The First Branch, The First Affiliated Hospital of Chongqing Medical University , Chongqing , China.
Scand J Clin Lab Invest. 2019 Nov;79(7):484-490. doi: 10.1080/00365513.2019.1661008. Epub 2019 Sep 5.
The aim of this study is to establish the reference intervals (RIs) for serum gastrointestinal tumor markers (AFP, CEA, CA199 and CA724) in healthy adults of Han nationality in Chongqing by Roche ECLIA system. According to CLSI EP28-A3, the appropriate statistical analysis method was selected and the RIs were determined using the indirect method based on the analysis results. All the test data of the four research projects showed a skewness distribution ( < .05). Gender and age are two important factors influencing the level of detection value. According to the analysis results, the data of the four research projects were grouped by gender and age, and the non-parametric percentile method (95%, double-sided) was used to establish the RIs of each group. The established RIs were validated using the method of Reference Change Value (RCV). The relative deviations between the upper limit value of reference interval in each group of AFP and CEA and that provided by the manufacturer is all smaller than the RCV of eath, so the RIs established by this study is proved to be reliable. While, the relative deviation of the group CEA (male > 40 years old, female > 60 years old) and CA724 is higher than each RCV, which indicates that the RIs provided by the manufacturer is not applicable to the test population and test system of the laboratory. We established RIs of serum gastrointestinal tumor markers (AFP, CEA, CA199 and CA724) in healthy adults of Han nationality in Chongqing by Roche ECLIA system. Furthermore, our study suggests that it is necessary to establish the age-specific and sex-specific RIs for gastrointestinal tumor markers in different detection systems.
本研究旨在通过罗氏电化学发光法（ECLIA）建立重庆地区汉族健康成年人血清胃肠道肿瘤标志物（AFP、CEA、CA199 和 CA724）的参考区间（RIs）。根据 CLSI EP28-A3，选择适当的统计分析方法，基于分析结果，采用间接法确定 RIs。四项研究项目的所有检测数据均呈偏态分布（ < .05）。性别和年龄是影响检测值水平的两个重要因素。根据分析结果，将四项研究项目的数据按性别和年龄分组，采用非参数百分位数法（95%，双侧）建立各年龄组的 RIs。采用参考变化值（RCV）法对建立的 RIs 进行验证。AFP 和 CEA 各参考区间上限值与厂家提供值的相对偏差均小于各项目的 RCV，说明本研究建立的 RIs 可靠。而 CEA（男性>40 岁，女性>60 岁）和 CA724 组的相对偏差均高于各 RCV，表明厂家提供的 RIs 不适用于本实验室的检测人群和检测系统。我们通过罗氏 ECLIA 系统建立了重庆地区汉族健康成年人血清胃肠道肿瘤标志物（AFP、CEA、CA199 和 CA724）的 RIs。此外，本研究提示不同检测系统的胃肠道肿瘤标志物需要建立年龄和性别特异性的 RIs。
