Laboratory Medicine Service, San Jorge General Hospital, Huesca, Spain.
Laboratory Medicine Service, Infanta Sofia Hospital- BR Salud, Madrid, Spain.
Int J Gynaecol Obstet. 2020 Aug;150(2):234-240. doi: 10.1002/ijgo.13178. Epub 2020 May 17.
To assess concordance between two point-of-care testing (POCT) devices and the standard laboratory method in screening for gestational diabetes mellitus (GDM) in Huesca.
Pregnant women who met criteria for an oral glucose tolerance test (OGTT) and attended the laboratory between October 2017 and November 2018 were recruited in this prospective observational study. Glucose was measured in venous (laboratory) and capillary blood (Accu-Chek or Contour Next glucometers). GDM was diagnosed attending to NDDG criteria for venous samples or capillary-specific cut-off. Linear regression, Passing-Bablok, Bland-Altman, and the kappa coefficient were used to study concordance between POCT and laboratory method.
Data from 109 women were analyzed (57 for Accu-Chek, 52 for Contour Next). Statistical analyses showed good agreement between both POCT and laboratory method. There were no statistical differences in fasting glucose measurements between capillary and venous samples and both POCT devices meet the ISO 15197 standard. Accu-Chek showed good agreement (k=0.629) regarding the laboratory method in classifying GDM, with an acceptable inter-evaluator bias of 3.5% (P<0.001).
POCT can be used to obtain fasting values and reduce overall waiting times for patients. Additionally, Accu-Chek can be used to diagnose GDM in remote areas applying specific cut-off values.
评估在韦斯卡(Huesca)使用两种即时检测(POCT)设备与标准实验室方法筛查妊娠期糖尿病(GDM)的一致性。
本前瞻性观察研究纳入了 2017 年 10 月至 2018 年 11 月期间符合口服葡萄糖耐量试验(OGTT)条件并在实验室就诊的孕妇。在静脉(实验室)和毛细血管(Accu-Chek 或 Contour Next 血糖仪)血中测量血糖。根据静脉样本的 NDDG 标准或毛细血管特定截断值诊断 GDM。使用线性回归、Passing-Bablok、Bland-Altman 和kappa 系数研究 POCT 与实验室方法之间的一致性。
分析了 109 名女性的数据(Accu-Chek 组 57 例,Contour Next 组 52 例)。统计分析显示两种 POCT 与实验室方法之间具有良好的一致性。毛细血管与静脉样本之间的空腹血糖测量值无统计学差异,且两种 POCT 设备均符合 ISO 15197 标准。Accu-Chek 在分类 GDM 方面与实验室方法具有良好的一致性(k=0.629),具有可接受的 3.5%(P<0.001)的评价者间偏倚。
POCT 可用于获取空腹值并减少患者的总体等待时间。此外,Accu-Chek 可用于在应用特定截断值的偏远地区诊断 GDM。