Investigating the Glycated Hemoglobin HbA1c Concentration and Reference Range of Healthy Adults in Quanzhou_Chinese Journal of Evidence-Based Medicine

Authors：

LINZhen-zhong ¹ , CHENYa-bin ¹ , JIANGJian-jia ² , LUOShi-mu ¹ , CHENZi-xuan ¹ , CHENHui-hua ¹ ,  MINGDe-song ¹

1. Department of Laboratory Medicine, Affiliated the First Hospital of Quanzhou, Fujian Medical University, Quanzhou 362000, China;
2. Department of Endocrinology, Affiliated the First Hospital of Quanzhou, Fujian Medical University, Quanzhou 362000, China;

Corresponding author：

MINGDe-song, Email: mds6430@126.com

Keywords：

HbA1c; Adult; Reference range; Age; Gender

DOI：

10.7507/1672-2531.20160171

Video：

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Objective To analyze the glycated hemoglobin A1c (HbA1c) level among healthy adults in Quanzhou area and explore distribution of HbA1c concentration by age and gender, and establish relevant reference range. Methods Under the standardized test of HbA1c, HbA1c concentrations of 1 931 healthy adults were determined by HLC-723 G8 HbA1c analyzer (TOSOH corp, Japan) and its agents. HbA1c levels of different age (18-30, 31-40, 41-50, 51-60, >60) and gender groups were compared, percentile was adopted to establish the corresponding HbA1c reference range of healthy adults in Quanzhou area according to "WS/T402-12-2012. Define and Determine the Reference Interval in Clinical Laboratory" and CLSI C28-A3. Results The total HbA1c levels among healthy adults in Quanzhou area were 3.8%-6.4% (5.31%±0.40%), and the total HbA1c levels among male and female healthy adults in Quanzhou area were 5.55%±0.36% and 5.47%±0.43%, respectively, HbA1c concentration between different gender were statistically significant (P≤0.01). Compared in HbA1c levels of different age (18-30, 31-40, 41-50, 51-60, >60) and gender groups: the difference of HbA1c concentration between different gender in 18-30 years and 31-40 years group was statistically significant (P<0.05) and on the contrary the remaining three age groups were no statistically significant. Compared in HbA1c levels of different age groups in male: the difference of HbA1c concentration between different age groups in 31-40 years and 41-50 years group were no statistically significant (P>0.05), but statistically significant (P<0.05) in the remaining three age groups. The difference of HbA1c concentration between different age groups in female were statistically significant (all P values ≤0.01). The reference intervals of HbA1c for males and females were 4.8%-6.2% and 4.6%-6.3%, respectively, with statistically significant (P=0.000); the reference intervals of HbA1c according to age and gender were: for 18-30 years in males and females were 4.6%-6.0% and 4.4%-6.0%, respectively, with statistically significant (P≤0.01); for 31-40 years in males and females were 4.7%-6.0% and 4.7%-6.2%, respectively, with statistically significant (P≤0.01); for 41-50 years, 51-60 years, >60 years in males and females were no statistically significant (P>0.05), the reference intervals were 4.8%-6.2%, 4.8%-6.4%, and 5.1%-6.4%, respectively. Compared in HbA1c reference intervals in this paper with ADA and Chinese Clinical Operating Program, the difference were statistically significant (P=0.000). Conclusion Under the standardized test of HbA1c, HbA1c concentrations of age and gender groups of 1 931 healthy adults in Quanzhou area are partial different, the reference interval of HbA1c of age and gender groups for healthy adults in Quanzhou area are established.

Citation： LINZhen-zhong, CHENYa-bin, JIANGJian-jia, LUOShi-mu, CHENZi-xuan, CHENHui-hua, MINGDe-song. Investigating the Glycated Hemoglobin HbA1c Concentration and Reference Range of Healthy Adults in Quanzhou. Chinese Journal of Evidence-Based Medicine, 2016, 16(10): 1121-1126. doi: 10.7507/1672-2531.20160171 Copy

