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目的探讨酶联免疫吸附试验(ELISA)检测血清甲胎蛋白异质体(AFP-L3)含量对原发性肝癌(PLC)的诊断价值。方法选择2011年3月-11月门诊或住院的137例患者临床检测甲胎蛋白(AFP)为阳性的肝病患者血清,应用上海逸峰生物科技有限公司提供的ELISA法AFP-L3检测试剂盒检测AFP-L3浓度,137例中男98例,女39例,年龄28～77岁。其中PLC 92例,良性肝病45例,后者包括肝硬化37例、慢性肝炎8例。分析PLC组与良性肝病组AFP-L3浓度差异,运用受试者工作特征曲线(ROC)分析AFP-L3含量在PLC鉴别诊断中的价值。结果 PLC组AFP-L3浓度[(109.04±62.51)ng/mL]明显高于良性肝病组[(25.96±49.43)ng/mL,两组差异有统计学意义(t=8.28,P<0.001)。ROC分析结果显示,曲线下面积为0.819,以AFP-L3浓度37.89 ng/mL为临界值,分析92例PLC患者与45例良性肝病患者AFP-L3浓度异常的灵敏度为83.69%,特异度为88.88%,阳性预测值为93.90%(77/82),阴性预测值为72.72%(40/55),诊断准确度为85.40%。结论应用简便快速的ELISA法检测AFP-L3浓度在PLC与良性肝病鉴别诊断中具有较高的临床价值,便于临床推广。
Objective To investigate the diagnostic value of serum AFP-L3 in primary hepatocellular carcinoma (PLC) by enzyme linked immunosorbent assay (ELISA). Methods A total of 137 outpatients or hospitalized patients with serum AFP positive sera from March to November in 2011 were selected and tested by AFP-L3 ELISA kit provided by Shanghai Yifeng Biotechnology Co., Ltd. AFP-L3 concentration, 137 cases of male 98 cases, 39 females, aged 28 to 77 years. Of which 92 cases of PLC, 45 cases of benign liver disease, which includes 37 cases of cirrhosis, 8 cases of chronic hepatitis. The difference of AFP-L3 concentration between PLC group and benign liver disease group was analyzed. The value of AFP-L3 content in differential diagnosis of PLC was analyzed by receiver operating characteristic curve (ROC). Results The AFP-L3 concentration of (109.04 ± 62.51) ng / mL in PLC group was significantly higher than that in benign liver disease group [(25.96 ± 49.43) ng / mL, t = 8.28, P <0.001. The ROC analysis showed that the area under the curve was 0.819. The AFP-L3 concentration of 37.89 ng / mL was the critical value. The sensitivity and specificity of AFP-L3 concentration in 92 patients with PLC and 45 patients with benign liver disease were 83.69% and 88.88 %, The positive predictive value was 93.90% (77/82), the negative predictive value was 72.72% (40/55), and the diagnostic accuracy was 85.40%. Conclusion The simple and rapid ELISA method for the determination of AFP-L3 concentration in the differential diagnosis of PLC and benign liver disease has a high clinical value, ease of clinical promotion.