Villar-del-Campo M C, Rodríguez-Caravaca G, Gil-Yonte P, Cidoncha-Calderón E, García-Cruces Méndez J, Donnay-Pérez S
Centro de Salud Los Cármenes, Madrid, España.
Unidad de Medicina Preventiva y Salud Pública, Hospital Universitario Fundación Alcorcón, Madrid, España; Departamento de Medicina Preventiva y Salud Pública, Universidad Rey Juan Carlos, Madrid, España.
Semergen. 2014 Nov-Dec;40(8):431-5. doi: 10.1016/j.semerg.2014.01.012. Epub 2014 Apr 4.
Several methods are available for measuring glycosylated A1c hemoglobin (HbA1c), all rapid methods for point of care use in a clinical or laboratory setting. This study attempts to compare the diagnostic agreement between two methods for detection of HbA1c.
A descriptive cross-sectional study of diagnostic agreement was carried out in the Los Carmenes Health Centre. Two groups of patients -with and without type 2 diabetes- were consecutively included. A method for point-of-care use in a Primary Care Clinic setting (DCA(TM) Systems Siemens(®)) was compared with a laboratory test (chromatographic analysis). An analysis was made of the mean concentration of HbA1c, the agreement between methods, using the intra-class correlation coefficient (CCLA1) and the Bland-Altman method.
A total of 102 patients were included, 62 diabetic (60.8%) and 40 non-diabetic (39.2%). The overall mean HbA1c was 6.46% (SD=0.88) in the analysis using capillary blood in the clinic with the DCA™ system, and 6.44% (SD=0.86) using the laboratory test (P>.05). The degree of agreement between the two tests was 0.975 (95% CI: 0.963-0.983). The mean of the differences between the results of the two assessed tests was 0.024 (SD=0.27). The percentage of points outside the limits of optimal agreement, as defined in the Bland-Altman graph, was 2.5%.
Diagnostic agreement between a method for point-of-care use in a Primary Health Care Clinic and a laboratory test was very high. Detection at the point-of-care allows a quick and simple assessment of HbA1c.
有多种方法可用于测量糖化血红蛋白A1c（HbA1c），所有这些方法都是适用于临床或实验室即时检测的快速方法。本研究旨在比较两种检测HbA1c方法之间的诊断一致性。
在洛斯卡门斯健康中心开展了一项关于诊断一致性的描述性横断面研究。连续纳入两组患者，一组患有2型糖尿病，另一组未患2型糖尿病。将一种适用于初级保健诊所即时检测的方法（西门子DCA™系统）与实验室检测方法（色谱分析）进行比较。分析了HbA1c的平均浓度、两种方法之间的一致性，采用组内相关系数（CCLA1）和布兰德-奥特曼方法。
共纳入102例患者，其中62例为糖尿病患者（60.8%），40例为非糖尿病患者（39.2%）。在诊所使用DCA™系统对毛细血管血进行分析时，总体平均HbA1c为6.46%（标准差=0.88），而采用实验室检测时为6.44%（标准差=0.86）（P>0.05）。两种检测方法之间的一致性程度为0.975（95%置信区间：0.963 - 0.983）。两种评估检测结果之间差异的平均值为0.024（标准差=0.27）。根据布兰德-奥特曼图定义，超出最佳一致性限度的点的百分比为2.5%。
初级卫生保健诊所即时检测方法与实验室检测之间的诊断一致性非常高。即时检测能够快速、简单地评估HbA1c。
