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This version published online on March 29, 2005
Journal of Clinical Endocrinology & Metabolism, doi:10.1210/jc.2004-2136
A more recent version of this article appeared on July 1, 2005
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*OMIM
*Compound via MeSH
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Hazardous Substances DB
*17ALPHA-HYDROXYPROGESTERONE
Medline Plus Health Information
*Newborn Screening

Submitted on November 5, 2004
Accepted on March 18, 2005

Cut-off levels of 17-alpha-hydroxyprogesterone in neonatal screening for congenital adrenal hyperplasia should be based on gestational age rather than on birth weight

Hetty J. van der Kamp*, Caren G.M. Oudshoorn, Bert H. Elvers, Maja van Baarle, Barto J. Otten, Jan M. Wit, and Paul H. Verkerk

Department of Pediatrics, Leiden University Medical Center, P.O.Box 9600, 2300 RC Leiden; TNO Prevention and Health, P.O.Box 2215, 2301 CE Leiden; Diagnostic Laboratory for Infectious Diseases and Perinatal Screening, RIVM, P.O.Box 1, 3720 BA Bilthoven; General Clinical Laboratory, IJsselland Hospital, P.O.Box 690, 2900 AR Capelle a/d Ijssel; Department of Pediatric Endocrinology, University Medical Center St.Radboud, P.O.Box 9101, 6500 HB Nijmegen, The Netherlands

* To whom correspondence should be addressed. E-mail: H.J.van_der_Kamp{at}LUMC.nl.

Objective

In newborn screening programs for CAH, 17-{alpha}-hydroxyprogesterone (17OHP) cut-off levels are based on birth weight or on gestational age. We investigated which approach would result in the greatest specificity and sensitivity.

Study design

For the determination of 17OHP, the AutoDELFIA Neonatal 17OHP assay was used in filter paper blood of 9,492 newborns. The relationships between 17OHP and birth weight and between 17OHP and gestational age were studied by regression analysis. Reference curves with a specificity of 99.95% were constructed with the LMS method. Median cut-off levels for birth weight and for gestational age according to the 99.95% reference curves were calculated

Results

Regression analysis showed that gestational age is a better predictor of 17OHP than birth weight (R2 was 50.6% vs. 35.8%, respectively). At a specificity of 99.95%, the calculated median 17OHP cut-off level was lower for gestational age (12.6 µg/L (38 nmol/L)) than for birth weight (17.6 µg/L (54 nmol/L)) thus leading to a greater sensitivity.

Conclusion

This study demonstrates that gestational age is a better predictor of 17OHP in newborns and will result in greater specificity than birth weight despite the fact that the determination of gestational age might be less reliable than birth weight.
Key words: 21-hydroxylase deficiency • bloodspot • filter paper • specificity • sensitivity






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