血站核酸检测实验室HBV DNA项目室内质量控制方法探讨

Internal quality control of HBV DNA determination in blood center nucleic acid laboratory

目的探讨血站核酸检测实验室乙型肝炎病毒(HBV)DNA项目室内质量控制(IQC)方法。方法以HBV DNA阳性质控品、试剂盒阳性对照为反应性,试剂盒阴性对照为阴性,且内标阳性为实验在控。根据3个月的检测数据,分别计算阳性质控品循环域值(Ct)、阳性对照Ct值、内标Ct均值、内标Ct值标准差的均值和标准差,绘制Levey-Jenning质控图,使用Westgard多规则质控方法进行判断。统计检测标本总数及混样反应性、拆分反应性次数,计算总体监控指标(混检阳性率、拆分阳性率、拆出率)。结果所有批次实验均在控。阳性质控品Ct值在第32天、内标Ct均值在第30天和第58天发生1_(3s)失控,内标Ct值标准差在第27天发生22s失控、在第58天发生R4s失控。共检测标本14172份,其中HBV DNA混样反应性13次,拆分反应性8次,混检阳性率、拆分阳性率和拆出率分别为0.092%、0.056%、61.540%。结论血站血液筛查日常检测时,在使用HBV DNA阳性质控品判定当批实验在控的基础上,结合阳性质控品Ct值、试剂盒阳性对照Ct值、内标Ct均值、内标Ct值标准差的Levey-Jenning质控图及总体监控指标进行回顾性分析,可以有效进行血站HBV DNA检测的IQC。

Objective To investigate the internal quality control(IQC)of hepatitis B virus(HBV)DNA determination in blood center nucleic acid laboratory.Methods The experiment was effective when quality control(QC)and positive control(PC)were positive,and negative control(NC)was negative.The average value,standard deviation and coefficient of variation of QC cycle threshold(Ct),PC Ct,VIC Ct and VIC Ct SD were calculated.Draw Levey-Jenning QC chart was drawed.Westgard multi-rules were used.The total number of samples,mixed reactivity and split reactivity were evaluated.The general monitoring was performed(minipool nucleic acid test positive ratio,positive split ratio and effective split ratio).Results Every experiment was effective in 3 months.QC Ct in day 32,VIC Ct in day 30 and 58 was out of control by rule 1_(3s).VIC Ct SD was out of control in day 27 by 22s and day 58 by R4s.Total number of samples,mixed reactivity and split reactivity were 14172,13 and 8,respectively.Minipool nucleic acid test positive ratio,positive split ratio and effective split ratio were 0.092%,0.056%and 61.54%,respectively.Conclusions It could be applied effectively for blood center to use QC as IQC and Levey-Jenning QC chart of QC Ct,PC Ct,VIC Ct and VIC Ct SD combined with general monitoring indicators.