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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

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1437-4331
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Volume 53, Issue 2

Issues

Biological variation database: structure and criteria used for generation and update

Carmen Perich
  • Spanish Society of Clinical Biochemistry and Molecular Pathology (SEQC), Analytical Quality Commission, Barcelona, Spain
  • Laboratoris Clínics, Hospital Vall d’Hebron, Barcelona, Spain
  • Other articles by this author:
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/ Joana Minchinela
  • Spanish Society of Clinical Biochemistry and Molecular Pathology (SEQC), Analytical Quality Commission, Barcelona, Spain
  • Laboratori Clínic, Barcelonès Nord i Vallès Oriental, Badalona, Spain
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Carmen Ricós
  • Corresponding author
  • Spanish Society of Clinical Biochemistry and Molecular Pathology (SEQC), Analytical Quality Commission, Barcelona, Spain
  • Email
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/ Pilar Fernández-Calle
  • Spanish Society of Clinical Biochemistry and Molecular Pathology (SEQC), Analytical Quality Commission, Barcelona, Spain
  • Hospital Universitario La Paz, Madrid, Spain
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  • De Gruyter OnlineGoogle Scholar
/ Virtudes Alvarez
  • Spanish Society of Clinical Biochemistry and Molecular Pathology (SEQC), Analytical Quality Commission, Barcelona, Spain
  • Laboratori Clínic, L’Hospitalet, Hospitalet de Llobregat, Spain
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/ María Vicenta Doménech
  • Spanish Society of Clinical Biochemistry and Molecular Pathology (SEQC), Analytical Quality Commission, Barcelona, Spain
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/ Margarita Simón
  • Spanish Society of Clinical Biochemistry and Molecular Pathology (SEQC), Analytical Quality Commission, Barcelona, Spain
  • Consorci del Laboratori Intercomarcal de l’Alt Penedès, l’Anoia i el Garraf, Barcelona, Spain
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/ Carmen Biosca
  • Spanish Society of Clinical Biochemistry and Molecular Pathology (SEQC), Analytical Quality Commission, Barcelona, Spain
  • Hospital GermansTrias i Pujol, Badalona, Spain
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/ Beatriz Boned
  • Spanish Society of Clinical Biochemistry and Molecular Pathology (SEQC), Analytical Quality Commission, Barcelona, Spain
  • Hospital Royo Villanova, Zaragoza, Spain
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/ José Vicente García-Lario
  • Spanish Society of Clinical Biochemistry and Molecular Pathology (SEQC), Analytical Quality Commission, Barcelona, Spain
  • Hospital Universitario Virgen de las Nieves, Granada, Spain
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/ Fernando Cava
  • Spanish Society of Clinical Biochemistry and Molecular Pathology (SEQC), Analytical Quality Commission, Barcelona, Spain
  • Laboratorio Clínico BR Salud, Hospital Infanta Sofía.San Sebastián de los Reyes, Madrid, Spain
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/ Pilar Fernández-Fernández
  • Spanish Society of Clinical Biochemistry and Molecular Pathology (SEQC), Analytical Quality Commission, Barcelona, Spain
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/ Callum G. Fraser
  • Spanish Society of Clinical Biochemistry and Molecular Pathology (SEQC), Analytical Quality Commission, Barcelona, Spain
  • Centre for Research into Cancer Prevention and Screening, University of Dundee, Dundee, Scotland, UK
  • Other articles by this author:
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Published Online: 2014-11-21 | DOI: https://doi.org/10.1515/cclm-2014-0739

Abstract

Background: Numerical data on the components of biological variation (BV) have many uses in laboratory medicine, including in the setting of analytical quality specifications, generation of reference change values and assessment of the utility of conventional reference values.

Methods: Generation of a series of up-to-date comprehensive database of components of BV was initiated in 1997, integrating the more relevant information found in publications concerning BV. A scoring system was designed to evaluate the robustness of the data included. The database has been updated every 2 years, made available on the Internet and derived analytical quality specifications for imprecision, bias and total allowable error included in the tabulation of data.

Results and conclusions: Our aim here is to document, in detail, the methodology we used to evaluate the reliability of the included data compiled from the published literature. To date, our approach has not been explicitly documented, although the principles have been presented at many symposia, courses and conferences.

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

Keywords: biological variation; quality specifications; reference change values; reference intervals

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About the article

Corresponding author: Dra. Carmen Ricós, Spanish Society of Clinical Biochemistry and Molecular Pathology (SEQC), Analytical Quality Commission, Plaza Gala Placidia 2, Barcelona, Spain, E-mail:


Received: 2014-07-17

Accepted: 2014-09-29

Published Online: 2014-11-21

Published in Print: 2015-02-01


Citation Information: Clinical Chemistry and Laboratory Medicine (CCLM), Volume 53, Issue 2, Pages 299–305, ISSN (Online) 1437-4331, ISSN (Print) 1434-6621, DOI: https://doi.org/10.1515/cclm-2014-0739.

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