Jump to ContentJump to Main Navigation
Show Summary Details
More options …

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 / Lackner, Karl J. / Lippi, Giuseppe / Melichar, Bohuslav / Payne, Deborah A. / Schlattmann, Peter


IMPACT FACTOR 2017: 3.556

CiteScore 2017: 2.34

SCImago Journal Rank (SJR) 2017: 1.114
Source Normalized Impact per Paper (SNIP) 2017: 1.188

Online
ISSN
1437-4331
See all formats and pricing
More options …
Volume 50, Issue 10

Issues

First evaluation of Capillarys 2 Flex Piercing® (Sebia) as a new analyzer for HbA1c assay by capillary electrophoresis

Stéphane Jaisson
  • Corresponding author
  • Laboratory of Paediatric Biology and Research, American Memorial Hospital, University Hospital of Reims, Reims, France
  • Email
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Nathalie Leroy
  • Laboratory of Paediatric Biology and Research, American Memorial Hospital, University Hospital of Reims, Reims, France
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Julie Meurice
  • Laboratory of Paediatric Biology and Research, American Memorial Hospital, University Hospital of Reims, Reims, France
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Emmanuelle Guillard
  • Laboratory of Paediatric Biology and Research, American Memorial Hospital, University Hospital of Reims, Reims, France
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Philippe Gillery
  • Laboratory of Paediatric Biology and Research, American Memorial Hospital, University Hospital of Reims, Reims, France
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
Published Online: 2012-04-26 | DOI: https://doi.org/10.1515/cclm-2012-0017

Abstract

Background: HbA1c is a key biomarker for the monitoring of glycemic balance in diabetic patients. It may be measured by various methods, including HPLC and immunoassays. Here we report the results of the first evaluation of Capillarys 2 Flex Piercing®, a new analyzer using capillary electrophoresis for the separation and the quantification of HbA1c.

Methods: We have evaluated the analytical performances of the method as well as the influence of the most frequent analytical interferences regarding HbA1c assays (i.e., labile HbA1c, carbamylated hemoglobin, high HbF and hemoglobin variants).

Results: Intra-assay and between-assays CVs were respectively lower than 1.98% and 2.68% on the pre-market version of the instrument, and lower than 1.62% and 1.45% on the commercial version. The linearity was excellent for HbA1c values ranging from 19 mmol/mol (3.9%) to 161 mmol/mol (16.9%) (r=0.999). The results were well correlated with those obtained by the HPLC method routinely used in the laboratory (Variant II® NU Kit – Bio-Rad): HbA1c[Capillarys 2]=0.9452×HbA1c[Variant II]+1.7279 (r=0.994, n=500). The use of titrated quality control samples indicated a good accuracy of the method. Neither the presence of HbF (until 15%), labile HbA1c or carbamylated hemoglobin, nor that of some typical hemoglobin variants, such as hemoglobin S, D, C and E, affected HbA1c measurement.

Conclusions: This evaluation showed that the analytical performances of Capillarys 2 Flex Piercing® analyzer for HbA1c assay fulfilled quality criteria requested for clinical use, and allowed to recommend its implementation in clinical chemistry laboratories for routine practice.

Keywords: capillary electrophoresis; diabetes; HbA1c; HPLC

About the article

Corresponding author: Dr. Stéphane Jaisson, Laboratoire de Biologie et de Recherche, Pédiatriques, American Memorial Hospital, CHU de Reims, 47 rue Cognacq-Jay, 51092 Reims Cedex, France Phone: +33 3 26787562, Fax: +33 3 26783882


Received: 2012-01-11

Accepted: 2012-04-05

Published Online: 2012-04-26

Published in Print: 2012-10-01


Citation Information: Clinical Chemistry and Laboratory Medicine, Volume 50, Issue 10, Pages 1769–1775, ISSN (Online) 1437-4331, ISSN (Print) 1434-6621, DOI: https://doi.org/10.1515/cclm-2012-0017.

Export Citation

©2012 by Walter de Gruyter Berlin Boston.Get Permission

Citing Articles

Here you can find all Crossref-listed publications in which this article is cited. If you would like to receive automatic email messages as soon as this article is cited in other publications, simply activate the “Citation Alert” on the top of this page.

