内标在高原地区血液核酸检测系统的稳定性评价分析  

Stability of two internal control blood nucleic acid detection systems in plateau area

作　　者：加央扎西 曲吉 章伟华 陈少彬[3] Jiayangzhaxi;Quji;ZHANG Weihua;CHEN Shaobin(Blood Center of Tibet Autonomous Region,,Lasa 850012,China;Linzhi Blood Center;Dongguan Blood Center)

机构地区：[1]西藏自治区血液中心,西藏拉萨850012 [2]林芝市中心血站 [3]东莞市中心血站

出　　处：《中国输血杂志》2021年第5期525-528,共4页Chinese Journal of Blood Transfusion

摘　　要：目的分析2套血液核酸单检系统的内标(IC)Ct值差异,探讨IC Ct值用于核酸检测系统稳定性评价指标的可行性。方法随机抽取本中心2020年6~11月共4342份血液标本的核酸检测IC的Ct值,对核酸检测系统的IC Ct值分别按3种分类:1)检测项目分类:HBV、HCV和HIV;2)按标本类型分类:阴性对照(NC)、阳性对照(PC)、室内质控(QC)、献血者标本(S);3)按不同仪器分类:A系统和B系统进行分析,比较各IC Ct值的差异。结果共收集14196个核酸测试的IC Ct值,经正态性检验其分布情况呈非正态分布,1)按检测项目分类:HBV、HCV和HIV的总体IC的Ct值中位数比较均不同(H=859.6,P<0.01),分别为29.59(29.09,30.17)、29.82(29.32,30.06)和30.16(29.55,30.78);2)按标本类型分类:NC、PC、QC和S的IC Ct值中位数也均不同(H=1158,P<0.01)分别为28.91(28.29,29.42)、31.49(30.45,32.30)、29.13(28.59,29.70)和29.88(29.33,30.44);3)相同的检测项目(标本类型)在2套核酸检测系统的IC结果,除HBV的QC(Z=1635)和S(Z=1848560)、HCV的S(Z=1957844)、HIV的S(Z=2217855)不同(P<0.01)外,其他的检测项目IC结果的差异均无统计学意义(P>0.05);而在同一套检测系统中,不同检测项目(NC、PC、QC、S)的IC检测值不全相同(P<0.01)。结论不同类型标本在核酸单检系统的IC Ct值存在差异,但原装试剂配套的NC、PC、QC标本在2套检测系统的IC Ct值较一致;监测IC Ct值变化可能作为核酸检测系统稳定性的评价指标。Objective To analyze the difference of the internal control(IC)Ct value of two sets of blood nucleic acid detection(NAT)systems for individual donation and explore the feasibility of the IC Ct value used as stability evaluation index of NAT system.Methods A total of 4342 blood samples were randomly selected from our center from June to November 2020,and the IC Ct values of NAT system were classified into three categories:1)classified by detection items:HBV,HCV and HIV;2)classified by sample type:negative control(NC),positive control(PC),internal quality control(QC),blood donor sample(S);3)classified by different instruments:system A and system B,and the differences of IC Ct value were analyzed and compared.Results A total of 14196 IC Ct values of NAT were collected,showing a non-normal distribution.1)classified by detection items:there were differences in the median of overall IC Ct values of HBV,HCV and HIV(H=859.6,P<0.01),which were 29.59(29.09,30.17),29.82(29.32,30.06)and 30.16(29.55,30.78),respectively;2)classified by sample type:there were differences in median of overall IC Ct values of NC,PC,QC and S(H=1158,P<0.01),which were 28.91(28.29,29.42),31.49(30.45,32.30),29.13(28.59,29.70)and 29.88(29.33,30.44),respectively;3)There was no statistical significance for the IC results of the same detection items(sample type)in the two NAT systems(P>0.05),except for HBV QC(Z=1635)and S(Z=1848560),HCV S(Z=1957844),HIV S(Z=2217855)(P<0.01).No difference in IC values(P<0.01)was noted for any detection items(NC,PC,QC and S)in the same set of detection system.Conclusion Although IC values trended to be different due to types of sample,the NC,PC,and QC samples that come with the original reagents were identical in the two detection systems.The change of IC Ct value may be used as an evaluation index for the stability of the detection system.

关 键 词：内标 高原地区 CT值 核酸检测 血液检测 

分 类 号：R446.6[医药卫生—诊断学]