Bliss法在核酸检测分析灵敏度的建立与验证中的应用  

Application of Bliss method in establishment and verification of sensitivity of nucleic acid detection and analysis

作　　者：李海梅 林丹英 罗必泰 LI Haimei;LIN Danying;LUO Bitai(Department of Clinical Laboratory,Nanning Blood Center,Guangxi,Nanning 530007,China)

机构地区：[1]南宁中心血站检验科,广西南宁530007

出　　处：《中国医药科学》2023年第13期145-148,共4页China Medicine And Pharmacy

摘　　要：目的在核酸检测系统正式投入使用前,通过检测商品化核酸系列分析灵敏度血清盘,应用机率单位加权回归法(Bliss法)计算核酸检测系统的分析灵敏度,验证检测系统在实际使用中的检测性能与厂商声明的一致性,确保核酸检测质量。方法使用新购进的基立福(GRIFOLS)全自动核酸检测系统对商品化核酸系列分析灵敏度血清盘全部样本进行单人份检测,应用Bliss法进行概率单位(Porbit)回归分析,分别计算乙型肝炎病毒(HBV)、丙型肝炎病毒(HCV)、人类免疫缺陷病毒1型(HIV-1)三个项目的95%检出限,并比较其与厂商声明的一致性。结果GRIFOLS全自动核酸检测系统HBV、HCV、HIV-1三个项目的分析灵敏度分别为3.97、2.12、11.60 IU/ml,均优于厂商声明的分析灵敏度。结论Bliss法能够应用于核酸检测分析灵敏度的计算,了解核酸检测系统的实际最低检出能力,直观判断核酸检测系统分析灵敏度是否达到预期要求。Objective To test the serum plates for sensitivity analysis of nucleic acid series,calculate the analytical sensitivity of the nucleic acid detection system by using probit weighted regression method(Bliss method),and verify the consistency between the detection performance of the detection system in actual use and the manufacturer’s statement before the nucleic acid detection system is officially put into use,so as to ensure the quality of nucleic acid detection.Methods The newly purchased GRIFOLS automatic nucleic acid detection system was used to detect all samples of serum plates for sensitivity analysis of nucleic acid series analytical sensitivity serum tray in one copy,and the probability unit(Porbit)regression analysis was performed by Bliss method.The 95%detection limits of hepatitis B virus(HBV),hepatitis C virus(HCV)and human immunodeficiency virus type 1(HIV-1)were calculated respectively,and compared with the manufacturer’s statement.Results The analytical sensitivities of GRIFOLS automatic nucleic acid detection system for HBV,HCV and HIV-1 were 3.97,2.12 and 11.60 IU/ml,respectively,which were all better than those declared by the manufacturer.Conclusion Bliss method can be applied to calculate the sensitivity of nucleic acid detection and analysis,understand the actual minimum detection ability of nucleic acid detection system,and intuitively judge whether the analysis sensitivity of nucleic acid detection system meets the expected requirements.

关 键 词：Bliss法 核酸检测 灵敏度 血清盘 95%检出限 

分 类 号：R440[医药卫生—诊断学]