间接法建立乌鲁木齐地区AFP、CEA、CA72-4和CA19-9参考区间

doi:10.3969/j.issn.1673-8640.2025.11.004

摘要/Abstract

摘要：

目的采用间接法建立乌鲁木齐地区甲胎蛋白（AFP）、癌胚抗原（CEA）、糖类抗原72-4（CA72-4）和糖类抗原19-9（CA19-9）参考区间。方法收集2021年1月—2024年7月新疆生产建设兵团医院实验室信息系统（LIS）中体检人群的AFP、CEA、CA72-4和CA19-9数据。采用Tukey法剔除离群值。基于多因素线性回归和方差分量模型计算标准差比率（SDR）和偏倚比判断是否需要按性别和年龄分别建立参考区间。采用非参数法建立各项指标的95%参考区间，计算各项指标参数区间上限值与直接法建立参考区间的相对偏差，并与各项指标的参考变化值（RCV）进行比较。结果 AFP的SDR<0.3，偏倚比=0.489，需按性别建立参考区间（男性为<7.55 ng·mL^-1、女性为<6.67 ng·mL^-1）。CEA性别和年龄的SDR分别为0.324、0.553，需按性别和年龄建立参考区间（男性<60岁为<4.54 ng·mL^-1、≥60岁为<5.85 ng·mL^-1；女性<60岁为<2.89 ng·mL^-1、≥60岁为<5.65 ng·mL^-1）。CA72-4和CA19-9的参考区间分别为<13.7和<24.85 U·mL^-1。间接法AFP、CEA、CA72-4和CA19-9参考区间的上限值与直接法参考区间的相对偏差均低于RCV。结论采用间接法建立的乌鲁木齐地区AFP、CEA、CA72-4和CA19-9 参考区间与直接法建立的参考区间具有良好的一致性，可为临床决策提供更加适合不同人群的参考区间。

关键词: 甲胎蛋白, 癌胚抗原, 糖类抗原72-4, 糖类抗原19-9, 间接法, 大数据, 参考区间

Abstract:

Objective To establish the reference ranges for alpha-fetoprotein（AFP），carcinoembryonic antigen（CEA），carbohydrate antigen 72-4（CA72-4）and carbohydrate antigen 19-9（CA19-9）in Urumqi region by indirect method. Methods The data of AFP，CEA，CA72-4 and CA19-9 from laboratory information system（LIS）of Xinjiang Production and Construction Corps Hospital from January 2021 to July 2024 were collected. Outliers were removed using the Tukey method. The standard deviation ratio（SDR）and deviation ratio were calculated based on multiple-factor linear regression and variance component models to determine whether separate reference ranges should be established by gender and age. The 95% reference ranges for each indicator were established using non-parametric methods. The relative deviation between the upper limit of each indicator reference range and the reference range established by direct method was calculated，compared to reference change value（RCV）. Results The SDR of AFP was <0.3，and the deviation ratio was 0.489，indicating that separate reference ranges should be established by gender （male<7.55 ng·mL^-1，female<6.67 ng·mL^-1）. The SDR of CEA by gender and age were 0.324 and 0.553，respectively，indicating that separate reference ranges should be established by gender and age （male<60 years old<4.54 ng·mL^-1，≥60 years old<5.85 ng·mL^-1；female<60 years old < 2.89 ng·mL^-1，≥60 years old <5.65 ng·mL^-1）. The reference ranges of CA72-4 and CA19-9 were <13.7 and <24.85 U·mL^-1，respectively. The upper limits of the self-established reference ranges of AFP，CEA，CA72-4 and CA19-9 were within the relative deviation of RCV from the reference ranges established by direct method. Conclusions The reference ranges for AFP，CEA，CA72-4 and CA19-9 established in Urumqi region using indirect method have good consistency with those established by direct method，which can provide more appropriate reference ranges for clinical decision-making，suitable for different people.

Key words: Alpha-fetoprotein, Carcinoembryonic antigen, Carbohydrate antigen 72-4, Carbohydrate antigen 19-9, Indirect method, Big datum, Reference range

中图分类号:

R446.1

刘春燕, 牛书敏, 邓朝晖, 梁梦洁, 张新. 间接法建立乌鲁木齐地区AFP、CEA、CA72-4和CA19-9参考区间[J]. 检验医学, 2025, 40(11): 1053-1058.

LIU Chunyan, NIU Shumin, DENG Zhaohui, LIANG Mengjie, ZHANG Xin. Establishing the reference ranges for AFP，CEA，CA72-4 and CA19-9 in Urumqi region by indirect method[J]. Laboratory Medicine, 2025, 40(11): 1053-1058.

图/表 6

参考文献 26

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项目	原始数据/例	离群值/ 例	纳入数据
项目	原始数据/例	离群值/ 例	男性/例	女性/例	合计/例
AFP	10 832	346	6 408	4 178	10 586
CEA	10 310	252	6 261	3 797	10 058
CA72-4	7 397	152	3 878	3 367	7 245
CA19-9	7 351	173	4 171	3 007	7 178

项目	原始数据/例	离群值/ 例	纳入数据
项目	原始数据/例	离群值/ 例	男性/例	女性/例	合计/例
AFP	10 832	346	6 408	4 178	10 586
CEA	10 310	252	6 261	3 797	10 058
CA72-4	7 397	152	3 878	3 367	7 245
CA19-9	7 351	173	4 171	3 007	7 178

项目	性别^①		年龄^②
	β值	P值	A1		A2
	β值	P值	β值	P值	β值	P值
AFP	-0.039	<0.001	0.179	<0.001		0.102	<0.001
CEA	0.212	<0.001	0.151	<0.001		0.343	<0.001
CA72-4	-0.043	<0.001	0.026	0.027		-0.028	0.017
CA19-9	-0.094	<0.001	0.082	<0.001		0.209	<0.001

项目	性别^①		年龄^②
	β值	P值	A1		A2
	β值	P值	β值	P值	β值	P值
AFP	-0.039	<0.001	0.179	<0.001		0.102	<0.001
CEA	0.212	<0.001	0.151	<0.001		0.343	<0.001
CA72-4	-0.043	<0.001	0.026	0.027		-0.028	0.017
CA19-9	-0.094	<0.001	0.082	<0.001		0.209	<0.001

项目	s残余	性别			年龄
项目	s残余	s	SDR	偏倚比	s	SDR	偏倚比
AFP	1.903	0.062	0.033	0.489	0.111	0.058	0.267
CEA	0.414	0.134	0.324		0.229	0.553
CA72-4	1.554	0.965	0.221	0.086	0.768	0.194	0.293
CA19-9	2.452	0.062	0.025	0.315	0.102	0.042	0.269