癌胚抗原蛋白芯片的研发及其在肝癌检测中的评价

目的:研究建立一种简便、快速、特异性高、低成本的检测血清中癌胚抗原(CEA)浓度的蛋白芯片,并通过检测肝细胞肝癌(HCC)对其进行评价。方法:采用双抗体夹心法,制备能够形成捕获抗体-抗原-检测抗体的"三明治"结构的蛋白芯片检测血清中CEA浓度。通过用该蛋白芯片检测50例CEA阳性HCC患者血清和56例健康人血清,对其进行盲法验证。结果:以CEA5 ng/m L为阳性判定标准,得出CEA蛋白芯片的灵敏度为92%(46/50),特异度为100%(56/56)。受试者工作特征(ROC)曲线分析显示该蛋白芯片检测出血清CEA的ROC曲线下面积(AUC)为0.960,与0.5相比差异有统计学意义(P0.001),其判定CEA阳性的准确性较高。结论:成功建立检测血清中CEA浓度的蛋白芯片,为下一步研发多种标志物联合检测HCC的蛋白芯片提供候选血清标志物。

Study of Carcinoembryonic Antigen Protein Microarray Testing in Hepatocellular Carcinoma

Objective:To develop a simple, rapid, highly specific, and low-cost protein microarray for detecting carcinoembryonic antigen (CEA) levels in serum, and to evaluate it through diagnosis of of hepatocellular carcinoma (HCC).Methods:Using double-antibody sandwich method, the protein microarray were prepared with"sandwich" structure of capture antibody-antigen-detection antibody to detect CEA levels in serum. In the blind experiment, 50 CEA positive serum samples from patients with HCC and 56 serum samples from healthy human were detected by the CEA protein microarray.Results:CEA> 5 ng/mL was as positive criteria, the sensitivity of CEA protein chip was 92 %(46/50) , and its specificity was 100 % (56/56). Receiver operating characteristic curve (ROC) analysis showed that area under the ROC curve (AUC) of serumCEA detection by the protein microarray was 0.960, and comparing with the 0.5 the result was statistically significant (P <0.001), and its diagnostic accuracy for CEA was high.Conclusion:The protein microarray for detecting CEA concentration in serum was successfully established, and provided one candidate biomarker to develop multiple biomarkers protein chips for combination detection of HCC.