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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

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 46, Issue 10

Issues

Analytical quality goals for parathyroid hormone based on biological variation

Adie Viljoen / Dhruv K. Singh / Patrick J. Twomey / Ken Farrington

Abstract

Background: Measurement of parathyroid hormone (PTH) is central in the investigation of pathologies of bone and mineral ion metabolism. Knowledge of the biological variation of an analyte forms an essential part of evaluating a new analyte, enabling the objective assessment of changes in serial results and the utility of reference intervals, as well as establishing laboratory quality specifications.

Methods: This study determined the biological variation of PTH in 20 healthy individuals, which was calculated according to the familiar methods outlined by Fraser and Harris.

Results: The within-subject variation was 25.3% and the between-subject variation was 43.4%. The critical difference for sequential values significant at p<0.05 was calculated as 72%. The within-subject variation forms a relatively small part of the reference interval, shown by the low index of individuality of 0.58. Objective analytical quality goals have also been established, revealing achievable optimum performance for imprecision of ∼6%. The desirable analytical bias goal was ∼12%.

Conclusions: This study has objectively shown that the analytical precision of current instruments is being achieved contrary to the known problems surrounding the analytical bias for PTH assays. The limitations of using reference intervals for PTH, both in diagnoses and monitoring, are shown.

Clin Chem Lab Med 2008;46:1438–42.

Keywords: biological variation; laboratory quality specifications; parathyroid hormone; reference change value

About the article

Corresponding author: Adie Viljoen, Department of Clinical Biochemistry, Lister Hospital, Stevenage, UK Phone: +44-1438-314333 ext. 5972, Fax: +44-1438-781147,


Received: 2008-04-03

Accepted: 2008-06-10

Published in Print: 2008-10-01


Citation Information: Clinical Chemistry and Laboratory Medicine, Volume 46, Issue 10, Pages 1438–1442, ISSN (Online) 1437-4331, ISSN (Print) 1434-6621, DOI: https://doi.org/10.1515/CCLM.2008.275.

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©2008 by Walter de Gruyter Berlin New York.Get Permission

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