基于微阵列化学发光免疫分析系统的血清肿瘤标记物CA72-4参考区间建立

Establishment of Reference Interval for the Serum Tumour Marker CA72-4 Measured by the Microarray Chemiluminescence Immunoassay System

摘要: 目的：目前，多种血清肿瘤标记物已应用于癌症的诊断、治疗和预后监测。因此，建立合适的肿瘤标记物的参考区间(RI)对于临床医生制定正确的治疗方案非常重要。本研究旨在通过实验室新设立的微阵列化学发光免疫分析系统(MCI)来建立血清糖类抗原72-4 (CA72-4)的参考区间。方法：根据CLSI EP28-A3，选择了相应的统计学分析方法，并基于分析结果采用间接法确定参考区间。研究共选用5937名健康参考个体，通过MCI系统测定的CA72-4血清水平来确定参考区间。这四个研究项目的所有测试数据都呈偏态分布。首先，性别和年龄是影响检测价值水平的两个重要因素。其次，按性别和年龄对数据进行分组，使用非参数排序法建立每个组的参考区间。结果：血清CA72-4水平总体呈偏态分布，不同性别、年龄组的血清CA72-4水平无统计学意义。因此，可以通过非参数排序法，按照95%置信区间计算出健康个体的CA72-4参考区间是0~13.34 U/mL。结论：新建立的参考区间更适合国内研发的MCI系统，对于临床医学诊断和治疗管理决策更有价值。

Abstract: Purpose: A variety of serum biomarkers have been applied to the diagnosis, treatment and prog-nosis monitoring of cancers. So, appropriate reference intervals (RI) of tumour markers are im-portant for clinicians to make a right clinical practice. In this study, we aimed to establish the RIs for the carbohydrate antigen 72-4 (CA72-4) measured by the newly developed microarray chemiluminescence immunoassay (MCI) system in our laboratory. Methods: 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. A total of 5937 healthy reference indi-viduals were selected and their serum level of CA72-4 measured by MCI system were analysed in this study to establish the reference interval. All the test data of the four research projects showed a skewness distribution. Firstly, gender and age are two important factors influencing the level of detection value. Next, the data were grouped by gender and age, and the non-parametric percentile method was used to establish the RIs of each group. Results: The results showed the distribution for serum CA72-4 level was skewed and the serum CA72-4 levels among gender and age subgroups were no statistically significant. Thus, the RI of CA72-4 for healthy individuals was 0~13.34 U/mL defined by nonparametric 95th percentile interval, which also had passed through the RI verification. Conclusion: The novel established RI was more appropriate for the domestic developed MCI system, which was of great value in medical diagnosis and therapeutic management decision.