Abstract
Aims
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 HbA1c 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.
Methods
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.
Results
In 2017 more than 95% of laboratories met the allowable total error for measuring HbA1c, and 92–94% of the studied laboratories met the target for glucose measurement.
Conclusions
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 HbA1c 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.
This is a preview of subscription content, log in via an institution to check access.
Similar content being viewed by others
References
Beastall GH (2013) Adding value to laboratory medicine: a professional responsibility. Clin Chem Lab Med 51:221–227
American Diabetes Association (2019) Classification and diagnosis of diabetes: standards of medical care in diabetes. Diabetes Care 42(Suppl. 1):S13–S28
Cohen RM, Holmes YR, Chenier TC et al (2003) Discordance between HbA1c and fructosamine: evidence for a glycosylation gap and its relation to diabetic nephropathy. Diabetes Care 26:163–167
Plebani M (2006) Errors in clinical laboratories or errors in laboratory medicine? Clin Chem Lab Med 44:750–759
EurA1c Trial Group (2018) EurA1c: the European HbA1c trial to investigate the performance of HbA1c assays in 2166 laboratories across 17 countries and 24 manufacturers by use of the IFCC model for quality targets. Clin Chem 64:1183–1192
www.ngsp.org/CAP/CAP17a.pdf. Accessed 27 May 2019
www.rfb.bio. Accessed 28 May 2019
Mosca A, Paleari R, Carobene A et al (2015) Performance of glycated hemoglobin (HbA1c) methods evaluated with EQAS studies using fresh blood samples: still space for improvements. Clin Chim Acta 451:305–309
González-Lao E, Corte Z, Simón M et al (2019) Systematic review of the biological variation data for diabetes related analytes. Clin Chim Acta 488:61–67
Società Italiana di Diabetologia (SID) e Associazione Medici Diabetologi (AMD) (2018) Standard italiani per la cura del diabete mellito I:5–15
Braga F, Dolci A, Montagnana M et al (2011) Revaluation of biological variation of glycated hemoglobin (HbA1c) using an accurately designed protocol and an assay traceable to the IFCC reference system. Clin Chim Acta 412:1412–1416
Bonetti G, Carta M, Lapolla A et al, on behalf of the SIBioC-SIPMeL Working group on Diabetes and the Italian Diabetes Society (SID) (2019) Correct determination of glycemia in the diagnosis and management of diabetes: recommendations for the optimization of the pre-analytical phase. Nutr Metab Cardiovasc Dis 29:1–3
Lapolla A, Mosca A, Fedele D (2011) The general use of glycated haemoglobin for the diagnosis of diabetes and other categories of glucose intolerance: Still a long way to go. Nutr Metab Cardiovasc 21:467–475
Sacks DB, Arnold M, Bakris GL et al (2011) Guidelines and recommendations for laboratory analysis in the diagnosis and management of diabetes mellitus. Clin Chem 57:e1–e47
https://www.iso.org/standard/56115.html. Accessed 25 May 2019
Acknowledgements
We acknowledge Prof. Riccardo Miccoli (Dip. Medicina Clinica e Sperimentale, Università degli Studi, Pisa, Italy) for the helpful discussion and suggestions. We also acknowledge Dr. Mario Cassani (Centro di Riferimento Regionale per la Qualità dei Servizi di Medicina di Laboratorio, Regione Lombardia, Italy) for having provided the data from the laboratories located in Lombardy.
Author information
Authors and Affiliations
Corresponding author
Ethics declarations
Conflict of interest
We have no conflict of interest disclosures as per the International Committee of Medical Journal Editors (ICMJE) guidelines.
Human and animal rights
This study is not based on clinical trials or animal studies.
Informed consent
For this type of study, formal consent is not required.
Additional information
Managed By Massimo Porta.
Publisher's Note
Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
Rights and permissions
About this article
Cite this article
Mosca, A., Quercioli, M. & Paleari, R. The analytical performance of laboratory plasma glucose and HbA1c measurements are largely acceptable. Acta Diabetol 57, 215–219 (2020). https://doi.org/10.1007/s00592-019-01408-4
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s00592-019-01408-4