed for the accuracy and specificity. Results All kinds of single point mutations could be accurately and specifically detected, and the properties involving the accuracy, specificity, detection limit and reproducibility were complied with the established quality standard. Conclusion The quality standard for the human K-ras gene mutation detection kit can be reasonable and the kit will have a good prospect in guiding the detection of K-ras gene mutation.%目的 评价和分析一种新的人类K-ras基因突变检测试剂盒质量,确定该类试剂质量标准和评价方法.方法 利用实时荧光定量PCR方法,检测7种K-ras基因单一突变点质控品的准确性、特异性、最低检测量和重复性.分别检测7例肠癌患者K-ras基因突变阳性组织样本和10例阴性样本的准确性和特异性.结果 试剂盒准确性、特异性、最低检出量和重复性均符合质量标准.能准确和特异的检出单一点突变,具有较好的灵敏度和重复性.结论 该试剂盒质量标准设定较合理,在指导K-ras基因突变检测方面具有较好的应用前景.
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