两种国产化学发光测试系统测定乙型肝炎病毒表面抗体的一致性评价  

The Consistency Evaluation of Two Domestic Chemiluminescence Testing Systems for the Determination of Hepatitis B Virus Surface Antibodies

作　　者：曹春玲 张润锋 严诗云 潘晓芳[1] 吴静标[1] Cao Chunling;Zhang Runfeng;Yan Shiyun;Pan Xiaofang;Wu Jingbiao(Guangdong Medical Devices Quality Surveillance and Test Institute,Guangzhou Guangdong 510663,China)

机构地区：[1]广东省医疗器械质量监督检验所,广东广州510663

出　　处：《医疗装备》2023年第23期27-30,共4页Medical Equipment

基　　金：广州市科创委项目(2020B0404010002)。

摘　　要：目的比较2种不同国产化学发光测试系统(测试系统1和测试系统2)测定乙型肝炎病毒表面抗体(HBsAb)检测结果间的统计学关系和线性关系,探讨不同测试系统检测结果的一致性。方法选取6~100 mIU/ml系列浓度样本,分别使用2个国产化学发光法测试系统(测试系统1和测试系统2)和临床使用广泛的测试系统A进行检测。将测试系统1和测试系统2的结果分别与测试系统A的结果采用加权最小二乘法进行直线拟合计算相关系数;并以测试系统1和测试系统2的结果均值和信号值均值作为变量,使用配对t检验进行统计学分析;以测试系统A的结果为自变量,以测试系统1和测试系统2的结果为因变量进行线性拟合,分别计算相关系数r、绝对线性偏差和相对线性偏差。结果测试系统1和测试系统2中HBsAb定量检测结果比较,差异有统计学意义[υ=8,ABS(t)=2.535,t0.05(8)=2.306,P<0.05];测试系统1和测试系统2测试浓度间的线性相关性拟合相关系数r=0.99341。测试系统1与测试系统A的相关系数r=0.99814。测试系统2与测试系统A的相关系数r=0.98821。结论2个国产测试系统的检测结果具有良好的可比性,且与临床使用广泛的测试系统A的检测结果一致性较好,临床可根据检验室检验需求选择合适的测试系统。Objective To compare the statistical and linear relationships between the detection results of hepatitis B virus surface antibody(HBsAb)by using two different domestically produced chemiluminescence testing systems(Test System 1 and Test System 2),and to explore the consistency of the detection results of different testing systems.Methods With use of a series of concentration samples ranging from 6 to 100 mIU/ml,two domestically produced chemiluminescence testing systems(Test System 1 and Test System 2)and the System A widely used in clinical test were used for testing,respectively.The weighted least squares method was used to fit the results of Test System 1 and Test System 2 with the results of Test System A in a straight line to calculate the correlation coefficient.In addition,with the mean of the results and signal values of Test System 1 and Test System 2 as variables,the paired t-test was used for statistical analysis.With the use of the results of test system A as the independent variable and test systems 1 and 2 as the dependent variables,linear fitting was performed,and the correlation coefficient r,absolute linear deviation,and relative linear deviation were calculated separately.Results There was a statistically significant difference in the quantitative detection results of HBsAb between Test System 1 and Test System 2[υ=8,ABS(t)=2.535,t 0.05(8)=2.306,P<0.05];The linear correlation fitting correlation coefficient r=0.99341 between the test concentrations of test system 1 and test system 2.The correlation coefficient r=0.99814 between test system 1 and test system A.The correlation coefficient r=0.98821 between test system 2 and test system A.Conclusion With the good comparability for the test results of two domestic testing systems,and good consistency with the test results of widely used testing system A in clinical practice,the testing system can be selected according to the testing needs of the laboratory,In clinical applications.

关 键 词：乙型肝炎病毒表面抗体 化学发光法 一致性 

分 类 号：R373.2[医药卫生—病原生物学]