【作者】 刘艳； 黄杰； 张春涛； 高尚先； 阮力； 陈琰；

【Author】 Liu Yan1,Huang Jie1,Zhang Chun-tao1,Gao Shang-xian1,Ruan Li2,Chen Yan2 (1.National Institute for the Control of Pharmaceutical and Biological Products,Beijing 100050,China; 2. Amoy Diagnostics Co.,Ltd,Xiamen 3610266,China)

【机构】 中国药品生物制品检定所； 厦门艾德生物医药科技有限公司；

【摘要】 目的:对一种新的人类K-ras基因突变检测试剂盒进行质量评估和结果分析。方法:利用实时荧光定量PCR方法,对7种K-ras基因单一突变点质控品进行准确性、特异性、最低检测量和重复性的检测。同时,对7例肠癌病人K-ras基因突变阳性的组织样本和10例阴性样本分别进行准确性和特异性检测。结果:对试剂盒准确性、特异性、最低检出量和重复性的检测均符合要求。能够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:实时荧光定量PCR方法在检测K-ras基因突变并指导临床应用方面具有较好的应用前景。更多还原

【Abstract】 Objective:To assess a new human K-ras gene mutation detection kit and further analysis of results. Methods:Using real time quantitative PCR method, seven kinds of K-ras gene mutation in a single point of control materials for accuracy, specificity, and the detection volume and repetitive testing. Meanwhile, seven cases of patients with colorectal cancer K-ras gene mutation-positive tissue samples and 10 samples were negative for the accuracy and specificity of detection. Results:The accuracy, specificity, detection limit and repeatability of the kit are complied with the testing requirements. Can be accurate and specific detection of single point mutations, and has good sensitivity and repeatability. Conclusion:Real-time fluorescence quantitative PCR method to detect K-ras gene mutation and clinical application of the guidance has good application prospects.更多还原