两种检测策略在细胞库病原体污染的检出分析  

Analysis of two detection strategies in the detection of pathogen contamination in cell bank

作　　者：曾劲峰[1] 梅秋红 张耿[1] 邬林枫[1] 李然 许晓绚[1] 赵钰 熊文[1] 刘沐芸 王立林[1] ZENG Jinfeng;MEI Qiuhong;ZHANG Geng;WU Linfeng;LI Ran;XU Xiaoxuan;ZHAO Yu;XIONG Wen;LIU Mu Yun;WANG Lilin(Shenzhen Blood Center,Shenzhen,Guangdong,China,518035;Shenzhen Kono Medical Laboratory,Shenzhen,Guangdong,China,518057)

机构地区：[1]深圳市血液中心,广东深圳518035 [2]深圳科诺医学检验实验室,广东深圳518057

出　　处：《分子诊断与治疗杂志》2021年第9期1419-1422,共4页Journal of Molecular Diagnostics and Therapy

基　　金：广东省医学基金项目(A2020259);深圳市医学重点学科建设经费(SZXK070);深圳市医疗卫生三名工程项目(SZSM201811092)。

摘　　要：目的比较临床检测策略(CDS)与血筛检测策略(BSS)在综合细胞库供体病原体检测中的差异,进行研究分析。方法对深圳综合细胞库2016年2月至2017年7月共计7 981例细胞供者的血浆标本进行病原体检测,病原体类型包括乙型肝炎病毒(HBV)、丙型肝炎病毒(HCV)、人类免疫缺陷病毒(HIV1/2)与梅毒螺旋体(TP)四类。实验采用CDS和BSS两种检测策略进行。分析两者在病原体总体检测结果及各单项检测结果的一致性,比较两种检测策略的差异性。同时分析BSS中血清学ELISA与核酸检测(NAT)方法对HBV、HCV、HIV检测结果的一致性,比较两者的差异性。结果 BSS与CDS两种检测策略的一致性一般(K=0.563),差异有统计学意义(P<0.05)。两种检测策略中,HBV的一致性一般(K=0.528),HCV的一致性很差(K=0.105),HIV1/2的一致性很差(K=0);比较BSS中血清学检测方法与核酸检测方法,两种检测方法的一致性较好(K=0.651),但两种方法差异有统计学意义(P<0.05),其中HBV的血清学检测与核酸检测两种方法的一致性非常好(K=0.833),而HCV与HIV血清学检测与核酸检测两种方法的一致性较差(K<0.4)。结论 BSS在细胞供者病原体检测种类上更全面,检测灵敏度更高;在细胞库病原体污染风险防控中应同时重视两种检测方法试剂的选择,整体上降低任何单一检测方法不准确导致的病原体漏检风险,避免病原体交叉污染,保证细胞库储存样本安全。Objective To compare the difference between the clinical detection strategy(CDS)and the blood screening strategy(BSS) in the comprehensive cell bank pathogen detection.Methods A total of 7 981 plasma samples from cell donors in Shenzhen Comprehensive Cell Bank were tested for pathogens from February 2016 to July 2017.The types of pathogens include hepatitis B virus(HBV),hepatitis C virus(HCV),and human immunodeficiency virus(HIV 1/2) and Treponema pallidum(TP).Two detection strategies,CDS and BSS,were used in the experiment.The consistency of the overall detection results and individual detection results of the two methods were analyzed,and the differences of the two detection strategies were compared.At the same time,the consistency of BSS serological ELISA and nucleic acid Testing(NAT) methods in BSS for HBV,HCV and HIV detection results were analyzed,and the differences between the two were compared.Results The consistency between BSS and CDS detection strategies was general(K=0.563),and the difference was statistically significant(P<0.05).In the two detection strategies,the consistency of HBV was general(K=0.528),the consistency of HCV and HIV1/2 was very poor(K=0.105 and 0).Comparing the serological detection method and nucleic acid detection method in BSS,the consistency of the two detection methods is good(K=0.651),the difference between the two methods is statistically significant(P<0.05),among which the serological detection of HBV is the same as the nucleic acid detection method.The consistency of the two detection methods is very good(K=0.833),while the consistency of the two methods of HCV and HIV serological detection and nucleic acid detection is poor(K<0.4).Conclusion BSS is more comprehensive in the detection of cell donor pathogens,and the detection sensitivity is higher.In the prevention and control of cell bank pathogen contamination risk,attention should be paid to the choice of two detection methods and reagents,so as to reduce the missed detection of pathogens caused by inaccuracy of any sin

关 键 词：血筛检测策略 临床检测策略 血清学检测 NAT ELISA 

分 类 号：R446.5[医药卫生—诊断学]