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

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IMPACT FACTOR 2016: 3.432

CiteScore 2016: 2.21

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1437-4331
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Volume 53, Issue 11

Issues

Uncertainty in measurement for 43 biochemistry, immunoassay, and hemostasis routine analytes evaluated by a method using only external quality assessment data

Gladys Matar / Bernard Poggi
  • ProBioQual, Lyon, France
  • Service de Biochimie et Biologie moléculaire, Hôpital de la Croix-Rousse, Hospices Civils de Lyon, Lyon, France
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Roland Meley / Chantal Bon
  • ProBioQual, Lyon, France
  • Service de Biochimie et Biologie moléculaire, Hôpital de la Croix-Rousse, Hospices Civils de Lyon, Lyon, France
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Laurence Chardon
  • ProBioQual, Lyon, France
  • Service de Biochimie et Biologie moléculaire, Hôpital Edouard Herriot, Hospices Civils de Lyon, Lyon, France
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Karim Chikh
  • ProBioQual, Lyon, France
  • Service de Biochimie et Biologie moléculaire, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon, Pierre-Bénite, France
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Anne-Claude Renard / Catherine Sotta / Jean-Christophe Eynard / Regine Cartier
  • ProBioQual, Lyon, France
  • Service de Biochimie et Biologie moléculaire, Groupement Hospitalier Est, Hospices Civils de Lyon, Bron, France
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Richard Cohen
  • ProBioQual, Lyon, France
  • Service de Biochimie et Biologie moléculaire, Hôpital Edouard Herriot, Hospices Civils de Lyon, Lyon, France
  • Université Claude Bernard Lyon-1, ISPB Faculté de pharmacie, MATEIS UMR CNRS 5510, France
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
Published Online: 2015-03-26 | DOI: https://doi.org/10.1515/cclm-2014-0942

Abstract

Background: International organizations require from medical laboratories a quantitative statement of the uncertainty in measurement (UM) to help interpret patient results. The French accreditation body (COFRAC) recommends an approach (SH GTA 14 IQC/EQA method) using both internal quality control (IQC) and external quality assessment (EQA) data. The aim of this work was to validate an alternative way to quantify UM using only EQA results without any need for IQC data. This simple and practical method, which has already been described as the long-term evaluation of the UM (LTUM), is based on linear regression between data obtained by participants in EQA schemes and target values. We used it for 43 routine analytes covering biochemistry, immunoassay, and hemostasis fields.

Methods: Data from 50 laboratories participating in ProBioQual (PBQ) EQA schemes over 25 months were used to obtain estimates of the median and 90th percentile LTUM and to compare them to the usual analytical goals. Then, the two UM estimation methods were compared using data from 20 laboratories participating in both IQC and EQA schemes.

Results: Median LTUMs ranged from 2.9% (sodium) to 16.3% (bicarbonates) for biochemistry analytes, from 12.6% (prothrombin time) to 18.4% (factor V) for hemostasis analytes when using the mean of all participants, and were around 10% for immunoassays when using the peer-group mean. Median LTUMs were, in most cases, slightly lower than those obtained with the SH GTA 14 method, whatever the concentration level.

Conclusions: LTUM is a simple and convenient method that gives UM estimates that are reliable and comparable to those of recommended methods. Therefore, proficiency testing (PT) organizers are allowed to provide participants with an additional UM estimate using only EQA data and which could be updated at the end of each survey.

Keywords: external quality assessment; internal quality control; long-term analytical coefficient of variation; proficiency testing; uncertainty in measurement

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About the article

Corresponding author: Gladys Matar, ProBioQual, 9 rue Professeur Florence 69003, Lyon, France, E-mail:


Received: 2014-09-24

Accepted: 2015-02-19

Published Online: 2015-03-26

Published in Print: 2015-10-01


Citation Information: Clinical Chemistry and Laboratory Medicine (CCLM), Volume 53, Issue 11, Pages 1725–1736, ISSN (Online) 1437-4331, ISSN (Print) 1434-6621, DOI: https://doi.org/10.1515/cclm-2014-0942.

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