Establishment of the Separate Cutoff Values of 17-alpha-hydroxyprogesterone in Neonatal Screening Program for Congenital Adrenal Hyperplasia according to Birth Weight.
- Author:
Sean Mi SONG
1
;
Hyang Ja LEE
;
Hye Ryung YOON
;
Kyoung Ryul LEE
Author Information
1. Department of Laboratory Medicine, Hanyang General Hospitaa, Namyangju, Korea. drssm@naver.com
- Publication Type:Original Article
- Keywords:
Neonatal screening;
17-alpha-hydroxyprogesterone;
Congenital adrenal hyperplasia;
Low-birth-weight infants
- MeSH:
17-alpha-Hydroxyprogesterone;
Adrenal Hyperplasia, Congenital;
Anxiety;
Birth Weight;
Delivery of Health Care;
Humans;
Infant;
Infant, Low Birth Weight;
Infant, Newborn;
Infant, Premature;
Infant, Very Low Birth Weight;
Korea;
Neonatal Screening;
Parents;
Parturition
- From:Journal of Laboratory Medicine and Quality Assurance
2010;32(2):211-216
- CountryRepublic of Korea
- Language:Korean
-
Abstract:
BACKGROUND: In Korea, 17-alpha-hydroxyprogesterone (17-OHP) neonatal screening for congenital adrenal hyperplasia (CAH) has a high false positive rate. Preterm infants have higher levels of 17-OHP than term infants. We established the separate cutoff values of 17-OHP under the guideline of the Clinical and Laboratory Standard Institute C28-A3 to reduce a false positive rate. METHODS: The 17-OHP enzyme-immunoassay was used in blood spots of 22,601 newborns. To decide whether to partition cutoff values based on sex, sampling date and birth weight was assessed by Z-test and standard deviation (SD) ratio. If the result was significant, we estimated the cutoff value with 90% confidence intervals (CIs) using the nonparametric method. RESULTS: In the subclasses based on sex and sampling date, the results were not significant. However, the birth weight-adjusted subclasses (SD ratio > 1.5) showed that it was necessary to distinguish low-birth-weight infants from the others. We selected the subclass categories to reflect the concept of low- or very-low-birth-weight infant. The maximum percentile to define a 90% CI was chosen in each subclass. After applied the re-estimated cutoff value, the recall rate was decreased from 0.6% to less than 0.2%. CONCLUSIONS: The birth weight-adjusted cutoff value of 17-OHP in neonatal screening for CAH can be reduced the false positive rate of low-birth-weight infants. This approach would decrease unnecessary blood draws, medical evaluation, parental anxiety and burden on health care resources.