化学发光酶免疫法检测血清GP73的临床应用

Chemiluminescence immunoassay for Golgi protein 73 in human serum and its clinical application

目的利用新研发的磁颗粒化学发光法(magnetism particulate chemiluminescence immunoassay,MP-CLIA)替代酶联免疫法(enzyme linked immunosorbent assay,ELISA)检测肝细胞癌(hepatocellular carcinoma,HCC)、肝硬化、病毒性肝炎、自身免疫性肝炎等多种临床样本的血清高尔基体蛋白73(Golgi protein 73,GP73)浓度,进一步探讨MP-CLIA检测血清GP73的临床应用价值。方法采用建立的MP-CLIA法分别检测健康对照者及各种病人血清GP73浓度,并进行分组比较分析。分别计算MP-CLIA和ELISA 2种方法检测GP73诊断HCC的受试者工作特征(receiver operating characteristic,ROC)曲线下面积。测定50例肝硬化病人和69例HCC病人血清GP73和甲胎蛋白(alpha-fetoprotein,AFP)浓度,比较GP73和AFP对HCC的临床诊断效能。同时,对69例HCC病人进行分期比较GP73浓度,对其他良性肝病和其他肿瘤组分别与健康对照组比较分析血清GP73浓度。结果MP-CLIA与ELISA两种方法测定血清GP73在HCC诊断中的ROC曲线下面积差异无统计学意义(P>0.05)。肝细胞癌组、肝硬化组和健康对照组的血清GP73浓度差异有统计学意义(P<0.05)。肝细胞癌中T1期、T2期、T3期和T4期的血清GP73浓度分别为1.88 nmol/L,2.72 nmol/L,3.22 nmol/L和3.44 nmol/L,早期HCC组与肝硬化组和晚期HCC组比,差异均有统计学意义(P<0.05)。自身免疫性肝炎、脂肪肝、病毒性肝炎和HCC高危人群血清GP73浓度与健康对照组相比,差异均有统计学意义(P<0.05)。其他肿瘤组的GP73浓度与对照组和HCC组,差异均有统计学意义(P<0.05)。结论 MP-CLIA法测定血清GP73结果可靠,GP73是一个HCC早期诊断的血清标志物。

Objective To detect serum Golgi protein 73（GP73） by chemiluminescence immunoassay（MP-CLIA） and further investigate its clinical applications with a variety of clinical samples including hepatocellular carcinoma （HCC）, liver cirrhosis and hepatitis.Methods In our study, the serum GP73 level was measured among healthy controls and patients groups by MP-CLIA.The MP-CLIA and ELISA method were evaluated in HCC diagnosis by means of calculating the area under the receiver operating characteristic （ROC）.We also measured serum GP73 and alpha-fetoprotein （AFP） in 50 cirrhosis and 69 HCC patients and further compared the effectiveness GP73 and AFP of clinical diagnosis for HCC.We investigated the early diagnosis value of serum GP73 by comparing with different pathological stages of 69 HCC.We also compared the serum GP73 level of healthy controls with that of other benign liver diseases and other cancers.Results It was shown that there was no statistical difference （P〉0.05） as to the ROC between the above two methods.It was also shown that the levels of serum GP73 were statistically significant among HCC group, liver cirrhosis group and control group （P〈0.05）.Serum GP73 level in T1, T2, T3, and T4 stage of HCC were 1.88nmol/L, 2.72nmol/L, 3.22nmol/L and 3.44 nmol/L, respectively.The concentration of serum GP73 in early stage of HCC was significantly different from advanced stage of HCC and liver cirrhosis （P〈0.05）.As a result, there were also statistical differences of serum GP73 between control group and autoimmune hepatitis, fatty liver, hepatitis, high-risk for HCC group as well as other cancer groups, respectively （P〈0.05）.Conclusion By clinical preliminary verification, GP73, whose level enhanced in the serum from HCC patients by MP-CLIA, is proved to be a sensitive serum marker in early diagnosis for HCC.