Department of Endocrinology, Postgraduate Institute of Medical Education and Research, Chandigarh 160012, India.
J Clin Endocrinol Metab. 2010 Jun;95(6):2832-5. doi: 10.1210/jc.2009-2433. Epub 2010 Apr 6.
Although glycated hemoglobin (HbA1c) has recently been incorporated as a diagnostic test by the American Diabetes Association, its validity needs to be established in Asian Indians in a community setting.
The objective of the study was to assess the validity of HbA1c as a screening and diagnostic test in individuals with newly detected diabetes mellitus.
Community based randomized cross sectional study in urban Chandigarh, a city in north India, from April 2008 to August 2009.
Subjects included 1972 subjects aged 20 yr or older.
Intervention included an oral glucose tolerance test and glycated hemoglobin in all the subjects.
Utility of HbA1c as a diagnostic method in newly detected diabetes mellitus subjects was evaluated.
Using World Health Organization criteria for diagnosis of diabetes mellitus, 134 (6.7%) had newly detected diabetes mellitus, 192 (9.7%) known diabetes mellitus, 329 (16.6%) prediabetes, and 1317 (69.4%) were normal of 1972 people screened. Using only the ADA criteria, 38% people were underdiagnosed. An HbA1c level of 6.1% had an optimal sensitivity and specificity of 81% for diagnosing diabetes. A HbA1c level of 6.5% (+/-2 SD) and 7% (+/-2.7 SD) had sensitivity and specificity of 65 and 88% and 42 and 92%, respectively, with corresponding positive predictive value and negative predictive value of 75.2 and 96.5% and 90.4 and 94.4%, respectively, for diagnosis of newly detected diabetes mellitus.
A HbA1c cut point of 6.1% has an optimal sensitivity and specificity of 81% and can be used as a screening test, and a cut point of 6.5% has optimal specificity of 88% for diagnosis of diabetes.
尽管糖化血红蛋白(HbA1c)最近已被美国糖尿病协会纳入诊断测试,但在社区环境中的亚洲印第安人群体中,其有效性仍需确定。
本研究旨在评估 HbA1c 作为新诊断糖尿病患者筛查和诊断测试的有效性。
2008 年 4 月至 2009 年 8 月,在印度北部城市昌迪加尔进行的基于社区的随机横断面研究。
受试者包括 1972 名年龄在 20 岁或以上的人。
所有受试者均接受口服葡萄糖耐量试验和糖化血红蛋白检查。
评估 HbA1c 作为新诊断糖尿病患者诊断方法的效用。
根据世界卫生组织糖尿病诊断标准,134 人(6.7%)患有新诊断的糖尿病,192 人(9.7%)患有已知的糖尿病,329 人(16.6%)患有糖尿病前期,1317 人(69.4%)为正常。仅使用 ADA 标准,38%的人被漏诊。HbA1c 水平为 6.1%时,诊断糖尿病的敏感性和特异性最佳,分别为 81%。HbA1c 水平为 6.5%(+/-2 SD)和 7%(+/-2.7 SD)时,敏感性和特异性分别为 65%和 88%,42%和 92%,相应的阳性预测值和阴性预测值分别为 75.2%和 96.5%,90.4%和 94.4%。
HbA1c 切点为 6.1%时,敏感性和特异性最佳,分别为 81%,可作为筛查试验;切点为 6.5%时,特异性最佳,为 88%,可用于诊断糖尿病。