中国免疫学杂志Issue(8)：1093-1097,5.DOI:10.3969/j.issn.1000-484X.2014.08.019
时间分辨荧光免疫分析法检测心肌肌钙蛋白Ⅰ方法学的建立及临床应用
Development of a time-resolved fluorescence immunoassay for rapid determinat-ion of levels of cardiac troponin Ⅰantigen in human serum
摘要
Abstract
To establish a method to detect cardiac troponin I by using time-resolved fluoroimmunoassay ( TRFIA) and apply to the clinic.Methods:The assay were measured by TRIFA and double antibody sandwich method .Standard protocols were evaluated with the standard curve , the limit of detection , stability, precision and cross reaction .Healthy reference populations and clinical serum specimens were measured to established the reference interval and evaluated the perspective of the clinical application . Results:The standard curve was Y=7485 .878+1400.924 X with a correlation coefficient of 0.999.The limit of detection was 0.052 ng/ml.The intra-and inter-assay coefficients of variation ( CV) were all <10%.Reference values was <0.14 μg/L.The AUC of ROC curve was 0.971 while the sensitivity was 96.45%,the specificity was 91.43% and the accuracy was 95.69%, with 98.45% of positive predictive value and 82.05%of negative predictive value.The correlation coefficient was 0.993 between our proposed method and the commercially available CLIA kits.There was no significant difference in statistics compared with ECG , CK-MB and cTnT ( P>0.05 ).There was significant difference in statistics compared before and after treatment with AMI ( P<0.001 ) .Conclusion: The TRFIA method for detecting cTnI achieves clinical application standards and may be used for the diagnosis and serosurveillance of acute myocardial infarction patients.关键词
时间分辨荧光免疫分析/心肌梗死/肌钙蛋白Ⅰ/分析性能/Eu3+Key words
Time-resolved fluorescence immunoassay/Myocardial infarction/cTnI/Analytical performance/Eu3+分类
医药卫生引用本文复制引用
张洁,卢玲玲,潘晓夫,邹立林,高基民..时间分辨荧光免疫分析法检测心肌肌钙蛋白Ⅰ方法学的建立及临床应用[J].中国免疫学杂志,2014,(8):1093-1097,5.基金项目
浙江省医药卫生科学研究基金项目（No畅2005A084）。 （）
