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 Targetsстатья из журнала
Аннотация: Abstract BACKGROUND A major objective of the IFCC Committee on Education and Use of Biomarkers in Diabetes is to generate awareness and improvement of HbA1c assays through evaluation of the performance by countries and manufacturers. METHODS Fresh whole blood and lyophilized hemolysate specimens manufactured from the same pool were used by 17 external quality assessment organizers to evaluate analytical performance of 2166 laboratories. Results were evaluated per country, per manufacturer, and per manufacturer and country combined according to criteria of the IFCC model for quality targets. RESULTS At the country level with fresh whole blood specimens, 6 countries met the IFCC criterion, 2 did not, and 2 were borderline. With lyophilized hemolysates, 5 countries met the criterion, 2 did not, and 3 were borderline. At the manufacturer level using fresh whole blood specimens, 13 manufacturers met the criterion, 8 did not, and 3 were borderline. Using lyophilized hemolysates, 7 manufacturers met the criterion, 6 did not, and 3 were borderline. In both country and manufacturer groups, the major contribution to total error derived from between-laboratory variation. There were no substantial differences in performance between groups using fresh whole blood or lyophilized hemolysate samples. CONCLUSIONS The state of the art is that 1 of 20 laboratories does not meet the IFCC criterion, but there are substantial differences between country and between manufacturer groups. Efforts to further improve quality should focus on reducing between-laboratory variation. With some limitations, fresh whole blood and well-defined lyophilized specimens are suitable for purpose.
Год издания: 2018
Авторы: Cas Weykamp, W. Garry John, Emma English, Rajiv T Erasmus, David B. Sacks, Christoph Buchta, Maerit-Martha Mueller, Yolande Lenga, Marek Budina, Josef Kratochvíla, B Friedecký, Jean-Pascal Siest, Patricia Kaiser, Alexander Haliassos, Otto Panagiotakis, Konstantinos Makris, Hazel Graham, Anne Kane, Thomas P Smith, Edward J. Barrett, Laura Sciacovelli, Mario Plebani, Ana Andrade Faria, Ana Cardoso, Helena Correia, Montserrat Ventura Alemany, Carmen Perich Alsina, Carmen González Gómez, Gunnar Nordin, Carita Krook Persson, Roman Fried, Fatma Akçadağ, Müslüm Akgöz, Diler Aslan, Samantha Jones, Annette Thomas, Philippe Gillery, Stéphane Jaisson, Andrea Mosca, Renata Paleari, Robbert J. Slingerland, Janine Slootstra, Sanne Leppink, Anders Elmgren, Randie R. Little, Shawn Connolly, Vicky Makky, M. Nowicki, Carla Siebelder, Liesbeth Schröer-Janssen, Marieke te Winkel, Irene de Graaf, Erna Lenters-Westra
Издательство: American Association for Clinical Chemistry
Источник: Clinical Chemistry
Ключевые слова: Diabetes Management and Research, Statistical Methods in Clinical Trials, Diabetes Treatment and Management
Другие ссылки: Clinical Chemistry (PDF)
Clinical Chemistry (HTML)
UEA Digital Repository (University of East Anglia) (HTML)
PubMed (HTML)
Clinical Chemistry (HTML)
UEA Digital Repository (University of East Anglia) (HTML)
PubMed (HTML)
Открытый доступ: bronze
Том: 64
Выпуск: 8
Страницы: 1183–1192