Landberg Eva, Nevander Sofia, Hadi Mohammed, Blomberg Marie, Norling Anna, Ekman Bertil, Lilliecreutz Caroline
Department of Clinical Chemistry and Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden.
Department of Obstetrics and Gynecology, and Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden.
Scand J Clin Lab Invest. 2021 Dec;81(8):607-614. doi: 10.1080/00365513.2021.1980224. Epub 2021 Sep 24.
To diagnose gestational diabetes mellitus (GDM), plasma glucose measurements during oral glucose tolerance test (OGTT) put high demands on the methods in terms of accuracy. The aim was to evaluate and compare diagnostic performance of a point-of-care test and a glucose hexokinase laboratory method. Using risk-based screening, 175 pregnant women were included. They underwent a 75 g OGTT in their 28th (median) week of gestation. Venous blood was collected in two different tubes. Plasma glucose was measured on Cobas c701 and in duplicates on AccuChek Inform II (both methods from Roche Diagnostics). Accuracy was assessed by participating in external control programs with reference method assigned values. The methods were compared for all samples ( = 512) by regression analysis; slope of 0.90 (95% CI: 0.89-0.92), intercept of 0.12 (95% CI: 0.011-0.22) and r of 0.968. The average bias between AccuChek Inform II and Cobas c701 was -8%. The proportion of women diagnosed with GDM was 25% based on AccuChek Inform II versus 55% for Cobas c701. Results from the external control program showed a bias of approximately 5% for Cobas c701 and no significant bias for AccuChek Inform II. Cobas c701 showed a large bias both towards Accu-Chek Inform II and the reference method used in the external control program, clearly exceeding the desirable bias of <2.6%. The lack of accuracy has great implications on either over- or under-diagnosis of GDM.
为诊断妊娠期糖尿病（GDM），口服葡萄糖耐量试验（OGTT）期间的血浆葡萄糖测量对方法的准确性有很高要求。目的是评估和比较即时检验法与葡萄糖己糖激酶实验室方法的诊断性能。采用基于风险的筛查，纳入了175名孕妇。她们在妊娠第28周（中位数）时接受了75克OGTT。静脉血采集于两种不同的试管中。血浆葡萄糖在Cobas c701上进行测量，并在AccuChek Inform II上进行双份测量（两种方法均来自罗氏诊断公司）。通过参与具有参考方法指定值的外部对照程序来评估准确性。通过回归分析对所有样本（n = 512）的方法进行比较；斜率为0.90（95%CI：0.89 - 0.92），截距为0.12（95%CI：0.011 - 0.22），r为0.968。AccuChek Inform II与Cobas c701之间的平均偏差为 - 8%。基于AccuChek Inform II诊断为GDM的女性比例为25%，而基于Cobas c701为55%。外部对照程序的结果显示Cobas c701的偏差约为5%，AccuChek Inform II无显著偏差。Cobas c701对Accu - Chek Inform II和外部对照程序中使用的参考方法均显示出较大偏差，明显超过了<2.6%的理想偏差。准确性的缺乏对GDM的过度诊断或漏诊都有重大影响。
