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Rates of adrenal insufficiency using a monoclonal vs. polyclonal cortisol assay

  • Kyle P. McNerney ORCID logo EMAIL logo and Ana Maria Arbeláez
Published/Copyright: December 13, 2021
Journal of Pediatric Endocrinology and Metabolism
From the journal Journal of Pediatric Endocrinology and Metabolism Volume 35 Issue 3

Abstract

Objectives

The diagnosis of adrenal insufficiency relies on clear cut-offs and accurate measurement of cortisol levels. Newer monoclonal antibody assays may increase the rate of diagnosis of adrenal insufficiency if traditional cortisol cut-off levels <18 mcg/dL (500 nmol/L) are applied. We aimed to determine if the rate of diagnosis of adrenal insufficiency using a 1 mcg Cosyntropin stimulation test varied with the change in cortisol assay from a polyclonal to a monoclonal antibody assay.

Methods

Cortisol levels obtained during the 1 mcg Cosyntropin stimulation test performed in the last semester of 2016 using a polyclonal antibody cortisol assay were compared to tests performed using a monoclonal antibody cortisol assay during the first semester of 2017. Cosyntropin tests included cortisol values obtained at baseline, 20 min and 30 min after IV administration of 1 mcg Cosyntropin. Peak cortisol cut-off value <18 mcg/dL was used to diagnose adrenal insufficiency.

Results

Stimulated cortisol values after 1 mcg Cosyntropin using the monoclonal assay in 2017 (n=38) were significantly lower (33%) compared to those obtained with the polyclonal assay in 2016 (n=27) (p-value <0.001). The number of passing tests with a peak cortisol value >18 mcg/dL fell from 74% in 2016 (20 out of 27 tests) to 29% in 2017 (11 out of 38 tests).

Conclusions

The change in cortisol assay substantially increased the number of patients diagnosed with adrenal insufficiency after 1 mcg Cosyntropin stimulation testing. Standardization of cortisol assays and diagnostic criteria is critical for the accurate diagnosis of adrenal insufficiency.

Keywords: adrenal insufficiency; cortisol; cut-off levels; steroid analysis
Corresponding author: Kyle P. McNerney, MD, Department of Pediatrics, Division of Endocrinology, Diabetes, and Metabolism, Washington University School of Medicine/Saint Louis Children’s Hospital, One Children’s Place, Saint Louis, MO, 63310, USA, Phone: +314 454 6051, Fax: +314 454 6225, E-mail:

Funding source: Washington University in St. Louis

Award Identifier / Grant number: T32 Diabetes and Metabolism Training Grant

  1. Research funding: This work was supported by the Washington University in St Louis School of Medicine T32 Diabetes and Metabolism Training Grant.

  2. Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved its submission.

  3. Competing interests: Authors state no conflict of interest.

  4. Informed consent: Data collection was exempt from written consent of the participants and was approved by the IRB/Human Research Protection Office at Washington University in Saint Louis (IRB ID #: 202012130).

  5. Ethical approval: The research related to human use has been complied with all the relevant national regulations, institutional policies and in accordance the tenets of the Helsinki Declaration, and has been approved by the authors’ institutional review board or equivalent committee.

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Received: 2021-08-04
Accepted: 2021-11-22
Published Online: 2021-12-13
Published in Print: 2022-03-28

