血站核酸定性检测实验室统计学质量控制方法的建立

Establishment of laboratory statistical quality control methods fornucleic acid detection of blood centers

目的建立血站实验室8人份PCR混检和TMA单人份三联检两类核酸定性检测系统的室内质控统计学控制方法,用以监测日常检测工作的稳定性。方法收集2019年1-8月CHITAS12000/ABI7500 PCR核酸扩增系统外部质控品的HIV/HCV/HBV混检检测结果的Ct值和Procleix TIGRIS核酸检测系统外部质控品的HIV/HCV/HBV联检S/CO值。对数据进行正态分布检验,判断是否可以使用基于数据正态分布的统计学质量控制方法。符合正态分布的项目绘制Levey-Jennings质控图,不符合正态分布的项目采用指数加权移动平均(exponential weighted moving average,EWMA)质控图对外部质控品检测S/CO值进行分析。结果浩源PCR混检系统HIV、HCV和HBV外部质控品混合检测Ct值符合正态分布,利用Levey-Jennings质控图可以监测实验稳定性。TGRISTMA检测系统HIV、HCV和HBV外部质控品联检S/CO值均不符合正态分布。利用EWMA质控图对外部质控品核酸联检S/CO值的波动情况进行监控。结论利用8人份浩源混检外部质控品Ct值和单人份TIGRIS联检系统外部质控品的S/CO值,分别采用Levey-Jennings质控图和EWMA质控图对血站核酸定性检测系统进行稳定性监测具有可行性。

Objective To establish the statistical quality control methods for two nucleic acid qualitative detection system of minipool(8 samples a pool)PCR NAT and individual triplex TMA NAT,to monitoring the stability of daily inspection work.Methods The Ct values of HIV/HCV/HBV of external quality controls detected by of CHITAS12000/ABI7500 PCR nucleic acid detection system and S/CO values of HIV/HCV/HBV of external quality controls detected by Procleix TIGRIS Nucleic acid detection system,those were detected during January to August in 2019 were collected.The normal distribution of the data is tested to determine whether the statistical quality control methods which based on the normal distribution of data can be used.Using Levy-Jennings quality control chart to analysis the values which conform to the normal distribution and using exponential weighted moving average(EWMA)quality control chart to analysis the values which do not conform to the normal distribution.Results The Ct values of HIV-1 RNA,HCV RNA and HBV DNA of external quality control that detected by Haoyuan system conformed to normal distribution,so the experimental stability can be monitored by using Levy-Jennings quality control chart.The external quality control S/CO value of HIV-1 RNA,HCV RNA and HBV DNA that detected by TGRISTMA system do not conform to normal distribution,so using EWMA quality control chart to monitor the fluctuation of the S/COvalue of the external quality control products.Conclusions Using Haoyuan Nucleic acid detection system to obtain the minipool(8 samples a pool)PCR NAT Ct values of the external quality control product and TIGRIS Nucleic acid detection system to obtain the individual triplex TMA NAT s/co values of the external quality control product,and using the Levy-Jennings quality control chart and the EWMA quality control chart to monitor the stability of the two blood station NAT systems are feasible.