基于日常检测结果的核酸扩增检测假阳性统计室内质量控制方法  

Statistics internal quality control method for false-positive in clinical nucleic acid amplification tests based on positive rates of routine testing

作　　者：李金明[1] 林尊慧[2] 王露楠[1] 靳海英[2] 彭建明[1] 王忠芳[1] 邓巍[1] 

机构地区：[1]卫生部北京医院卫生部临床检验中心临床免疫室,100730 [2]北京佑安医院

出　　处：《中华检验医学杂志》2006年第3期275-277,共3页Chinese Journal of Laboratory Medicine

摘　　要：目的建立一种利用核酸扩增检验实验室日常检测数据进行定性测定假阳性监测的实验室室内质量控制方法。方法以实验室日常不少于20次检测的阳性率比值为基础,计算阳性率比值的均值(x)和标准差(s),绘制质控图,以1+2S为“告警”规则,1+3S和3+2S为失控规则。结果对实验室212次HBVDNA聚合酶链反应(PCR)实测数据分析,x和s分别为0.527和0.078,与前20次测定的x(0.532)和s(0.09)相近。212次测定中,出现5次超出x±2s,按照所定的质控规则有两次失控。符合统计上的正态分布。结论为核酸扩增常规检测提供了一种具有可操作性的假阳性统计室内质控方法。Objective To establish a statistics internal quality control method for routine tests of clinical nucleic acid amplification laboratories. Methods Based on the positive rates ot more than 20 resultsof routine tests, the mean value （x^-） and standard deviation （s） were calculated and the quality control chartwas plotted. The control rules are 1 ＋2s for warning, and 1 ＋3s and 3 ＋2s for out-of-controL Results The x^- ands of positive rate among 212 polymerase chain reaction （PCR） test runs for hepatitis B virus （HBV） DNAwere 0. 527 and 0. 078 that similar to those （0. 532 and 0. 09） of first 20 test runs. Among 212 test runs,total five＇s positive rate value are more than x^-±2s. There were two test results being out-of-control accordingto the control rules. The data possessed characteristics of normal distribution. Conclusion The proposedinternal quality control statistics method for false-positive monitoring in nucleic acid amplification routinetests is practical and useful.

关 键 词：核酸扩增技术 假阳性反应 室内质量控制 

分 类 号：R450[医药卫生—治疗学]