PDF(Pubmed)
Abstract：
UNASSIGNED: the utility of glycated haemoglobin (HbA1c) for the diagnosis and monitoring of diabetes in sub-Saharan Africa is uncertain due to limited data on the performance of the available HbA1c assay methods in this population, which has a high prevalence of haemoglobin variants. We aimed to compare the diagnostic accuracy of the major HbA1c methodologies (Boronate Affinity, Capillary Electrophoresis, High Performance Liquid Chromatography, Immunoassay) in an African population, and assess the impact of the common haemoglobin variant HbAS (sickle cell trait).
UNASSIGNED: whole blood samples were obtained from 182 individuals living with type 2 diabetes in Uganda. HbA1c values for each method were compared to average glucose measured over 14 days by continuous glucose monitoring (CGM). To determine concordance, the three HbA1c assay methods were compared to the capillary electrophoresis method.
UNASSIGNED: there was a strong correlation between CGM average glucose levels and all four HbA1c methodologies (r=0.81-0.89) which did not differ in those with and without HbAS (present in 37/182 participants). The presence of HbAS did not alter the relationship between HbA1c and CGM glucose for any assay (p for interaction >0.2 for all methods). Diagnostic accuracy for CGM average glucose thresholds of 7 and 10mmol/L was similar across methods (area under the receiver operating characteristic curve 0.80-0.84 and 0.76-0.84 respectively). The maximum bias between the HbA1c assay methodologies was 2 mmol/mol (2.07%).
UNASSIGNED: all major HbA1c technologies offer accurate and comparable HbA1c measurement even in this population with high prevalence of haemoglobin variants.
UNASSIGNED: whole blood samples were obtained from 182 individuals living with type 2 diabetes in Uganda. HbA1c values for each method were compared to average glucose measured over 14 days by continuous glucose monitoring (CGM). To determine concordance, the three HbA1c assay methods were compared to the capillary electrophoresis method.
UNASSIGNED: there was a strong correlation between CGM average glucose levels and all four HbA1c methodologies (r=0.81-0.89) which did not differ in those with and without HbAS (present in 37/182 participants). The presence of HbAS did not alter the relationship between HbA1c and CGM glucose for any assay (p for interaction >0.2 for all methods). Diagnostic accuracy for CGM average glucose thresholds of 7 and 10mmol/L was similar across methods (area under the receiver operating characteristic curve 0.80-0.84 and 0.76-0.84 respectively). The maximum bias between the HbA1c assay methodologies was 2 mmol/mol (2.07%).
UNASSIGNED: all major HbA1c technologies offer accurate and comparable HbA1c measurement even in this population with high prevalence of haemoglobin variants.
摘要：
■由于可用的HbA1c测定方法在该人群中的性能数据有限，因此在撒哈拉以南非洲的糖尿病诊断和监测中，糖化血红蛋白（HbA1c）的实用性尚不确定，血红蛋白变异的患病率很高。我们旨在比较主要HbA1c方法的诊断准确性(硼酸盐亲和力，毛细管电泳,高效液相色谱法,免疫测定）在非洲人口中，并评估常见血红蛋白变体HbAS（镰状细胞性状）的影响。
■全血样本来自乌干达182名2型糖尿病患者。将每种方法的HbA1c值与通过连续葡萄糖监测(CGM)在14天内测量的平均葡萄糖进行比较。为了确定一致性，将三种HbA1c检测方法与毛细管电泳法进行比较。
■CGM平均血糖水平与所有四种HbA1c方法（r=0.81-0.89）之间存在很强的相关性，在有和没有HbAS的情况下没有差异（存在于37/182参与者中）。对于任何测定,HbAS的存在都没有改变HbA1c和CGM葡萄糖之间的关系(对于所有方法,相互作用p>0.2)。CGM平均葡萄糖阈值为7和10mmol/L的诊断准确性在各种方法中相似（受试者工作特征曲线下面积分别为0.80-0.84和0.76-0.84）。HbA1c测定方法之间的最大偏差为2mmol/mol(2.07%)。
■所有主要的HbA1c技术都能提供准确和可比的HbA1c测量结果，即使在血红蛋白变异率很高的人群中也是如此。
■全血样本来自乌干达182名2型糖尿病患者。将每种方法的HbA1c值与通过连续葡萄糖监测(CGM)在14天内测量的平均葡萄糖进行比较。为了确定一致性，将三种HbA1c检测方法与毛细管电泳法进行比较。
■CGM平均血糖水平与所有四种HbA1c方法（r=0.81-0.89）之间存在很强的相关性，在有和没有HbAS的情况下没有差异（存在于37/182参与者中）。对于任何测定,HbAS的存在都没有改变HbA1c和CGM葡萄糖之间的关系(对于所有方法,相互作用p>0.2)。CGM平均葡萄糖阈值为7和10mmol/L的诊断准确性在各种方法中相似（受试者工作特征曲线下面积分别为0.80-0.84和0.76-0.84）。HbA1c测定方法之间的最大偏差为2mmol/mol(2.07%)。
■所有主要的HbA1c技术都能提供准确和可比的HbA1c测量结果，即使在血红蛋白变异率很高的人群中也是如此。
