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目的 采用纳米磁珠分选联合时间分解荧光免疫测定(纳米磁珠-TRFIA)的方法检测血清半乳糖凝集素-3(Galectin-3)的浓度,评价其对胰腺癌的诊断价值.方法 收集88例胰腺癌、50例急性胰腺炎、10例胰腺囊肿患者的血清,以20位健康者作为正常对照组.先采用Galectin-3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Galectin-3浓度,并与常规TRFIA法检测所得的血清Galectin-3浓度进行比较.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,获取诊断胰腺癌的敏感性.结果 纳米磁珠-TRFIA法检测Galectin-3浓度在0.78 ～ 100 ng/ml范围内呈线性关系,批内CV≤6.38％,批间CV≤7.22％,平均回收率为105.3％.纳米磁珠-TRFIA法检测正常对照组的血清Galectin-3浓度为0.38(0.02～3.06) ng/ml,显著高于常规TRFIA法检测得到的0.18(0.00～2.64) ng/ml(P=0.000).纳米磁珠-TRFIA法检测的胰腺癌、急性胰腺炎、胰腺囊肿患者血清Galectin-3浓度分别为4.85(0.00 ～42.67)、0.69(0.00～ 13.62)、0.70(0.00 ～ 14.54) ng/ml,胰腺癌患者明显高于急性胰腺炎、胰腺囊肿患者及正常对照者(P值均＜0.01),而其他3组之间的浓度差异无统计学意义.Galectin-3诊断胰腺癌的AUC为0.851 ±0.040,95％可信区间0.772 ～ 0.929.以Galectin-3浓度1.07 ng/ml为诊断界值时,胰腺癌、急性胰腺炎、胰腺囊肿患者及正常对照者的阳性率分别为84.1％(74/88)、34.0％ (17/50)、20.0％ (2/10)、10.0％ (2/20),对胰腺癌的诊断敏感性显著高于其他3组(P值均＜0.01).结论 纳米磁珠分选联合TRFIA法可富集血清中的Galectin-3,从而提高血清Galectin-3检出敏感性及其对胰腺癌的诊断价值.“,”Objective To study the value of serum galectin-3 detected by nanomagnetic beads sorting time resolved fluoroimmunoassay (TRFIA) tandem analysis in the diagnosis of pancreatic cancer.Methods The serum of 88 cases of pancreatic cancer,50 cases of acute pancreatitis,10 cases of pancreatic cysts,and 20 cases of healthy volunteers as control were collected.First,galectin-3 antibody coupled nanomagnetic-beads was used to sort the semm,then TRFIA was applied to detect the level of galectin 3,and the result was compared with that of routine TRFIA.ROC curve was constructed to determine the cutoff value and sensitivity for pancreatic cancer diagnosis.Results The method of nanomagnetic beads sorting TRFIA detected the level of galectin 3 between O.78 and 100 ng/ml in a linear manner,the intra-CV was ≤6.38％,and inter-CV was ≤7.22％,and average recovery rate was 105.3％.The serum level of galectin-3 in control group by nanomagnetic beads sorting TRFIA was 0.38 (0.02 ～ 3.06) ng/ml,which was significantly higher than that detected by routine TRFIA [0.18 (0.00 ～ 2.64) ng/ml,P =0.000).The serum levels of galectin-3 by nanomagnetic beads sorting TRFIA in pancreatic cancer,acute pancreatitis,pancreatic cysts and healthy volunteers were 4.85(0.00 ～42.67),0.69(0.00～ 13.62),0.70(0.00 ～ 14.54),0.38(0.02 ～ 3.06) ng/ml,and the level of galectin-3 in pancreatic cancer was significantly higher than that in acute pancreatitis,pancreatic cysts and healthy volunteers group (P ＜0.01),while the difference among the other three group was not significantly different.The AUC of galectin-3 for pancreatic cancer was 0.851 ± 0.040,95％ CI:0.772 ～ 0.929.While using 1.07 ng/ml as the cut-off value,the positive rates for the diagnosis of pancreatic cancer,acute pancreatitis,pancreatic cysts and healthy volunteers were 84.1％ (74/88),34.0％ (17/50),20.0％ (2/10),10.0％ (2/20),and the sensitivity for diagnosis of pancreatic cancer was significantly higher than those in other 3 groups (P ＜ 0.01).Conclusions Nanomagnetic beads sorting TRFIA tandem analysis method can enrich serum galectin-3,and increase the sensitivity of detection for pancreatic cancer and enhance the diagnostic value of galectin-3 for pancreatic cancer.