ELISA方法筛查TORCH感染的质量控制方法探讨  

Study on quality control of ELISA method for screening TORCH infection

作　　者：迟绍琴[1] 陈奕微 师宏词[1] 孙宇飞[1] 郑立新 

机构地区：[1]深圳市龙岗区计划生育服务中心,广东深圳518172 [2]广东省计划生育科学研究所,广东广州510000

出　　处：《国际检验医学杂志》2015年第24期3550-3551,共2页International Journal of Laboratory Medicine

摘　　要：目的探讨实验室定性检测TORCH感染指标(风疹病毒IgG、巨细胞病毒IgG和IgM、弓形虫IgG和IgM,简称五项)的室内质量控制方法。方法采用统计学方法,正态分布数据,用ELISA方法检测的阳性率比值和标准差,设定1+2s为失控规则,绘制半Lerey-Jennings质控图;非正态分布数据、小概率事件,则采用直接概率计算法,回顾分析57批次的检测数据。结果风疹病毒IgG阳性率为86.66%、巨细胞病毒IgG/IgM的阳性率为98.87%和0.13%、弓形虫IgG/IgM阳性率为2.43%和1.71%,五项指标在临界值范围的分别有151、3、5、176、27个标本数据。失控次数为巨细胞病毒IgG 1次,弓形虫IgG/IgM分别是1次和4次。结论 ELISA定性检测TORCH感染指标的室内质控,可以采用日常检测阳性率或阴性率数据监控假阳性。临界值范围的标本应当进一步复检或确认实验。Objective Onto investigate the indoor quality control method for qualitatively detecting the laboratory indicators of TORCH infection（rubella virus IgG,cytomegalovirus IgG and IgM,toxoplasma IgG and IgM）.Methods The statistical method,normal distribution data,ratio and standard deviation of positive rate detected by the ELISA method were adopted,1＋2s was set as the out of control rules,the semi Lerey-Jennings quality control chart was drawn;the direct probability calculation method was adopted for the non-normal distribution data and small probability event.The testing data of 57 batches were retrospectively analyzed.Results The positive rate of rubella virus IgG was 86.66%,cytomegalovirus IgG/IgM positive rates were 98.87% and0.13%,toxoplasma gondii IgG/IgM positive rates were 2.43% and 1.71%,the data of 151,3,5,176,27 samples had the critical value range of five indicators.The number of out of control was once for cytomegalovirus IgG,once and 4times for Toxoplasma gondii IgG/IgM.Conclusion The indoor quality control for the ELISA qualitative detection of TORCH infection can adopt the data of daily detection positive rate or negative rate for monitoring the false positive.The critical value range of specimens should be further conducted the recheck or confirmation experiment.

关 键 词：酶联免疫吸附试验 定性检测 TORCH 室内质控 

分 类 号：R446.6[医药卫生—诊断学]