Spanish Society of Laboratory Medicine, Extra-analytical Quality Commission, Barcelona, Spain.
Area Laboratory, A Coruña University Hospital Complex, A Coruña, Spain.
Biochem Med (Zagreb). 2020 Feb 15;30(1):010704. doi: 10.11613/BM.2020.010704. Epub 2019 Dec 15.
Diabetes mellitus (DM) is one of the most prevalent diseases worldwide. The objective of this study was to find out under what preanalytical conditions routine and diagnostic glucose tests are performed across Spanish laboratories; and also what criteria are used for DM diagnosis.
An online survey was performed by the Commission on Quality Assurance in the Extra-Analytical Phase of the Spanish Society of Laboratory Medicine (SEQC-ML). Access to the questionnaire was available on the home page of the SEQC-ML website during the period April-July 2018. Data analysis was conducted with the IBM SPSS Statistics (version 20.0) program.
A total of 96 valid surveys were obtained. Most laboratories were in public ownership, serving hospital and primary care patients, with high and medium workloads, and a predominance of mixed routine-urgent glucose testing. Serum tubes were the most used for routine glucose analysis (92%) and DM diagnosis (54%); followed by lithium-heparin plasma tubes (62%), intended primarily for urgent glucose testing; point-of-care testing devices were used by 37%; and plasma tubes with a glycolysis inhibitor, mainly sodium fluoride, by 19%. Laboratories used the cut-off values and criteria recognized worldwide for DM diagnosis in adults and glucose-impaired tolerance, but diverged in terms of fasting plasma glucose and gestational DM criteria.
Preanalytical processing of routine and DM diagnostic glucose testing in Spain does not allow a significant, non-quantified influence of glycolysis on the results to be ruled out. Possible adverse consequences include a delay in diagnosis and possible under-treatment.
糖尿病(DM)是全球最常见的疾病之一。本研究旨在了解西班牙各实验室常规和诊断性血糖检测在何种分析前条件下进行,以及用于 DM 诊断的标准是什么。
西班牙临床化学和检验医学协会质量保证委员会在分析前阶段(SEQC-ML)进行了一项在线调查。在 2018 年 4 月至 7 月期间,SEQC-ML 网站主页上可以访问问卷。使用 IBM SPSS Statistics(版本 20.0)程序进行数据分析。
共获得 96 份有效调查。大多数实验室为公有制,服务于医院和初级保健患者,工作量大,常规-紧急血糖检测混合。血清管最常用于常规血糖分析(92%)和 DM 诊断(54%);其次是锂肝素血浆管(62%),主要用于紧急血糖检测;37%使用即时检测设备;19%使用含有糖酵解抑制剂(主要是氟化钠)的血浆管。实验室使用了全世界公认的成人和葡萄糖耐量受损的 DM 诊断的截止值和标准,但在空腹血糖和妊娠期 DM 标准方面存在差异。
西班牙常规和 DM 诊断性血糖检测的分析前处理不能排除糖酵解对结果的显著、非量化影响。可能产生的不良后果包括诊断延迟和可能的治疗不足。