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Cited by 114Sexual Differentiation and DisordersAdrenal Hormones and DisordersMetabolism and Genetic Disorders

Cutoff Levels of 17-α-Hydroxyprogesterone in Neonatal Screening for Congenital Adrenal Hyperplasia Should Be Based on Gestational Age Rather Than on Birth Weight

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van der Kamp, Hetty J., Oudshoorn, Caren G. M., Elvers, Bert H., van Baarle, Maja, Otten, Barto J., Wit, Jan M., Verkerk, Paul H.·2005·The Journal of Clinical Endocrinology & Metabolism
DOI 10.1210/jc.2004-2136
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Abstract

Objective: In newborn screening programs for congenital adrenal hyperplasia, 17-α-hydroxyprogesterone (17OHP) cutoff levels are based on birth weight (BW) or on gestational age (GA). We investigated which approach would result in the greatest specificity and sensitivity. Study design: For the determination of 17OHP, a neonatal 17OHP assay was used in filter paper blood of 9492 newborns. The relationships between 17OHP and BW and between 17OHP and GA were studied by regression analysis. Reference curves with a specificity of 99.95% were constructed with the method that summarizes the distribution by three smoothed curves representing the skewness (L curve), the median (M curve), and the coefficient of variation (S curve). Median cutoff levels for BW and for GA according to the 99.95% reference curves were calculated. Results: Regression analysis showed that GA is a better predictor of 17OHP than BW (R2 was 50.6 vs. 35.8%, respectively). At a specificity of 99.95%, the calculated median 17OHP cutoff level was lower for GA [12.6 μg/liter (38 nmol/liter)] than for BW [17.6 μg/liter (54 nmol/liter)], thus leading to a greater sensitivity. Conclusion: This study demonstrates that GA is a better predictor of 17OHP in newborns and will result in greater specificity than BW despite the fact that the determination of GA might be less reliable than BW.

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  • Most laboratories use a series of birth weight-adjusted cut-offs, but actual gestational age, or both, might be preferable, because gestational age correlates much better with 17OHP levels.

    “Most laboratories use a series of birth weight-adjusted cut-offs (253,254) but actual gestational age, or both, might be preferable, because gestational age correlates much better with 17OHP levels (27,255).”

    From Congenital Adrenal Hyperplasia—Current Insights in Pathophysiology, Diagnostics, and Management (2022) · cites this paper as [27]

  • The backdoor pathway has been implicated in the normal development of male genitalia.

    “This pathway has been implicated in the normal development of male genitalia 54”

    From Congenital adrenal hyperplasia (2017) · cites this paper as [54]

  • Stratifying by actual gestational age rather than birth weight might improve newborn screening specificity, because 17-hydroxyprogesterone levels correlate better with gestational age.

    “Stratifying subjects by actual gestational age rather than birth weight might also improve the specificity of newborn screening, as 17OHP levels are much better correlated with the former variable than with the latter (71).”

    From Congenital Adrenal Hyperplasia Due to Steroid 21-Hydroxylase Deficiency: An Endocrine Society* Clinical Practice Guideline (2018) · cites this paper as [71]

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Authors
van der Kamp, H. J., Oudshoorn, C. G. M., Elvers, B. H., van Baarle, M., Otten, B. J., Wit, J. M., & Verkerk, P. H.
Affiliations
  • Department of Pediatrics (H.J.v.d.K., J.M.W.), Leiden University Medical Center, 2300 RC Leiden, The Netherlands;
  • Netherlands Organisation for Applied Scientific Research (NL)
  • National Institute for Public Health and the Environment (NL)
  • General Clinical Laboratory (M.v.B.), IJsselland Hospital, 2900 AR Capelle a/d IJssel, The Netherlands;
  • Radboud University Medical Center (NL)
  • Leiden University Medical Center (NL)
ORCID
Venue
The Journal of Clinical Endocrinology & Metabolism
Publisher
The Endocrine Society
Published
2005-07-01
Volume
90
Issue
7
Pages
3904-3907
ISSN
  • 0021-972X (ISSN-L)
  • 1945-7197
DOI
10.1210/jc.2004-2136
OpenAlex
W2142312973
Cited by
114
References
23
Citations by year
2026: 2 · 2025: 4 · 2024: 3 · 2023: 7 · 2022: 5 · 2021: 15 · 2020: 7 · 2019: 8 · 2018: 4 · 2017: 5 · 2016: 9 · 2015: 6 · 2014: 4 · 2013: 5 · 2012: 5
FWCI
1.13
Type
journal article
Language
en
Open access
Locations
  • The Journal of Clinical Endocrinology & Metabolism (publishedVersion)
  • PubMed (publishedVersion)
  • TNO Repository (submittedVersion)
  • Repository hosted by TU Delft Library (TU Delft) (submittedVersion)
  • Radboud Repository (Radboud University) (submittedVersion)
  • Rivm (National Institute for Public Health and the Environment) (submittedVersion)
  • Data Archiving and Networked Services (DANS) (submittedVersion)
Funders
Leids Universitair Medisch Centrum
Topics
  • Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Sexual Differentiation and Disorders
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Adrenal Hormones and Disorders
  • Life Sciences › Biochemistry, Genetics and Molecular Biology › Clinical Biochemistry › Metabolism and Genetic Disorders
Keywords
congenital adrenal hyperplasia, 17-hydroxyprogesterone, newborn screening, cut-off values, gestational age, birth weight, reference curves
MeSH terms
Adrenal Hyperplasia, Congenital, Birth Weight, Gestational Age, Humans, Infant, Newborn, Regression Analysis, Sensitivity and Specificity, Neonatal Screening, 17-alpha-Hydroxyprogesterone

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