NMBS-TRFIA法检测血清S100A11对胰腺癌的诊断价值

摘要

目的 通过建立纳米磁珠分选联合时间分辨免疫荧光测定(nanomagicbeabs sorting-time resolved fluoroimmuno assay,NMBS-TRFIA)检测血清钙囊素(S100A11)的水平,同时评价其对胰腺癌的诊断价值.方法 选择88例胰腺癌、50例急性胰腺炎、10例胰腺囊肿患者和20例健康体检者作为研究对象.先采用S100A11抗体耦联的纳米磁珠对人外周血清进行分选,再用TRFIA法检测S100A11浓度.应用受试者工作特征(ROC)曲线下面积(AUC)确定诊断胰腺癌的界值,以评价诊断胰腺癌的敏感度和特异度.结果 NMBS-TRFIA法检测S100A11在6.08～500 ng/ml范围内呈线性关系,批内Cv≤6.35％,批间CV≤7.12％,平均回收率为104.7％.胰腺癌、急性胰腺炎和胰腺囊肿患者血清S100A11水平分别为185.53±161.19,106.06±113.83和68.99±47.83 ng/ml,与正常对照组(37.98±25.14 ng/ml)比较,差异均有统计学意义(t=-8.065,-3.375,-2.266,均P＜0.01);胰腺癌患者明显高于急性胰腺炎、胰腺囊肿患者(均P＜0.05).根据ROC曲线,ROCAUC=0.985(95％ CI:0.972～0.997),诊断胰腺癌的最佳界值为89.5 ng/ml(敏感度81.8％,特异度67.5％).结论 NMBS-TRFIA法可富集血清中S100A11,提高血清S100A11检出敏感度,且操作方法简便、易于推广.血清S100A11诊断胰腺癌具有较高的敏感度和特异度,是一种诊断早期胰腺癌的新型血清标志物.%Objective To detect the serum levels of calpainin (S100A11) using nanomagicbeabs sorting-time resolved fluoroimmuno assay (NMBS-TRFIA) and evaluate its diagnostic value in pancreatic carcinoma.Methods 88 patients with pancreatic carcinoma,50 patients with acute pancreatitis,10 patients with pancreatic cyst and 20 healthy controls were selected as the study subjects.The human peripheral serum blood was sorted with S100A11 antibody coupled nanomagicbeabs,and the concentration of S100A11 was detected by TRFIA method.The area under the receiver operating characteristic (ROC) curve (AUC) was used to determine the cut-off level for diagnosis of pancreatic carcinoma,in order to evaluate the sensitivity and specificity for diagnosis of pancreatic carcinoma.Results S100A11 showed a linear relationship within the range of 6.08～ 500 ng/ml using NMBS-TRFIA method,intraassay CV≤6.35％,inter-assay CV≤7.12％,and the average recovery rate was 104.7％.The serum levels of S100A11 in patients with pancreatic carcinoma,patients with acute pancreatitis and patients with pancreatic cyst were 185.53 ± 161.19,106.06±113.83 and 68.99± 47.83 ng/ml respectively.Compared with the normal control group (37.98±25.14 ng/ml),the differences were statistically significant (t=-8.065,-3.375,-2.266,all P ＜0.01).The serum levels of S100A11 in patients with pancreatic carcinoma was significantly higher than those in patients with acute pancreatitis and patients with pancreatic cyst (all P＜0.05).According to the ROC curve,ROCAUC=0.985 (95％ CI:0.972 ～ 0.997),the best cut-off level for the diagnosis of pancreatic carcinoma was 89.5 ng/ml (sensitivity 81.8 ％,specificity 67.5 ％).Conclusion NMBS-TRFIA can enrich S100A11 in serum and improve the detection sensitivity of serum S100A11,and the method is simple and easy to be popularized.Serum S100A11 has a high sensitivity and specificity in the diagnosis of pancreatic carcinoma,and is a new serum marker for the diagnosis of early pancreatic carcinoma.