厦门地区成年健康人群癌胚抗原参考范围调查

Investigation of the Reference Range of Carcinoembryonic Antigen of Healthy Adults in Xiamen

目的初步建立厦门地区健康人群血清癌胚抗原（CEA）的参考值范围。方法用罗氏Elecsys2010全自动电化学发光免疫分析仪及CEA测定原装配套试剂盒（电化学发光免疫测定法）对37742例成年健康人群的新鲜血清进行测定，其中男性23234例，女性14508例，测定结果按CLSIC28-A3（《临床实验室参考范围的定义和确认》第3版）进行统计处理，按年龄间隔10年和性另q分组，比较各组间及与推荐参考范围的差异。结果本研究男性CEA总体参考范围为〈4．42ng／ml，男性≤30岁，≤40岁，≤50岁，〉50岁CEA参考范围分别为〈3．84ng／ml，〈3．96ng／ml，〈4．77ng／ml和〈5．45ng／ml，≤30岁组与≤40岁组无明显差异（P=0．4301），其余各年龄组均有明显差异（P〈O．01）；女性CEA总体参考范围为〈3．89ng／ml，女性≤30岁，≤40岁，≤50岁，〉50岁CEA参考范围分别为〈2．32ng／ml，〈2．45ng／ml，〈2．82ng／ml，〈4．15ng／ml，各年龄组均有明显差异（P（0。01）。结论厦门地区成年健康人群CEA的95％医学参考范围存在年龄及性别差异，CEA参考范围随年龄增加而升高，且男性明显高于女性，故不宜通用，调查确定参考范围与推荐参考范围有差异。

Objective To determine the reference intervals of carcinoembryonic antigen for healthy adults in Xiamen city ac- cording to CLSI C28-A3. Methods 37 742 serum samples of healthy adults （23 260 of males and 14 508 of females） in Xia- men city were collected and each of the male group and female group were divided into four groups based on their ages ： group below 30,group below 40, group below 50,and group above 50. These samples were tested for their carcinoembryonic anti- gen（CEA） level by CEA assay kit（Roche） and statistically analyzed according to CLSI C28-A3. Results Among the 23 260 healthy adult men, the reference interval of 95% percentiles of CEA was 〈4. 42 ng/ml. The 95% percentiles of the group below 30,group below 40,group below 50 and group above 50 were determined to be 〈3.84 ng/ml,〈3.96 ng/ml,〈4.77 ng/ml,and 50 〈5.45 ng/ml,respeetively. There was a significant difference between each two group except for group below 30 and group below 40. For the females, the reference interval of 95 % percentiles was 〈3.89 ng/ml. The 95 % percentiles of the four groups were tested to be 〈2. 32 ng/ml,〈2.45 ng/ml,〈2. 82 ng/ml and 〈4. 15 ng/ml,respectively. There was a significant difference between each two groups. Conclusion The reference interval of 95% percentiles of CEA for healthy a- dults in Xiamen city varies by gender and age. The reference interval of 950/6 percentiles of males was higher than that of fe- males and it increased in parallel with the age of people. So we recommended the reference interval of CEA measured by Roche CEA assay kit should not be generally used between males and females,and between different age groups.