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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.

12 Issues per year


IMPACT FACTOR 2016: 3.432

CiteScore 2016: 2.21

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Source Normalized Impact per Paper (SNIP) 2016: 1.112

Online
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1437-4331
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Volume 49, Issue 4 (Apr 2011)

Issues

Do new concepts for deriving permissible limits for analytical imprecision and bias have any advantages over existing consensus?

Per Hyltoft Petersen
  • NOKLUS, Norwegian Quality Improvement of Primary Care Laboratories, Division for General Practice, University of Bergen, Bergen, Norway
  • Postal address: Flittig Lise Vej 20, 5250 Odense SV, Denmark.
  • Email
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Sverre Sandberg
  • NOKLUS, Norwegian Quality Improvement of Primary Care Laboratories, Division for General Practice, University of Bergen, Bergen, Norway
  • Laboratory of Clinical Biochemistry, Haukeland University Hospital, Bergen, Norway
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Callum G. Fraser
Published Online: 2011-02-11 | DOI: https://doi.org/10.1515/CCLM.2011.117

Abstract

The Stockholm conference held in 1999 on “Strategies to set global analytical quality specifications (AQS) in laboratory medicine” reached a consensus and advocated the ubiquitous application of a hierarchical structure of approaches to setting AQS. This approach has been widely used over the last decade, although several issues remain unanswered. A number of new suggestions have been recently proposed for setting AQS. One of these recommendations is described by Haeckel and Wosniok in this issue of Clinical Chemistry and Laboratory Medicine. Their concept is to estimate the increase in false-positive results using conventional population-based reference intervals, the delta false-positive rate due to analytical imprecision and bias, and relate the results directly to the current analytical quality attained. Thus, the actual estimates in the laboratory for imprecision and bias are compared to the AQS. These values are classified in a ranking system according to the closeness to the AQS, and this combination is the new idea of the proposal. Other new ideas have been proposed recently. We wait, with great interest, as should others, to see if these newer approaches become widely used and worthy of incorporation into the hierarchy.

Keywords: analytical goals; analytical quality specifications; biological variation; clinical situations; hierarchy of specifications; medical opinions

About the article

Corresponding author: Per Hyltoft Petersen, NOKLUS, Norwegian Quality Improvement of Primary Care Laboratories, Division for General Practice, University of Bergen, Bergen, Norway Phone: +45-65-962565


Received: 2010-11-24

Accepted: 2010-11-24

Published Online: 2011-02-11

Published in Print: 2011-04-01


Citation Information: Clinical Chemistry and Laboratory Medicine, ISSN (Online) 1437-4331, ISSN (Print) 1434-6621, DOI: https://doi.org/10.1515/CCLM.2011.117.

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©2011 by Walter de Gruyter Berlin New York. Copyright Clearance Center

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