健康个体血清中CA 19-9、癌胚抗原（CEA）、甲胎蛋白（AFP）的生物学变异及参考变化值

Biological variation and reference change values of CA 19-9, CEA, AFP in serum of healthy individuals.

作者信息

Erden G, Barazi A O, Tezcan G, Yildirimkaya M M

机构信息

Department of Clinical Biochemistry, Ankara Numune Education and Research Hospital, Ankara, Turkey.

出版信息

Scand J Clin Lab Invest. 2008;68(3):212-8. doi: 10.1080/00365510701601699.

DOI:10.1080/00365510701601699

PMID:17926198

Abstract

OBJECTIVE

The use of tumour markers in diagnosis and monitoring is very common. Tumour marker results vary - preanalytical sources of variation, total random analytical error (CV(a)), and within-subject (intraindividual) normal biological variation. There are not so many studies evaluating the biological variations and reference change values (RCV) of these parameters. The aim of our study was to assess: (i) the average inherent intra- and inter-individual biological variation (CV(i) and CV(g)) for CA 19-9, CEA, AFP in a group of healthy individuals; (ii) the significance of changes in serial results of each marker; and (iii) the index of individuality.

MATERIAL AND METHODS

The study group comprised 49 healthy volunteers ranging in age between 18 and 60 years (25 M and 24 F). Four blood samples were obtained from each subject; one at each 14-day interval. Each sample from one individual was assayed in duplicate. CA 19-9, CEA, AFP levels were measured by an immunoluminometric assay on a random-access analyser (Architect i2000; Abbott Diagnostics Division). The intra- (CV(i)) and inter-individual (CV(g)) biological variations were estimated from the data generated. Reference change value (RCV) was calculated.

RESULTS

The intra-individual/inter-individual biological variations (CVs) for CA 19-9, CEA, AFP were 27.2/64.24 %, 30.87/37.14 % and 26.67/43.65 %, respectively. The critical differences (RCVs) of CA 19-9, CEA, AFP were 64.71 %, 72.57 % and 62.62 %, respectively (Z = 1.65 for unidirectional changes; p<0.05).

CONCLUSIONS

Intra-individual biological variation contributes to the variation in serial results and should therefore be included in the criteria for serum tumour marker assessment.

摘要

目的

肿瘤标志物在诊断和监测中的应用非常普遍。肿瘤标志物的结果存在差异——包括分析前的变异来源、总随机分析误差（CV(a)）以及个体内正常生物学变异。评估这些参数的生物学变异和参考变化值（RCV）的研究并不多。我们研究的目的是评估：（i）一组健康个体中CA 19-9、癌胚抗原（CEA）、甲胎蛋白（AFP）的平均个体内和个体间固有生物学变异（CV(i)和CV(g)）；（ii）每个标志物系列结果变化的意义；（iii）个体性指数。

材料与方法

研究组包括49名年龄在18至60岁之间的健康志愿者（25名男性和24名女性）。从每个受试者采集4份血样；每隔14天采集一份。每个个体的每份样品进行双份检测。CA 19-9、CEA、AFP水平通过随机接入分析仪（Architect i2000；雅培诊断部）上的免疫发光分析法进行测定。根据生成的数据估计个体内（CV(i)）和个体间（CV(g)）生物学变异。计算参考变化值（RCV）。