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

1.	張雨薇, 歐袁偉翔, 熊真真, 等. 2014年糖尿病重要臨床指南和共識進展回顧. 中國循證醫學雜志, 2015, 15(8): 867-872.
2.	劉蔚, 紀立農. 2011年全國糖化血紅蛋白檢測儀器現況調查. 中國糖尿病雜志, 2013, 21(8): 682-685.
3.	衛生部臨床檢驗中心. 糖化血紅蛋白實驗室檢測指南(2011年版). 中國糖尿病雜志, 2013, 21(8): 673-678.
4.	WS/T402-12-2012. 臨床實驗室檢驗項目參考區間的制定. WS, 2012.
5.	CLSI C28-A3. Defining, establishing, and verifying reference intervals in the clinical laboratory; approved guideline-third edition. CLSI, 2010.
6.	中華人民共和國衛生部醫政司. 全國臨床檢驗操作規程. 第三版. 南京: 東南大學出版社, 2006: 82-99.
7.	宋秀國, 唐振起. 渤海新區2687例成人糖化血紅蛋白水平分析. 檢驗醫學與臨床, 2013, 10(4): 431-432.
8.	馬小紅, 莊愛周, 李萌, 等. 杭州地區部分人群糖化血紅蛋白的調查研究. 中國衛生檢驗雜志, 2012, 22(1): 144-148.
9.	王奇軍, 陳佩, 曾琴飛, 等. 寧波地區健康成人糖化血紅蛋白水平調查. 中國衛生檢驗雜志, 2014, 24(19): 2862-2866.
10.	施俊柱, 劉愛勝, 陳榮貴, 等. 深圳龍華新區人群全血糖化血紅蛋白情況研究分析. 國際檢驗醫學雜志, 2013, 34(22): 3033-3034.
11.	中華人民共和國國家衛生和計劃生育委員會醫政醫管局. 全國臨床檢驗操作規程. 第四版. 北京: 人民衛生出版社, 2015: 234-237.
12.	中華醫學會糖尿病學分會. 中國2型糖尿病防治指南(2010年版). 中國糖尿病雜志, 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.	中華醫學會糖尿病學分會. 中國血糖監測臨床應用指南(2011年版). 中華糖尿病雜志, 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. 張雨薇, 歐袁偉翔, 熊真真, 等. 2014年糖尿病重要臨床指南和共識進展回顧. 中國循證醫學雜志, 2015, 15(8): 867-872.
2. 劉蔚, 紀立農. 2011年全國糖化血紅蛋白檢測儀器現況調查. 中國糖尿病雜志, 2013, 21(8): 682-685.
3. 衛生部臨床檢驗中心. 糖化血紅蛋白實驗室檢測指南(2011年版). 中國糖尿病雜志, 2013, 21(8): 673-678.
4. WS/T402-12-2012. 臨床實驗室檢驗項目參考區間的制定. WS, 2012.
5. CLSI C28-A3. Defining, establishing, and verifying reference intervals in the clinical laboratory; approved guideline-third edition. CLSI, 2010.
6. 中華人民共和國衛生部醫政司. 全國臨床檢驗操作規程. 第三版. 南京: 東南大學出版社, 2006: 82-99.
7. 宋秀國, 唐振起. 渤海新區2687例成人糖化血紅蛋白水平分析. 檢驗醫學與臨床, 2013, 10(4): 431-432.
8. 馬小紅, 莊愛周, 李萌, 等. 杭州地區部分人群糖化血紅蛋白的調查研究. 中國衛生檢驗雜志, 2012, 22(1): 144-148.
9. 王奇軍, 陳佩, 曾琴飛, 等. 寧波地區健康成人糖化血紅蛋白水平調查. 中國衛生檢驗雜志, 2014, 24(19): 2862-2866.
10. 施俊柱, 劉愛勝, 陳榮貴, 等. 深圳龍華新區人群全血糖化血紅蛋白情況研究分析. 國際檢驗醫學雜志, 2013, 34(22): 3033-3034.
11. 中華人民共和國國家衛生和計劃生育委員會醫政醫管局. 全國臨床檢驗操作規程. 第四版. 北京: 人民衛生出版社, 2015: 234-237.
12. 中華醫學會糖尿病學分會. 中國2型糖尿病防治指南(2010年版). 中國糖尿病雜志, 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. 中華醫學會糖尿病學分會. 中國血糖監測臨床應用指南(2011年版). 中華糖尿病雜志, 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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