血液感染性病毒核酸检测室内质量控制方法的研究

Study on Internal Quality Control Method for Nucleic Acid Detection of Blood Infectious Virus

目的探讨合适血液感染性病毒核酸检测(nucleic acid testing,NAT)的室内质量控制(internal quality control,IQC)方法。方法使用北京康彻斯坦质控品(常规质控品)和澳大利亚国立血清学参比实验室(National Serological Reference Laboratory,NRL)QConnect质控品(评估质控品)进行血液感染性病毒核酸平行检测。收集2种质控品的检测结果,在常规质控方法判断为在控的检测批次中,再分别采用Westgard多规则质控方法和NRL质控限质控方法进行判断,观察2种质控方法假失控的次数和比例。结果在常规质控方法判断在控的实验批次中,再次使用Westgard多规则质控方法分析,HBV DNA,HCV RNA和HIV RNA三项仍各有0~2.46%(罗氏核酸混样检测)和0.73%~2.55%(盖立复核酸单人份检测)比例的假失控。使用NRL QConnect质控品在常规质控方法判断在控的盖立复检测批次中,使用NRL质控限进行室内质控,未发现失控情况。使用NRL QConnect质控品,在常规质控方法判断在控的罗氏检测批次中,使用NRL质控限的计算方法,计算该实验室的质控限,发现在HBV DNA和HIV RNA检测中各有1次失控(0.30%)。结论Westgard多规则质控方法不适合用于目前血站血液感染性病毒核酸检测的室内质控。该文浓度的NRL QConnect质控品和NRL质控限适合用于国内盖立复核酸单人份检测方法的室内质控,但该浓度不适合用于国内罗氏核酸混样检测。该实验室在用的室内质控方法与NRL质控限的室内质控方法,均适用于国内罗氏核酸混样检测和盖立复核酸单人份检测的室内质控。

Objective To identify suitable internal quality control(IQC)method of blood infectious virus nucleic acid testing(NAT).Methods Quality control materials from Beijing Kangchesitan Biotechnology Company(routine quality control)and Australia National serological Reference Laboratory(NRL)QConnect(evaluation quality control)were used to conduct parallel detection of blood nucleic acid.Test results from the two quality control were collected.Westgard rules and NRL QC Limits were applied to in-control test batches judged by routine method and the number and proportion of false rejection rate were identified.Results The Westgard rule quality control method was used to analyze in-control of tested batches judged by routine method in Beijing Kangchesitan quality control materials.The false control rates of HBV DNA,HCV RNA and HIV RNA were still 0 to 2.46%(Roche)and 0.73%to 2.55%(Grifols)respectively.NRL QConnect quality control material was used for nucleic acid testing of single sample(Grifols).NRL quality control limit was directly used for in-control batches judged by routine method,and no out of control situation was found.NRL QConnect quality control material was used for nucleic acid testing of mixed sample(Roche).Using NRL quality control limit calculation method,calculate the quality control limit of the laboratory with in-control of tested batches judged by routine method,only one false rejection rate(0.30%)was identified from each of the HBV DNA and HIV RNA.Conclusion Westgard rule quality control method is not suitable for internal quality control for nucleic acid testing in blood establishment.The concentration of NRL QConnect quality control material and NRL quality control limit in this paper are suitable for the internal quality control of Grifols nucleic acid single test method,but not for the mixed test of Roche nucleic acid.The internal quality control methods of nucleic acid detection in the laboratory and NRL quality control limit can be used for the internal quality control of Roche nucleic acid mixed test and Grifols nucleic acid single test.