[1]
Emma English and Erna Lenters-Westra
Critical Reviews in Clinical Laboratory Sciences, 2018, Page 1
[2]
Olivier Heylen, Stefaan Van Neyghem, Sandra Exterbille, Charline Wehlou, Frans Gorus, and Ilse Weets
American Journal of Clinical Pathology, 2014, Volume 141, Number 6, Page 867
[3]
Andrea Tesija Kuna, Kristina Dukic, Nora Nikolac Gabaj, Marijana Miler, Ines Vukasovic, Sanja Langer, Ana-Maria Simundic, and Nada Vrkic
Laboratory Medicine, 2018
[4]
[6]
Olav Klingenberg, Torill Furuset, Camilla R. Hestbråten, Marit H. Hallberg, Astrid Steiro, Iren R. Orset, and Jens P. Berg
Scandinavian Journal of Clinical and Laboratory Investigation, 2017, Page 1
[7]
Aurore Desmons, Stéphane Jaisson, Nathalie Leroy, Philippe Gillery, and Emmanuelle Guillard
Biochemia Medica, 2017, Volume 27, Number 2, Page 378
[8]
Radhouene Doggui, Chaïma Abdelhafidh Sahli, Wassef Lotfi Aissa, Maroua Hammami, Maha Ben Sedrine, Rahma Mahjoub, Khemais Zouaoui, Rim Daboubi, Hajer Siala, Taieb Messaoud, and Amina Bibi
ELECTROPHORESIS, 2017
[9]
Juan A. Orts, Ángel Zúñiga, Yanis Bello, Aleix B. Fabregat, and Ana I. Vicente
Hemoglobin, 2016, Volume 40, Number 5, Page 335
[10]
Valéry Brunel, Patrick Caneiro, Agnès Lahary, Guy Hue, and Christian Thuillez
Annals of Laboratory Medicine, 2016, Volume 36, Number 4, Page 375
[11]
Samya Bekri, Laurent Leclercq, and Hervé Cottet
Journal of Chromatography A, 2016, Volume 1432, Page 145
[13]
Philippe Gillery
Clinical Chemistry and Laboratory Medicine (CCLM), 2015, Volume 53, Number 9
[14]
Ling Ji, Jing Yu, Yu Zhou, Yong Xia, Anping Xu, Weining Li, and Lu Li
Clinical Chemistry and Laboratory Medicine (CCLM), 2015, Volume 53, Number 9
[15]
Arjoanna Azizi, Pavai Sthaneshwar, Hemalatha Shanmugam, and Shanmuganathan Arumugam
Pathology, 2015, Volume 47, Number 5, Page 495
[16]
Prathibha R. Gajjala, Danilo Fliser, Thimoteus Speer, Vera Jankowski, and Joachim Jankowski
Nephrology Dialysis Transplantation, 2015, Volume 30, Number 11, Page 1814
[17]
Zhen Zhao, Jeffrey Basilio, Steven Hanson, Randie R. Little, Anne E. Sumner, and David B. Sacks
Clinica Chimica Acta, 2015, Volume 446, Page 54
[18]
Xinqi Cheng, Ming Li, Jie Wu, and Wei Su
Clinica Chimica Acta, 2015, Volume 444, Page 163
[19]
Julien Wils, Patrick Caneiro, Ludivine Lebourg, Agnès Lahary, Abdeslam Chagraoui, and Valéry Brunel
Clinica Chimica Acta, 2015, Volume 440, Page 6
[20]
Stéphane Jaisson, Aurore Desmons, Benoît Renard, Benjamin Chevelle, Nathalie Leroy, and Philippe Gillery
Clinica Chimica Acta, 2014, Volume 434, Page 48
[21]
Mariarita Dessi, Massimo Pieri, Stefano Pignalosa, Francesca Gabriela Martino, and Rossella Zenobi
Journal of Clinical Laboratory Analysis, 2015, Volume 29, Number 1, Page 57
[22]
P. Gillery
Médecine des Maladies Métaboliques, 2013, Volume 7, Number 3, Page 256
[23]
Cas Weykamp
Annals of Laboratory Medicine, 2013, Volume 33, Number 6, Page 393
[24]
María L. González-Borrachero, Paloma Ropero-Gradilla, José M. Vergara-Chozas, and Fernando A. González-Fernández
Clinica Chimica Acta, 2013, Volume 425, Page 160
[25]
Mariela Marinova, Sara Altinier, Anna Caldini, Gabriella Passerini, Giorgio Pizzagalli, Marco Brogi, Martina Zaninotto, Ferruccio Ceriotti, and Mario Plebani
Clinica Chimica Acta, 2013, Volume 424, Page 207
[26]
S. Jaisson, N. Leroy, C. Desroches, M. Tonye-Libyh, E. Guillard, and P. Gillery
Diabetes & Metabolism, 2013, Volume 39, Number 4, Page 363

Comments (0)

Please log in or register to comment.
Log in