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3.	卫生部临床检验中心. 糖化血红蛋白实验室检测指南(2011年版). 中国糖尿病杂志, 2013, 21(8): 673-678.
4.	WS/T402-12-2012. 临床实验室检验项目参考区间的制定. WS, 2012.
5.	CLSI C28-A3. Defining, establishing, and verifying reference intervals in the clinical laboratory; approved guideline-third edition. CLSI, 2010.
6.	中华人民共和国卫生部医政司. 全国临床检验操作规程. 第三版. 南京: 东南大学出版社, 2006: 82-99.
7.	宋秀国, 唐振起. 渤海新区2687例成人糖化血红蛋白水平分析. 检验医学与临床, 2013, 10(4): 431-432.
8.	马小红, 庄爱周, 李萌, 等. 杭州地区部分人群糖化血红蛋白的调查研究. 中国卫生检验杂志, 2012, 22(1): 144-148.
9.	王奇军, 陈佩, 曾琴飞, 等. 宁波地区健康成人糖化血红蛋白水平调查. 中国卫生检验杂志, 2014, 24(19): 2862-2866.
10.	施俊柱, 刘爱胜, 陈荣贵, 等. 深圳龙华新区人群全血糖化血红蛋白情况研究分析. 国际检验医学杂志, 2013, 34(22): 3033-3034.
11.	中华人民共和国国家卫生和计划生育委员会医政医管局. 全国临床检验操作规程. 第四版. 北京: 人民卫生出版社, 2015: 234-237.
12.	中华医学会糖尿病学分会. 中国2型糖尿病防治指南(2010年版). 中国糖尿病杂志, 2012, 20(1): 81-117.
13.	American Diabetes Association. International expert committee report on the role of the A1c assay in the diagnosis of diabetes. Diabetes Care, 2009, (7): 1327-1334.
14.	中华医学会糖尿病学分会. 中国血糖监测临床应用指南(2011年版). 中华糖尿病杂志, 2011, 3(1): 13-21.
15.	Roberts WL, Safa-PourS, DeBK, et al. Effects of hemoglobin C and S traits on glycohemo-globin measurements by eleven methods. Clin Chem, 2005, 51(4): 776-778.
16.	HermanWH, Ma Y, Uwaifo G, et al. Differences in A1c by race and ethnicity among patients with impaired glucose tolerance in the Diabetes Prevention Program. Diabetes Care, 2007, 30(10): 2453-2457.
17.	Pani LN, Korenda L, Meigs JB, et al. Effects of aging on A1C levels in individuals without diabetes. Diabetes Care, 2008, 31(10): 1991-1996.

1. 张雨薇, 欧袁伟翔, 熊真真, 等. 2014年糖尿病重要临床指南和共识进展回顾. 中国循证医学杂志, 2015, 15(8): 867-872.
2. 刘蔚, 纪立农. 2011年全国糖化血红蛋白检测仪器现况调查. 中国糖尿病杂志, 2013, 21(8): 682-685.
3. 卫生部临床检验中心. 糖化血红蛋白实验室检测指南(2011年版). 中国糖尿病杂志, 2013, 21(8): 673-678.
4. WS/T402-12-2012. 临床实验室检验项目参考区间的制定. WS, 2012.
5. CLSI C28-A3. Defining, establishing, and verifying reference intervals in the clinical laboratory; approved guideline-third edition. CLSI, 2010.
6. 中华人民共和国卫生部医政司. 全国临床检验操作规程. 第三版. 南京: 东南大学出版社, 2006: 82-99.
7. 宋秀国, 唐振起. 渤海新区2687例成人糖化血红蛋白水平分析. 检验医学与临床, 2013, 10(4): 431-432.
8. 马小红, 庄爱周, 李萌, 等. 杭州地区部分人群糖化血红蛋白的调查研究. 中国卫生检验杂志, 2012, 22(1): 144-148.
9. 王奇军, 陈佩, 曾琴飞, 等. 宁波地区健康成人糖化血红蛋白水平调查. 中国卫生检验杂志, 2014, 24(19): 2862-2866.
10. 施俊柱, 刘爱胜, 陈荣贵, 等. 深圳龙华新区人群全血糖化血红蛋白情况研究分析. 国际检验医学杂志, 2013, 34(22): 3033-3034.
11. 中华人民共和国国家卫生和计划生育委员会医政医管局. 全国临床检验操作规程. 第四版. 北京: 人民卫生出版社, 2015: 234-237.
12. 中华医学会糖尿病学分会. 中国2型糖尿病防治指南(2010年版). 中国糖尿病杂志, 2012, 20(1): 81-117.
13. American Diabetes Association. International expert committee report on the role of the A1c assay in the diagnosis of diabetes. Diabetes Care, 2009, (7): 1327-1334.
14. 中华医学会糖尿病学分会. 中国血糖监测临床应用指南(2011年版). 中华糖尿病杂志, 2011, 3(1): 13-21.
15. Roberts WL, Safa-PourS, DeBK, et al. Effects of hemoglobin C and S traits on glycohemo-globin measurements by eleven methods. Clin Chem, 2005, 51(4): 776-778.
16. HermanWH, Ma Y, Uwaifo G, et al. Differences in A1c by race and ethnicity among patients with impaired glucose tolerance in the Diabetes Prevention Program. Diabetes Care, 2007, 30(10): 2453-2457.
17. Pani LN, Korenda L, Meigs JB, et al. Effects of aging on A1C levels in individuals without diabetes. Diabetes Care, 2008, 31(10): 1991-1996.

Chinese Journal of Evidence-Based Medicine

Investigating the Glycated Hemoglobin HbA1c Concentration and Reference Range of Healthy Adults in Quanzhou

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