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Licensed Unlicensed Requires Authentication Published by De Gruyter May 12, 2016

HbA1c: EQA in Germany, Belgium and the Netherlands using fresh whole blood samples with target values assigned with the IFCC reference system

Patricia Kaiser, Michael Spannagl, Christel van Campenhout, Yolande Lenga, Carla Siebelder and Cas Weykamp

Abstract

Background:

External quality assessment/proficiency test (EQA/PT) organizers play an important role in monitoring the performance of HbA1c measurements. With increasing quality of the assays, HbA1c is increasingly used for diagnosis of diabetes and the demands on EQA/PT organizers themselves are rising constantly. EQA organizers in Germany (INSTAND), Belgium (WIV/IPV), and the Netherlands (SKML) organized a program with commutable samples and target values assigned with the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) reference system. The aim of this project was to confirm the logistic feasibility of organizing synchronically in the three countries, an accuracy-based EQA program with fresh whole blood, to investigate the performance of HbA1c assays within and across countries and manufacturers, and to review the EQA acceptance limits.

Methods:

Throughout 2015, ten fresh whole blood samples were supplied to the participants. Aggregated results were evaluated according to the IFCC model for quality targets at four levels: overall, per country, per manufacturer, and per country per manufacturer.

Results:

Robust results in summer and winter demonstrated the feasibility of organizing an EQA with fresh whole blood samples in three countries. The overall performances, as well as the performance for each country were very similar: results fell within the IFCC criteria. Although substantial differences between results from different manufacturers were present, the performances of laboratories using tests of the same manufacturer were strikingly similar in the three countries, suggesting that the quality of HbA1c assays is for the most part manufacturer- related. The improved design of the EQA program also suggested that acceptance limits for performance can be reduced to approximately 8%.


Corresponding author: Dr. Patricia Kaiser, INSTAND e.V., Reference Laboratory, Düsseldorf, Germany, Fax: +49 211 15921356

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

  2. Research funding: None declared.

  3. Employment or leadership: None declared.

  4. Honorarium: None declared.

  5. 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.

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Supplemental Material:

The online version of this article (DOI: 10.1515/cclm-2016-0123) offers supplementary material, available to authorized users.


Received: 2016-2-16
Accepted: 2016-4-7
Published Online: 2016-5-12
Published in Print: 2016-11-1

©2016 Walter de Gruyter GmbH, Berlin/Boston