Dipartimento di Fisiopatologia Medico-Chirurgica e dei Trapianti, Centro per la Riferibilità Metrologica in Medicina di Laboratorio (CIRME), Università degli Studi di Milano, Via Fratelli Cervi 93, 20090, Segrate, Milan, Italy.
Istituto di Tecnologie Biomediche, Consiglio Nazionale delle Ricerche (ITB-CNR), Milan, Italy.
Acta Diabetol. 2020 Feb;57(2):215-219. doi: 10.1007/s00592-019-01408-4. Epub 2019 Aug 21.
Poor comparability between laboratory results may have a strong impact on clinical decisions. The aim of this study was to assess the quality of glucose and HbA measurements in a large cohort of laboratories in various countries, in order to evaluate whether the current state of these very basic laboratory examinations can be considered to be adequate with respect to the clinical needs in the management of glucose control in diabetic patients.
External quality assessment schemes and proficiency testing surveys performed in 2017 in several European and American laboratories were analyzed in order to estimate the percentage of laboratories reaching the desired quality criteria based on the allowable total error in accordance with various international recommendations.
In 2017 more than 95% of laboratories met the allowable total error for measuring HbA, and 92-94% of the studied laboratories met the target for glucose measurement.
The analytical quality for measuring glycated hemoglobin and glucose at laboratory level is generally acceptable, and accreditation to the ISO 15189:2012 standard is a robust guarantee that the laboratory meets the required criteria of acceptability. Several pre-analytical factors which may explain the discrepancies between the measured HbA and that estimated from other indicators of glucose control have to be taken into account, by focusing more on the pre-analytical than the analytical phase. In the case of glucose, special attention should be paid to the use of the correct anticoagulant, in order to avoid false negative results.
实验室结果的可比性差可能对临床决策产生重大影响。本研究旨在评估不同国家大量实验室的葡萄糖和 HbA 测量质量，以评估这些非常基础的实验室检查目前是否可以满足糖尿病患者血糖控制管理的临床需求。
分析了 2017 年在几个欧美实验室进行的外部质量评估计划和能力验证调查，以便根据各种国际建议，根据允许的总误差来估计达到理想质量标准的实验室比例。
2017 年，超过 95%的实验室达到了测量 HbA 的允许总误差，92-94%的研究实验室达到了测量葡萄糖的目标。
实验室水平测量糖化血红蛋白和葡萄糖的分析质量通常是可以接受的，符合 ISO 15189:2012 标准的认证是实验室符合可接受性要求的有力保证。需要考虑一些可能解释测量的 HbA 与其他血糖控制指标估计值之间差异的分析前因素，通过更关注分析前阶段而不是分析阶段。在葡萄糖的情况下，应特别注意使用正确的抗凝剂，以避免假阴性结果。
