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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. Jensen , Per Hyltoft Petersen , Ole Blaabjerg , Pia Skov Hansen , Thomas H. Brix and Laszlo Hegedüs
Published/Copyright: July 31, 2006

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 2.0mIU/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 9.8kIU/L for TPOAb, and 84, 22 and 19kIU/L for TgAb, respectively. The decision value (defined as the concentration corresponding to 0.1% false positives) was 15kIU/L for TPOAb and 31kIU/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) 0.75IU/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.


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

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Received: 2006-2-16
Accepted: 2006-5-3
Published Online: 2006-7-31
Published in Print: 2006-8-1

©2006 by Walter de Gruyter Berlin New York

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