【摘要】 目的可提取核抗原抗体(ENA)的性能验证。方法对免疫印迹法检测的可溶性核蛋白抗体重复性和准确度进行评价。批内重复性验证:用6份特征性患者血清样本(5份阳性,1份阴性)对同一批号的产品进行检测,每份血清检测5次,比较阳性血清检测的结果,要求特异性抗体检出结果基本一致,阴性血清检测的结果为阴性;批间重复性验证:在3d内,用6份特征性患者血清样本(5份阳性、1份阴性)对同一批号的产品进行检测,每份血清每次复管检测1次,统计其阴阳性符合率;批批重复性验证:用6份特征性患者血清样本(5份阳性、1份阴性)对近3个月内所有不同批号的试剂进行检测,统计1年内所检测不同批号试剂的阴阳性符合率;阴性、阳性符合率:将100份已检测过的患者标本,其中阴性50份,阳性50份,重新检测1次,分别统计阴性、阳性重复检测结果的一致率。准确度验证:统计分析近3年参加卫生部临床检验中心及其他单位组织的室间质评结果与本室检测结果的阴性和阳性符合率。结果批内、批间、批批及100份患者标本的阴性、阳性符合率均为100%。结论本室免疫印迹法检测可溶性核蛋白抗体的重复性、准确度能满足实验性能验证的要求。更多还原

【Abstract】 OBJECTIVE To evaluate immunoblotting kit method detecting ENA antibody. METHODS To evaluate the repeatability and accuracy of immunoblotting kit to detect ENA antibody. Within-run repeatability: six patient samples (one negative and five positive samples) were repeated 5 times for detection in the same experiments, and the consistent rate of positive and negative was statistically analyzed. Inter-repeatability: six patient samples (one negative and five positive samples) were repeated in three days and the consistent rate of positive and negative was statistically analyzed. Batch-batch repeatability: six patient samples (one negative and five positive samples) were repeated to test the different batches of reagents, and the consistent rate of positive and negative of a year was statistically analyzed. 50 negative patients and 50 positive patients were repeated in different batches, and the consistent rate of positive and negative was statistically analyzed. Accuracy was to statistically analyze the consistent rate of positive and negative of EQA data. RESULTS The negative and positive consistent rate of intra, inter detection and batch-batch detection were 100% ; The negative and positive consistent rate of EQA data were 100%. CONCLUSION The repeapeability and accuracy of the immunoblotting kit method to detect ENA antibody in our laboratory could meet the detect performance.更多还原