【摘要】 目的:建立以椭偏光生物传感器为基础的光学蛋白芯片(OPC-IE)定量检测CA15-3抗原方法。方法:探索OPC-IE生物分子芯片系统检测CA15-3抗原方法及建立了CA15-3抗原浓度-灰度检测标准曲线,依据标准曲线定量检测了80份血清(对照组及癌症患者组)样本,并将检测结果与电化学发光法(ECLIA)进行比较。结果:所建立的OPC-IE检测CA15-3方法,在46.33、23.16和11.58 IU/mL的组间变异系数(n=6)分别为7.67%、10.57%和9.40%,试验结果有良好重复性。浓度-灰度标准曲线的R2=0.97,检测最小值为5.30 IU/mL。对照组CA15-3抗原浓度为(2.84±0.73)IU/mL,癌症患者组为(52.45±7.50)IU/mL,两组浓度差异有统计学意义,P<0.05。ROC曲线和t检验分析80份血清OPC-IE和ECLIA检测结果,显示差异无统计学意义,P>0.05。结论:初步建立了OPC-IE CA15-3抗原检测方法,并且成功的应用于血清检测。更多还原

【Abstract】 OBJECTIVE:To investigate the feasibility of optical proteinchip based on imaging ellipsometry biosensor(OPC-IE) applying to CA15-3 antigen assay.METHODS: The technological method for detecting CA15-3 antigen by OPC-IE and its concentration-gray standard curve were established,then 80 serum samples from both normal and cancer patients were examined.The detection results of CA15-3 antigen were compared with detections by electrochemistry luminescence method(ECLIA).RESULTS: Our method for detecting CA15-3 antigen showed a good repeatability,the coefficient of variation values were 7.67%,10.57% and 9.40% at 46.33,23.16 and 11.58 IU/mL,respectively(n=6).Pearson correlation coefficient(R2) of concentration-gray scale standard curve was 0.97,and the lowest detectable limit of standard curve was 5.30 IU/mL.Concentrations of CA15-3 antigen were differed significantly in normal(2.84±0.73) IU/mL and cancer patients(52.45±7.50) IU/mL(P<0.05),There was no significant difference between the detections by OPC-IE and ECLIA(P>0.05).CONCLUSION: A method for detecting CA15-3 antigen was established and it was tested in clinical serum examination.更多还原