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Impact of the reference values on the clinically-relevant cut-offs. The example of cortisol testing in children

Julie Brossaud1, Pascal Barat, Agnès Georges

  • 1Department of Nuclear Medicine, University Hospital, Bordeaux, France.

Clinical Chemistry and Laboratory Medicine
|May 26, 2012
PubMed

Insights

Pediatric cortisol reference ranges need local validation. Using manufacturer ranges may lead to misdiagnosis of adrenal insufficiency in children, impacting patient care.

Area of Science:

  • Pediatric Endocrinology
  • Clinical Chemistry
  • Assay Validation

Background:

  • Routine cortisol assay modification prompted re-evaluation of pediatric reference ranges.
  • Concerns arose regarding the accuracy of manufacturer-provided normal ranges for basal and stimulated cortisol levels in children.

Purpose of the Study:

  • To assess the clinical relevance of manufacturer-defined reference ranges for basal cortisol in children.
  • To evaluate the impact of these ranges on diagnosing adrenal insufficiency after glucagon-betaxolol testing.

Main Methods:

  • Retrospective analysis of basal and stimulated cortisol plasma concentrations in pediatric subjects.
  • Comparison of results obtained with a modified assay against manufacturer's reference ranges.
  • Investigation of a proposed 403 nmol/L specificity threshold for adrenal insufficiency.

Main Results:

  • 26% of children had "low" basal cortisol using the manufacturer's range.
  • A 403 nmol/L threshold indicated 31% adrenal insufficiency in apparently healthy children.
  • Prior radioimmunoassay (RIA) results showed lower values, with the threshold yielding only 5% false positives.

Conclusions:

  • Laboratories must establish population-specific reference values for hormone assays.
  • Failure to use validated ranges risks both false-positive and false-negative diagnostic outcomes.
  • Accurate reference ranges are critical for reliable diagnosis of pediatric endocrine disorders.
Abstract

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