摘要
目的 初步评价单克隆抗体免疫比浊法（MAITA）检测血清血管生成素-2（Ang-2）试剂盒,探讨Ang-2在肺癌患者血清中的表达及临床意义.方法 采用CLSI EP10-A2实验方案初步评价MAITA检测血清Ang-2的精密度、偏差、线性漂移、交叉污染等性能;测定153例健康者血清Ang-2水平建立参考值范围;测定156例（包括68例肺癌）患者的血清Ang-2和硫酸粘多糖片段（SGF）水平,应用受试者工作特征曲线（ROC）评估Ang-2在肺癌患者的应用价值.结果 三个异值样本的总不精密度和偏差中,低值拒绝,中、高值均可接受;截距、斜率和非线性差异均有显著性.Ang-2的参考值范围：（17.29±5.05）U/ml;肺癌的最佳诊断界限值为37.50 U/ml.肺癌患者血清Ang-2（48.34±15.29）U/ml明显高于肺部良性疾病患者和健康组[分别为（24.67±5.53）U/ml和（19.93±5.92）U/ml,P〈0.01].Ang-2与SGF联合检测肺癌患者的阳性率达95.59%.结论 MAITA检测血清Ang-2试剂盒符合CLSI EP10-A2文件要求,Ang-2在各期肺癌患者血清中有较高表达,与SGF联合检测可有效提高对肺癌的诊断.
Objective To evaluate monoclonal antibody transmission immunoturbidimetric asccccsay （ MAITA ） for detecting serum angiopoietin-2 （ ang-2 ）, and to explore ang-2 in patients with lung cancer and its clinical significance. Methods The precision, bias, linear drift, and cross-contamination performance of serum ang-2 detected by MAITA were evaluated with clinical and laboratory standards institue （ CLSI ）, EP10-A2 experiment scheme; Serum ang-2 and sulfate glycosaminoglycan fragments （ SGF ） were detected in 153 healthy people for the establishment of reference values; Serum ang-2 was detected in 156 patients （ 68 with lung cancer ） to assess the diagnostic performance in lung cancer patients using receiver operating characteristic curve （ ROC ）. Results The total imprecision and the bias of the three different samples, low rejection, and middle and high values were acceptable. There was a significant difference in intercept, slope and non-linear. Ang-2 in the reference range was （ 17.29 ± 5.05 ）U/ml. The best d
出处
《国际医药卫生导报》
2010年第21期2574-2577,共4页
International Medicine and Health Guidance News
基金
肇庆市科技创新计划项目（2008E383）
关键词
单克隆抗体
免疫比浊
血管生成素-2
肺癌
Monoclonal antibody
Immunoturbidimetric assay
Angiopoietin-2
Lung cancer
