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

Weykamp, Cas; John, W. Garry; English, Emma; Erasmus, Rajiv T; Sacks, David B.; Buchta, Christoph; Mueller, Mathias M.; Lenga, Yolande; Budina, Marek; Kratochvíla, Josef; Friedecký, B; Siest, Jean-Pascal; Kaiser, Patricia; Haliassos, Alexander; Panagiotakis, Otto; Makris, Konstantinos; Graham, Hazel; Kane, Anne; Smith, Thomas; Barrett, Edward J.; Sciacovelli, Laura; Plebani, Mario; Faria, Ana Andrade; Cardoso, Ana; Correia, Helena; Alemany, Montserrat Ventura; Alsina, Carmen Perich; Gómez, Carmen González; Nordin, Gunnar; Persson, Carita Krook; Fried, Roman; Akçadağ, Fatma; Akgöz, Müslüm; Aslan, Diler; Jones, Samantha; Thomas, Annette; Gillery, Philippe; Jaisson, Stéphane; Mosca, Andrea; Paleari, Renata; Slingerland, Robbert J.; Slootstra, Janine; Leppink, Sanne; Elmgren, Anders; Little, Randie R.; Connolly, Shawn; Makky, Vicky; Nowicki, Maren; Siebelder, Carla; Schröer-Janssen, Liesbeth; Winkel, Marieke te; Graaf, Irene De; Lenters-Westra, Erna

doi:10.1373/clinchem.2018.288795

Cited by 47 publications

(9 citation statements)

References 10 publications

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“…The first EurA1c trial included 2166 laboratories across 17 countries in Europe and covered methods made by 24 manufacturers. Each lab had to test the same two levels of HbA1c in either whole blood or lyophilised haemolysates [48]. This showed that, overall, the laboratories had low bias in their reporting.…”

Section: Diabetes Mellitusmentioning

confidence: 99%

Impact of Variation between Assays and Reference Intervals in the Diagnosis of Endocrine Disorders

Lorde,

Elgharably,

Kalaria

2023

Diagnostics

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Method-related variations in the measurement of hormones and the reference intervals used in the clinical laboratory can have a significant, but often under-appreciated, impact on the diagnosis and management of endocrine disorders. This variation in laboratory practice has the potential to lead to an errant approach to patient care and thus could cause harm. It may also be the source of confusion or result in excessive or inadequate investigation. It is important that laboratory professionals and clinicians know about these impacts, their sources, and how to detect and mitigate them when they do arise. In this review article, we describe the historical and scientific context from which inconsistency in the clinical laboratory arises. Examples from the published literature of the impact of the method, reference interval, and clinical decision threshold-related discordances on the assessment and monitoring of various endocrine disorders are discussed to illustrate the sources, causes, and effects of this variability. Its potential impact on the evaluation of growth hormone deficiency and excess, thyroid and parathyroid disorders, hyperandrogenism, hypogonadism, glucocorticoid excess and deficiency, and diabetes mellitus is elaborated. Strategies for assessment and mitigation of the discordance are discussed. The clinical laboratory has a responsibility to recognise and address these issues, and although a lot has been accomplished in this area already, there remains more to be done.

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Section: Diabetes Mellitusmentioning

confidence: 99%

Impact of Variation between Assays and Reference Intervals in the Diagnosis of Endocrine Disorders

Lorde,

Elgharably,

Kalaria

2023

Diagnostics

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“…The group favoured HbA 1c below the level currently used for initial diagnosis of diabetes, 48 mmol/mol (6.5%), and remaining at that level for at least 3 months without continuation of the usual antihyperglycaemic agents as the m a i n d e f i n i n g m e a s u r e m e n t . M e t h o d s u s e d t o measure HbA 1c must have stringent quality assurance in place and assays must be standardised to criteria aligned to international reference values [22][23][24].…”

Section: Glycaemic Criteria For Diagnosing Remission Of T2dmentioning

confidence: 99%

Consensus report: definition and interpretation of remission in type 2 diabetes

et al. 2021

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Improvement of glucose levels into the normal range can occur in some people living with diabetes, either spontaneously or after medical interventions, and in some cases can persist after withdrawal of glucose-lowering pharmacotherapy. Such sustained improvement may now be occurring more often due to newer forms of treatment. However, terminology for describing this process and objective measures for defining it are not well established, and the long-term risks vs benefits of its attainment are not well understood. To update prior discussions of this issue, an international expert group was convened by the American Diabetes Association to propose nomenclature and principles for data collection and analysis, with the goal of establishing a base of information to support future clinical guidance. This group proposed 'remission' as the most appropriate descriptive term, and HbA 1c <48 mmol/mol (6.5%) measured at least 3 months after cessation of glucose-lowering pharmacotherapy as the usual diagnostic criterion. The group also made suggestions for active observation of individuals experiencing a remission and discussed further questions and unmet needs regarding predictors and outcomes of remission. This Consensus Report is jointly published in The Journal of Clinical Endocrinology & Metabolism, published by Oxford University Press on behalf of the Endocrine Society; Diabetologia, published by Springer-Verlag, GmbH, on behalf of the European Association for the Study of Diabetes; Diabetic Medicine, published by Wiley on behalf of Diabetes UK; and Diabetes Care, published by the American Diabetes Association.A consensus report of a particular topic contains a comprehensive examination and is authored by an expert panel and represents the panel's collective analysis, evaluation and opinion. The article was reviewed for EASD by its Committee on Clinical Affairs.

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“…Der HbA 1c -Wert spiegelt die Blutzuckereinstellung der letzten 8 -12 Wochen wider [13]. [15,39]. Die HbA 1c -Werte sollen sowohl in der international gültigen SI-Einheit mmol/mol als auch in den abgeleiteten NGSP-Einheiten (NGSP: National Glycohemoglobin Standardization Program) in Prozent angegeben werden [16].…”

Section: Hba 1cunclassified

Labordiagnostik bei Diabetes mellitus

Hörber¹,

Schleicher²

2019

Diabetologie und Stoffwechsel

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Laboratory parameters are essential for diagnosis, prognosis and therapy control of diabetes mellitus. Diabetes-specific parameters including glucose, glycated hemoglobin (HbA1c), C-peptide and autoantibodies against beta cell epitopes as well as parameters of lipid metabolism and renal function should be taken into account. The precise and reliable determination of these parameters in accordance with the guidelines of the German Federal Medical Council for the determination of laboratory diagnostics is fundamental for the correct classification and evaluation of the measurement results. For this, important pre-analytical and analytical limitations must be considered.

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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

Cited by 47 publications

References 10 publications

Impact of Variation between Assays and Reference Intervals in the Diagnosis of Endocrine Disorders

Impact of Variation between Assays and Reference Intervals in the Diagnosis of Endocrine Disorders

Consensus report: definition and interpretation of remission in type 2 diabetes

Labordiagnostik bei Diabetes mellitus

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