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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


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Volume 51, Issue 10

Issues

A systematic review of data on biological variation for alanine aminotransferase, aspartate aminotransferase and γ-glutamyl transferase

Anna Carobene
  • Corresponding author
  • Standardization Laboratory, Diagnostica e Ricerca San Raffaele S.p.A., via Olgettina 60, 20132 Milan, Italy
  • European Federation of Clinical Chemistry and Laboratory Medicine (EFLM), Working Group Biological Variation, www.efcclm.org
  • Email
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Federica Braga
  • Chair of Clinical Biochemistry and Clinical Molecular Biology, University of Milan Medical School, Milan, Italy
  • European Federation of Clinical Chemistry and Laboratory Medicine (EFLM), Working Group Biological Variation, www.efcclm.org
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Thomas Roraas
  • Norwegian Quality Improvement of Primary Care Laboratories (NOKLUS), Haraldsplass Hospital, Bergen, Norway
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Sverre Sandberg
  • Norwegian Quality Improvement of Primary Care Laboratories (NOKLUS), Haraldsplass Hospital, Bergen, Norway
  • Laboratory of Clinical Biochemistry, Haukeland University Hospital, Bergen, Norway
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ William A. Bartlett
  • Blood Sciences, Ninewells Hospital and Medical School Ninewells, Dundee, UK
  • European Federation of Clinical Chemistry and Laboratory Medicine (EFLM), Working Group Biological Variation, www.efcclm.org
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
Published Online: 2013-06-11 | DOI: https://doi.org/10.1515/cclm-2013-0096

Abstract

Background: Alanine aminotransferase (ALT), aspartate aminotransferase (AST) and γ-glutamyl transferase (GGT) are enzymes measured in serum or plasma to investigate liver disease. The aim of this work is to assess the validity of published biological variation (BV) data currently available for these enzymes.

Methods: Publications containing BV data for ALT, AST and GGT were identified by searching PubMed using the following keywords: biological varia*, RCV, CVw, CVi, CVb, and CVg. The 95% confidence intervals for the within- and between-subject coefficients of variation were calculated using the analytical imprecision, the number of subjects, samples and replicates.

Results: The searches identified 10 publications with ALT, 14 with AST and nine with GGT data. The protocols presented in those publications as used were varied. The ranges of within-subject variation reported were: ALT: 11.1%–58.1%, AST: 3.0%–32.3% and for GGT: 3.9%–14.5%. The median values (ALT: 18.0%, AST: 11.9% and GGT: 13.8%) were similar to those listed in a BV database commonly used as a reference source.

Conclusions: Published BV data for ALT, AST and GGT demonstrate a wide range of values derived from inconsistent protocols. The quality of the presentations of the data is variable. These findings raise concerns around the utility of the data currently available and highlight the need for critical appraisal of such publications. The working group on BV of the European Federation of Clinical Chemistry and Laboratory Medicine is undertaking work to develop a critical appraisal checklist for the production and publication of reliable BV data.

Keywords: biological variation; enzymes; quality specification; reference change value

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About the article

Corresponding author: Anna Carobene, Standardization Laboratory, Diagnostica e Ricerca San Raffaele S.p.A., via Olgettina 60, 20132 Milan, Italy, Phone: +39 2 26432850, Fax: +39 2 26434178, E-mail:


Received: 2013-02-05

Accepted: 2013-05-16

Published Online: 2013-06-11

Published in Print: 2013-10-01


Citation Information: Clinical Chemistry and Laboratory Medicine, Volume 51, Issue 10, Pages 1997–2007, ISSN (Online) 1437-4331, ISSN (Print) 1434-6621, DOI: https://doi.org/10.1515/cclm-2013-0096.

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