心肌肌钙蛋白I(cTnI)荧光免疫层析试剂研究

Research on Cardiac Troponin I(cTnI)Fluorescence Immunochromatography Reagent

本文通过分析建立的心肌肌钙蛋白I检测试剂(荧光免疫层析法)的性能,确定该试剂应用于临床早期诊断心肌损伤中的应用价值,并考察了检测试剂的准确性、分析灵敏度、精密性、特异性、抗干扰能力及线性范围,同时与上市的产品进行性能比对。结果表明:准确性回收率在85%~115%;批内变异系数CV不高于15%;心肌肌钙蛋白T(cTnT)、心肌肌钙蛋白C(cTnC)、骨骼肌型肌钙蛋白I(sTnI)在1000 ng/mL浓度条件下,未出现非特异反应现象;胆红素350μmol/L、甘油三酯40 mmol/L、血红蛋白2 g/L、类风湿因子1500 IU/mL,未影响样本检测结果,且试剂盒的线性范围为0.1~50.0 ng/mL;肝素钠抗凝血浆、EDTA-K2抗凝血浆、枸橼酸钠抗凝血浆(抗凝剂∶样本=1∶9)、血清样本及红细胞压积在30%~50%全血样本范围内均可作为检测样本。检测血清104例样本,与已批准上市、临床普遍认为质量较好的产品的检测结果无统计学差异,并且具有高度一致性。

By analyzing the performance of the established cardiac troponin I(cTnI)detection reagent(fluorescence immunochromatography),the application value of the reagent in the early clinical diagnosis of myocardial injury was determined,and the accuracy,analytical sensitivity,precision,specificity,anti-interference ability,linear range of the detection reagent were investigated,and the performance was compared with the products on the market in this paper.The results showed that the accuracy rate was 85%~115%.The intra-assay coefficient of variation was not higher than 15%.Cardiac troponin T(cTnT),cardiac troponin C(cTnC),and skeletal troponin I(sTnI)showed no nonspecific reaction at the concentration of 1000 ng/mL.350μmol/L bilirubin,40 mmol/L triglyceride,2 g/L hemoglobin,1500 IU/mL rheumatoid factor did not affect the test results of the sample,and the linear range of the kit was 0.1~50.0 ng/mL.Heparin sodium anticoagulated plasma,EDTA-K2 anticoagulated plasma,sodium citrate anticoagulated plasma(the ratio of anticoagulant and sample is 1 to 9),serum samples and whole blood with hematocrit of 30%~50%can be used as a test samples.104 serum samples were tested,which have been approved for marketing and clinically generally believed that there is no statistical difference in the test results of high-quality products,and there is a high degree of consistency.