血站核酸检测实验室HBV DNA项目室内质量控制方法探讨

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Lev...

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

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.