血浆肝素结合蛋白免疫荧光干式定量检测试剂盒的性能评价  

Performance Evaluation of Plasma Heparin Binding Protein Immunofluorescence Dry Determination Kit

作　　者：王杜平[1] WANG Du-ping(Department of Clinical Laboratory,Xuzhou Central Hospital,Xuzhou,Jiangsu,221009,China)

机构地区：[1]徐州市中心医院检验科,江苏徐州221009

出　　处：《中国血液流变学杂志》2020年第2期231-233,共3页Chinese Journal of Hemorheology

摘　　要：目的 验证免疫法测定血浆肝素结合蛋白(HBP)的方法学性能.方法 采用中翰盛泰生物技术有限公司生产的免疫荧光干式定量试剂盒检测HBP,选用企业内部标准物质、质控品和健康人群血浆样本,验证该检测方法的正确度、精密度、线性和参考值区间,评价其方法学性能.结果 免疫层析法测定HBP低(5.9 ng/mL)、高(275.0 ng/mL)浓度标准品的相对偏倚分别为4.40%、2.95%,正确度试验结果良好;简易精密度试验,HBP低(18.4 ng/mL)、高(192 ng/mL)二个浓度标本的变异系数(CV)分别为7.68%、5.44%,精密度符合厂商标准要求(CV不大于10%);采用校准品进行线性试验,当HBP浓度范围在275 ng/mL内时,线性回归方程Y=0.9141X+0.9922,R2=0.998;参考区间评价,所选40名健康体检者血浆样本测得值均在标定的参考值(<11.40 ng/mL)范围内;以上项目的评价结果均达到厂商说明的标准.结论 免疫荧光干式定量法检测HBP快捷、准确、方便,可用于临床检测.Objective To verify the methodological performance of immunoassay for the determination of plasma heparin-binding protein(HBP).Methods Immunofluorescence dry determination kit produced by Zhonghan Shengtai Biotechnology Co.,Ltd.was used to detect the internal standard materials,quality control products and plasma samples of healthy population.Results The relative bias of low HBP(5.9 ng/mL)and high(275.0 ng/mL)concentrations was 4.40%and 2.95%,respectively,and the accuracy was good.The coefficient of variation(CV)of low HBP(18.4 ng/mL)and high(192 ng/mL)were 7.68%and 5.44%.The linear regression equation was Y=0.9141X+0.9922,R^2=0.99&when the HBP concentration range was within 275 ng/mL;Reference interval evaluation showed that the measured values of plasma samples of 40 healthy subjects were within the range of the reference values(<11.40 ng/mL).Conclusion Immunofluorescence dry quantitative method for detecting HBP is rapid,accurate and convenient,and can be used for clinical detection.

关 键 词：肝素结合蛋白 免疫荧光干式定量技术 性能验证 

分 类 号：R446.1[医药卫生—诊断学]