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Clinical Chemistry and Laboratory Medicine (CCLM)

Published in Association with the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM)

Editor-in-Chief: Plebani, Mario

Ed. by Gillery, Philippe / Greaves, Ronda / Lackner, Karl J. / Lippi, Giuseppe / Melichar, Bohuslav / Payne, Deborah A. / Schlattmann, Peter


IMPACT FACTOR 2018: 3.638

CiteScore 2018: 2.44

SCImago Journal Rank (SJR) 2018: 1.191
Source Normalized Impact per Paper (SNIP) 2018: 1.205

Online
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1437-4331
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Volume 57, Issue 10

Issues

Trueness assessment of HbA1c routine assays: are processed EQA materials up to the job?

Vincent Delatour / Noémie Clouet-Foraison
  • Laboratoire National de Métrologie et d’Essais (LNE), Paris, France
  • University Hospital of Reims, Laboratory of Biochemistry, Reims, France
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Stéphane Jaisson / Patricia Kaiser / Philippe Gillery
Published Online: 2019-05-14 | DOI: https://doi.org/10.1515/cclm-2019-0219

Abstract

Background

With the worldwide increase of diabetes mellitus prevalence, ensuring that HbA1c assays are accurate is essential. External quality assessment (EQA) programs enable laboratories to verify that analytical methods perform according to the manufacturers’ specifications. However, assessing trueness requires commutable materials, a property that is rarely characterized for EQA materials.

Methods

The difference in bias approach was used to assess commutability of 26 processed quality control materials for 17 of the most frequently used HbA1c assays. Involved assays included immuno-assays, enzymatic assays, affinity, ion-exchange HPLC boronate affinity HPLC and capillary electrophoresis. The measurements were performed at manufacturers or expert laboratories. Assay trueness was additionally assessed against the IFCC reference measurement procedure using fresh clinical specimens that were distributed to 450 medical laboratories.

Results

Commutability of processed EQA materials was highly heterogeneous and globally insufficient to rigorously assess the trueness of HbA1c assays. Using fresh clinical specimens, mean bias was −0.13 mmol/mol for low HbA1c (34 mmol/mol), between +1.0 and +1.3 mmol/mol for intermediate HbA1c (49 and 58 mmol/mol) and +1.2 mmol/mol for elevated HbA1c (90 mmol/mol).

Conclusions

This study demonstrates that due to insufficient commutability, most processed EQA materials are unsuitable to assess trueness of HbA1c assays and agreement between the different assays. These materials can only provide information on comparability of individual laboratory results with its peers and on assay precision. Using fresh whole blood samples, this study additionally shows that most HbA1c assays are fairly accurate and meet the total allowable error quality target of 5 mmol/mol.

This article offers supplementary material which is provided at the end of the article.

Keywords: accuracy; accuracy-based program; commutability; comparability; external quality assessment schemes; glycated hemoglobin; HbA1c

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About the article

Corresponding author: Dr. Vincent Delatour, Laboratoire National de Métrologie et d’Essais (LNE), 1 rue Gaston Boissier, 75724 Paris Cedex 15, France, Phone: +33 140 434 075

aVincent Delatour and Noémie Clouet-Foraison contributed equally to the writing of this article.


Received: 2019-02-25

Accepted: 2019-04-07

Published Online: 2019-05-14

Published in Print: 2019-09-25


Author contributions: All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.

Research funding: None declared.

Employment or leadership: None declared.

Honorarium: None declared.

Competing interests: The funding organization(s) played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.


Citation Information: Clinical Chemistry and Laboratory Medicine (CCLM), Volume 57, Issue 10, Pages 1623–1631, ISSN (Online) 1437-4331, ISSN (Print) 1434-6621, DOI: https://doi.org/10.1515/cclm-2019-0219.

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