摘要
目的制备人高尔基体蛋白73(GP73)免疫放射分析(IRMA)和化学发光免疫分析(CLIA)试剂盒,探讨两者在原发性肝癌及肝硬化中的诊断价值。方法将一株GP73单抗连接到羧基磁微粒表面作为固相载体,另一株单抗分别用125I及吖啶酯标记作为示踪剂,研制GP73 IRMA和CLIA试剂盒,对其灵敏度、精密度和回收率等指标进行分析。应用这2种试剂盒检测临床血清样本,评价其对正常健康者(正常组:n=60)、原发性肝癌患者(原发肝癌组:n=52)、肝硬化患者(肝硬化组:n=51)的诊断价值。组间的比较采用独立样本t检验。结果IRMA和CLIA试剂盒对GP73的分析灵敏度分别为0.91、0.32 ng/ml。IRMA和CLIA试剂盒的批内变异性分别为4.26%、3.52%,批间变异性分别为6.84%、6.38%。IRMA和CLIA试剂盒的平均回收率分别为98.21%、98.69%。IRMA和CLIA试剂盒对肝硬化组的测定均值分别为80.85、82.73 ng/ml;原发性肝癌组的测定均值分别为219.34、226.31 ng/ml,而正常组的测定均值分别为11.23、11.68 ng/ml。前2组与正常组相比,差异均有统计学意义(t=-11.765~-11.539,均P<0.05)。结论本研究制备的GP73 IRMA和CLIA试剂盒各项技术指标良好,可用于原发性肝癌及肝硬化疾病的筛查以及临床辅助诊断。
Objective To prepare human Golgi protein 73(GP73)immunoradiometric assay(IRMA)and chemiluminescence immunoassay(CLIA)kits and explore their value in the diagnosis of primary liver cancer and liver cirrhosis.Methods One monoclonal antibody against GP73 was linked to the surface of carboxyl magnetic microparticles as a solid-phase carrier,and another was labeled with 125I and acridinium ester as tracers to develop the GP73 IRMA and CLIA kits.The sensitivity,precision,and recovery rate of the kits were analyzed.Their diagnostic value for normal healthy individuals(normal group:n=60),patients with primary liver cancer(primary liver cancer group:n=52),and patients with liver cirrhosis(liver cirrhosis group:n=51)was evaluated by applying them to detect clinical serum samples.Intergroup comparisons were made using independent sample ttests.Results The analytical sensitivity of IRMA and CLIA kits for GP73 was 0.91 and 0.32 ng/ml,respectively.The intrabatch variability of the IRMA and CLIA kits was 4.26%and 3.52%,respectively,and the interbatch variability was 6.84%and 6.38%,respectively.The average recovery rate of the IRMA and CLIA kits was 98.21%and 98.69%,respectively.The measured mean value of the IRMA and CLIA kits was 80.85 and 82.73 ng/ml for the liver cirrhosis group,respectively,219.34 and 226.31 ng/ml for the primary liver cancer group,respectively,and 11.23 and 11.68 ng/ml for the normal group.Relative to the normal group,the differences for the first two groups were statistically significant(t=−11.765 to−11.539,all P<0.05).Conclusion The GP73 IRMA and CLIA kits prepared in this study have good technical indicators and can be used for the screening and clinical auxiliary diagnosis of primary liver cancer and liver cirrhosis.
作者
杨思思
范文红
谌红彬
郑娜
王立凯
Yang Sisi;Fan Wenhong;Chen Hongbin;Zheng Na;Wang Likai(Key Laboratory of Clinical Immunoassay Technology for Tianjin's Companies,Union Medical and Pharmaceutical Technology(Tianjin)Group Ltd.,Tianjin 300301,China;Department of Equipment,Tianjin Medical University General Hospital,Tianjin 300052,China)
出处
《国际放射医学核医学杂志》
2024年第7期429-434,共6页
International Journal of Radiation Medicine and Nuclear Medicine
