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Defining age partitions for thyrotropin (TSH) reference intervals in infancy: a robust statistical approach.

Udara D Senarathne1, Zhong X Lu2, James C G Doery3

  • 1Department of Biochemistry, Faculty of Medical Sciences, University of Sri Jayewardenepura, Nugegoda, Sri Lanka; Department of Chemical Pathology, Monash Health Pathology, Monash Health, Melbourne, VIC, Australia; Department of Medicine, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, VIC, Australia.

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Summary

Establishing age-specific thyroid-stimulating hormone (TSH) reference intervals for infants is crucial for accurate diagnosis. This study defines new TSH reference ranges for the first year of life, improving thyroid disorder detection in neonates and infants.

Keywords:
Age partitioningBig data analyticsNon-parametric statisticsPaediatric endocrinologyReference intervalsThyroid function testsThyrotropin

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Area of Science:

  • Pediatric Endocrinology
  • Clinical Chemistry
  • Neonatal Medicine

Background:

  • Thyroid hormones are vital for infant growth and neurodevelopment.
  • Accurate interpretation of thyroid-stimulating hormone (TSH) requires age-specific reference intervals (RIs), which are currently ill-defined for the first year of life.
  • Diagnostic uncertainty and unnecessary testing arise from the lack of established pediatric TSH RIs.

Purpose of the Study:

  • To establish statistically derived age partitions for TSH RIs reflecting thyroid physiology in infants up to one year old.
  • To improve diagnostic accuracy for thyroid disorders in the pediatric population.
  • To provide a reproducible method for defining age-dependent analyte partitions.

Main Methods:

  • Retrospective analysis of de-identified TSH results from 11,045 infants at a tertiary hospital.
  • Exclusion of data from infants with repeat tests, extreme TSH values, or conditions affecting thyroid function.
  • Sequential application of the Mann-Whitney U test to identify age partitions, followed by validation using Lahti et al. criteria.

Main Results:

  • Five age partitions were identified: days 0-1, 2, 3, 4-89, and 90-365.
  • TSH levels peaked on days 0-1 (RI: 1.9-40.1 mIU/L), decreased sharply by day 2, and reached near-adult levels by days 90-365 (RI: 0.7-5.7 mIU/L).
  • No significant sex-based differences in TSH levels were observed.

Conclusions:

  • A robust, data-driven framework for age-specific TSH RIs in infants aged 0-365 days has been established.
  • The defined TSH RIs enhance diagnostic accuracy for infant thyroid disorders.
  • The methodology offers a reproducible approach for defining age-specific reference intervals for other analytes.