均相化学发光免疫分析技术定量检测NT-proBNP方法的建立

Establishment of quantitative detection method of NT proBNP by homogeneous chemiluminescence immunoassa

目的建立一种基于均相化学发光免疫分析技术定量检测血清N-末端脑钠肽前体(NT-proBNP)的方法。方法以生物素化的NT-proBNP单克隆抗体1、包被有NT-proBNP单克隆抗体2的受氧微球和包被有链霉亲和素的供氧微球作为检测试剂,实现对NT-proBNP含量的检测,并对该方法的灵敏度、线性范围、精密度、准确度进行初步评价。结果均相化学发光免疫分析技术可以用于检测NT-proBNP含量,其分析灵敏度为:10 pg/mL,检测范围为:20.0~30000.0 pg/mL,批内及日间变异系数均小于10.0%。本方法与罗氏电化学发光检测试剂盒平行检测55例临床样本,两者的相关系数达0.99。结论均相化学发光免疫分析技术定量检测血清NT-proBNP检测方法的建立为临床应用提供了参考依据。

Objective To establish a method for quantitative detection of serum NT-proBNP based on homogeneous chemiluminescence immunoassay technology.Methods Detected the content of NT-proBNP,biotinylated NT-proBNP monoclonal antibody 1,acceptor beads coated with NT-proBNP monoclonal antibody 2,and donor beads coated with streptavidin were used as detection reagents and the sensitivity,linear range,precision and accuracy of the method were preliminary evaluation.Results The homogeneous chemiluminescence immunoassay technology could detect NT-proBNP content with an analytical sensitivity of 10 pg/mL and a detection range of 20.0 pg/mL-30000.0 pg/mL.The intra-and inter-day coefficients of variation are less than 10.00%.This method was used to test 55 cases of clinical samples in parallel with roche electrochemical luminescence detection kit and the correlation coefficient between the two was 0.99.Conclusion The establishment of quantitative detection of serum NT-proBNP by homogeneous chemiluminescence immunoassay technology may provide a reference for clinical application.