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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

Editorial Board Member: Gillery, Philippe / Kazmierczak, Steven / Lackner, Karl J. / Lippi, Giuseppe / Melichar, Bohuslav / Schlattmann, Peter / Whitfield, John B.

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Establishment of reference distributions and decision values for thyroid antibodies against thyroid peroxidase (TPOAb), thyroglobulin (TgAb) and the thyrotropin receptor (TRAb)

Esther A. Jensen1 / Per Hyltoft Petersen2 / Ole Blaabjerg3 / Pia Skov Hansen4 / Thomas H. Brix5 / Laszlo Hegedüs6

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Corresponding author: Esther A. Jensen, Department of Clinical Biochemistry, Odense University Hospital, 5000 Odense C, Denmark Phone: +45-65-412865, Fax: +45-65-411911,

Citation Information: Clinical Chemical Laboratory Medicine. Volume 44, Issue 8, Pages 991–998, ISSN (Online) 1437-4331, ISSN (Print) 1434-6621, DOI: 10.1515/CCLM.2006.166, July 2006

Publication History

Received:
February 16, 2006
Accepted:
May 3, 2006
Published Online:
2006-07-31

Abstract

Background: The National Academy of Clinical Biochemistry (NACB) stresses that the reference intervals for thyroid peroxidase antibodies (TPOAb), thyroglobulin antibodies (TgAb) and thyroid stimulating hormone (TSH)-receptor antibodies (TRAb) should be based on young men who lack certain risk factors and have serum TSH between 0.5 and 2.0 mIU/L. However, some young men without any of the risk factors have autoantibodies, and cannot be identified by the present tools. A model for reference intervals and cut-off values should not be influenced by the prevalence of risk factors.

Methods: We developed a model of “composite logarithmic Gaussian distributions” and tested it in 1441 well-characterised subjects without clinically overt thyroid disease.

Results: TPOAb and TgAb could be measured in all individuals. The 97.5% upper limits 1) on a traditional non-parametric scale, 2) according to the NACB criteria, and 3) for our model were 284, 24 and 9.8 kIU/L for TPOAb, and 84, 22 and 19 kIU/L for TgAb, respectively. The decision value (defined as the concentration corresponding to 0.1% false positives) was 15 kIU/L for TPOAb and 31 kIU/L for TgAb. Concentrations above our reference intervals affected the corresponding distribution of TSH values. For TRAb the upper reference limits were 1) 0.75 and 2) 0.75 IU/L, while our model was not applicable to TRAb because only 2–3% of the results were above the functional assay sensitivity.

Conclusions: In contrast to the NACB guidelines, our model for TPOAb and TgAb is more robust, as it is independent of the characteristics of the reference population.

Clin Chem Lab Med 2006;44:991–8.

Keywords: composite distributions; ln-Gaussian distributions; models; NACB guidelines; rankit plot; reference interval; thyroid antibodies; thyroid hormones

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