血液筛查核酸检测系统的性能验证及评价研究  

Study on verification and evaluation for the performance of a nucleic acid test system of screening blood

作　　者：杜文功 马兴焕 殷鹏 王培培 刘娟 Du Wengong;Ma Xinghuan;Yin Peng;Wang Peipei;Liu Juan(Langfang Center Blood Bank,Langfang 065000,China;National Joint Engineering Research Center for Infectious Diseases and Cancer Diagnosis,Changsha 410205,China)

机构地区：[1]廊坊市中心血站,廊坊065000 [2]感染性疾病及肿瘤基因诊断技术国家地方联合工程研究中心,长沙410205

出　　处：《中国医学装备》2024年第10期19-23,共5页China Medical Equipment

摘　　要：目的:对一种国产血液核酸检测系统用于血液筛查的主要性能指标及其应用价值进行评价,以确保血站系统血液筛查的安全。方法:收集2022年1月廊坊市中心血站20份阴性血浆样本,同时收集2022-2023年廊坊血站采集的无偿献血者6703例血液标本,并依据《血站技术操作规程(2019)版》与医药行业标准《核酸扩增检测用试剂(盒)》要求,对核酸检测系统的稳定性、分析特异性、灵敏度、精密度、抗干扰能力、抗交叉污染能力的性能进行验证,进行临床应用分析。结果:该血液筛查核酸检测系统对20例血浆样本阴性检测的结果符合率为100%;乙肝病毒脱氧核糖核酸(HBVDNA)、丙型肝炎病毒核糖核酸(HCV RNA)、人类免疫缺陷病毒核糖核酸(1+2)(HIV 1+2 RNA)的灵敏度检测结果符合率均为100%,精密度变异系数百分比(CV%)分别为1.57%、0.75%、1.49%。该系统进行核酸检测时,血红蛋白浓度水平为400 mg/dl的溶血血浆及甘油三酯浓度水平为3000 mg/dl的脂肪血标本对低浓度水平的HBV-DNA(9.0 IU/ml)、HCV-RNA(30.0 IU/ml)和HIV-RNA(135.0 IU/ml)标准物质的分析性能均无显著影响。10份高浓度(1000 IU/ml)的阳性样本与11份阴性样本交叉排列进行检测时无交叉污染现象。6703例标本混样模式下经核酸检测技术(NAT)共检测出16例反应性标本,占0.24%。结论:核酸检测系统在投入使用前要做性能验证以保证血液筛查的安全。目前的国产核酸检测系统能够满足血液安全筛查的要求。核酸检测系统的性能验证对于保证血液筛查安全具有重要价值。Objective:To evaluate main performance indexes and application value of a domestic blood nucleic acid test system for blood screening,so as to ensure the safety of blood screening in the system of blood bank.Methods:Twenty samples were selected from Langfang Center Blood Bank in January 2022,and 6703 blood specimens of voluntary blood donors from Langfang Blood Bank between 2022 and 2023 were simultaneously selected.According to the requirements of the"Technical Operating Procedures for Blood Stations(2019 Edition)"and the standard for medical medicine industry"Nucleic Acid Amplification Test Reagents(kits)",the performances of stability,analytical specificity,sensitivity,precision,anti-interference ability and against cross-contamination ability of nucleic acid test system were verified for the analysis of clinical application.Results:The coincidence rate of the nucleic acid test system was 100%for 20 negative plasma samples.The coincidence rates of the sensitivities of Hepatitis B virus deoxyribonucleic acid(HBV DNA),Hepatitis C virus ribonucleic acid(HCV RNA)and Human immunodeficiency virus ribonucleic acid(1+2)(HIV 1+2 RNA)were respectively 100%,and percentages of the coefficient of variation(CV%)of the precision of them were respectively 1.57%,0.75%and 1.49%.When the system conducted nucleic acid test,the hemolytic plasma with a hemoglobin concentration level of 400mg/dl and the blood specimen with triglyceride concentration levels of 3000mg/dl did not affect the analysis performances of the standard substances of HBV-DNA(9.0IU/ml),HCV-RNA(30.0IU/ml)and HIV-RNA(135.0 IU/ml)of low concentration level.There were not cross-contaminations when 10 positive samples at high concentration(1000 IU/ml)were cross-lined with 11 negative samples to conduct test.A total of 16(0.24%)reactive specimens were checked out from 6703 specimens by Nucleic Acid Test(NAT)Technique under mixed mode.Conclusion:Nucleic acid test system must conduct performance verification before it is put into use,so as to ensure the safety of blood

关 键 词：血液筛查 核酸检测 性能验证 

分 类 号：R446.113[医药卫生—诊断学]