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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 2017: 3.556

CiteScore 2018: 2.44

SCImago Journal Rank (SJR) 2018: 1.191
Source Normalized Impact per Paper (SNIP) 2018: 1.205

Online
ISSN
1437-4331
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Volume 49, Issue 7

Issues

Towards more complete specifications for acceptable analytical performance – a plea for error grid analysis

Jan S. Krouwer / George S. Cembrowski
Published Online: 2011-05-27 | DOI: https://doi.org/10.1515/CCLM.2011.610

Abstract

We examine limitations of common analytical performance specifications for quantitative assays. Specifications can be either clinical or regulatory. Problems with current specifications include specifying limits for only 95% of the results, having only one set of limits that demarcate no harm from minor harm, using incomplete models for total error, not accounting for the potential of user error, and not supplying sufficient protocol requirements. Error grids are recommended to address these problems as error grids account for 100% of the data and stratify errors into different severity categories. Total error estimation from a method comparison can be used to estimate the inner region of an error grid, but the outer region needs to be addressed using risk management techniques. The risk management steps, foreign to many in laboratory medicine, are outlined.

Keywords: error grids; FMEA; FRACAS; specifications; total error

About the article

Corresponding author: Jan S. Krouwer, Krouwer Consulting, 26 Parks Drive, Sherborn, MA 01770, USA Phone: +1-508-653-2379, Fax: +1-508-653-2379


Published Online: 2011-05-27

Published in Print: 2011-07-01


Citation Information: Clinical Chemistry and Laboratory Medicine, Volume 49, Issue 7, Pages 1127–1130, ISSN (Online) 1437-4331, ISSN (Print) 1434-6621, DOI: https://doi.org/10.1515/CCLM.2011.610.

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