Establishing the reference ranges for AFP，CEA，CA72-4 and CA19-9 in Urumqi region by indirect method

doi:10.3969/j.issn.1673-8640.2025.11.004

Abstract

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

CLC Number:

R446.1

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.

Figures/Tables 6

References 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