© 2021 Walter de Gruyter GmbH, Berlin/Boston

Articles in the same Issue

  1. Frontmatter
  2. Review Article
  3. Congenital hyperinsulinism: recent updates on molecular mechanisms, diagnosis and management
  4. Original Articles
  5. Weight changes of children in 1 year during COVID-19 pandemic
  6. Three novel mutations of the BCKDHA, BCKDHB and DBT genes in Chinese children with maple syrup urine disease
  7. Rates of adrenal insufficiency using a monoclonal vs. polyclonal cortisol assay
  8. Hyperinsulinemic hypoglycemia in growth restricted convalescent preterm neonates: clinical characteristics and impediments to early diagnosis
  9. Identification of three novel pathogenic mutations in cystathionine beta-synthase gene of Pakistani intellectually disabled patients
  10. The prevalence of incidental finding of gynecomastia on thoracic computed tomography in the pediatric age group
  11. The prevalence of hypertension and elevated blood pressure and its correlation with overweight/obesity among students aged 6–17 years in Suzhou
  12. Investigation of androgen receptor gene CAG repeat length polymorphism in pubertal gynecomastia
  13. A single-centre study of genetic mutations, audiology, echocardiogram and pulmonary function in Saudi children with osteogenesis imperfecta
  14. A 10-year retrospective single-center study of alpha-fetoprotein and beta-human chorionic gonadotropin in Romanian children with (para)gonadal tumors and cysts
  15. Clinical, pathological and molecular spectrum of patients with glycogen storage diseases in Pakistan
  16. Allelic dropout in PAH affecting the results of genetic diagnosis in phenylketonuria
  17. Short Communication
  18. Role of the SARS-CoV-2 virus in the appearance of new onset type 1 diabetes mellitus in children in Gran Canaria, Spain
  19. Case Reports
  20. 3-M syndrome – a primordial short stature disorder with novel CUL7 mutation in two Indian patients
  21. The coincidence of two rare diseases with opposite metabolic phenotype: a child with congenital hyperinsulinism and Bloom syndrome
  22. Growth hormone deficiency in a child with benign hereditary chorea caused by a de novo mutation of the TITF1/NKX2-1 gene
  23. Identification of a novel mutation in the PHKA2 gene in a child with liver cirrhosis
https://doi.org/10.1515/jpem-2021-0519
Keywords for this article
adrenal insufficiency; cortisol; cut-off levels; steroid analysis

Articles in the same Issue

  1. Frontmatter
  2. Review Article
  3. Congenital hyperinsulinism: recent updates on molecular mechanisms, diagnosis and management
  4. Original Articles
  5. Weight changes of children in 1 year during COVID-19 pandemic
  6. Three novel mutations of the BCKDHA, BCKDHB and DBT genes in Chinese children with maple syrup urine disease
  7. Rates of adrenal insufficiency using a monoclonal vs. polyclonal cortisol assay
  8. Hyperinsulinemic hypoglycemia in growth restricted convalescent preterm neonates: clinical characteristics and impediments to early diagnosis
  9. Identification of three novel pathogenic mutations in cystathionine beta-synthase gene of Pakistani intellectually disabled patients
  10. The prevalence of incidental finding of gynecomastia on thoracic computed tomography in the pediatric age group
  11. The prevalence of hypertension and elevated blood pressure and its correlation with overweight/obesity among students aged 6–17 years in Suzhou
  12. Investigation of androgen receptor gene CAG repeat length polymorphism in pubertal gynecomastia
  13. A single-centre study of genetic mutations, audiology, echocardiogram and pulmonary function in Saudi children with osteogenesis imperfecta
  14. A 10-year retrospective single-center study of alpha-fetoprotein and beta-human chorionic gonadotropin in Romanian children with (para)gonadal tumors and cysts
  15. Clinical, pathological and molecular spectrum of patients with glycogen storage diseases in Pakistan
  16. Allelic dropout in PAH affecting the results of genetic diagnosis in phenylketonuria
  17. Short Communication
  18. Role of the SARS-CoV-2 virus in the appearance of new onset type 1 diabetes mellitus in children in Gran Canaria, Spain
  19. Case Reports
  20. 3-M syndrome – a primordial short stature disorder with novel CUL7 mutation in two Indian patients
  21. The coincidence of two rare diseases with opposite metabolic phenotype: a child with congenital hyperinsulinism and Bloom syndrome
  22. Growth hormone deficiency in a child with benign hereditary chorea caused by a de novo mutation of the TITF1/NKX2-1 gene
  23. Identification of a novel mutation in the PHKA2 gene in a child with liver cirrhosis
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