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Establishing 17-Hydroxyprogesterone Cutoff Values for Congenital Adrenal Hyperplasia in Preterm, Low Birth Weight,
Young Ahn Yoon1, Suhyeon Woo1, Min-Sun Kim1
1Department of Laboratory Medicine, Soonchunhyang University Cheonan Hospital, Soonchunhyang University College of Medicine, Cheonan, Korea.
Insights
Newborn screening for congenital adrenal hyperplasia (CAH) can be improved by adjusting 17-hydroxyprogesterone (17-OHP) cutoff values based on birth weight and gestational age. This reduces false positives and unnecessary follow-up tests for newborns.
Area of Science:
- Biochemistry
- Neonatal Medicine
- Genetics
Background:
- Newborn screening for congenital adrenal hyperplasia (CAH) is widely adopted but suffers from high false positive rates.
- These false positives cause family stress, economic burdens, and unnecessary hospital visits for newborns.
- Accurate 17-hydroxyprogesterone (17-OHP) levels are crucial for reliable CAH screening.
Purpose of the Study:
- To investigate the influence of birth weight (BW), gestational age (GA), and sampling time on 17-OHP concentrations in newborns.
- To establish new 17-OHP cutoff values for preterm, low birth weight (LBW), and sick newborns to improve screening accuracy.
Main Methods:
- Screened 1,071 newborns for CAH between October 2020 and January 2022.
- Collected neonatal blood samples via heel prick on filter paper.
- Measured 17-OHP concentration using time-resolved immunofluorescence and analyzed data in relation to BW, GA, and sampling time.
Main Results:
- 17-OHP concentration showed a significant negative correlation with BW (r=-0.488) and GA (r=-0.560).
- 17-OHP levels decreased with increasing sampling time in both term and preterm infants.
- New cutoff criteria reduced recall rates to 1.16% (BW), 0.9% (GA), and 1.75% (GA with sampling time).
Conclusions:
- New 17-OHP cutoff values were established for preterm, LBW, and sick newborns.
- These reference data can aid other laboratories in developing improved screening criteria.
- Implementing these new cutoffs can significantly lower recall rates and reduce unnecessary follow-up testing.
Background:
Newborn screening for congenital adrenal hyperplasia (CAH) has benefits with a high adoption rate worldwide. It also has problems of high false positives, which can cause stress to the patient's family with economic losses and unnecessary visits of newborns to hospitals. Therefore, we investigated the influence of birth weight (BW), gestational age (GA), and GA with sampling time on 17-hydroxyprogesterone (17-OHP) concentration and attempted to establish the 17-OHP cutoff values in preterm, low birth weight (LBW), and sick newborns.
Methods:
Newborns (n=1,071) born between October 2020 and January 2022 were screened for CAH. Samples from neonates were collected on filter paper with the heel prick method. 17-OHP concentration was measured by time-resolved immunofluorescence with an AutoDELFIA Neonatal 17-hydroxyprogesteron kit and grouped in relation to BW, GA, and GA with sampling time.
Results:
The median age of newborns at neonatal sample collection was 6 days. 17-OHP concentration showed a statistically significant negative correlation with BW (r=-0.488, p<0.001) and GA (r=-0.560, p<0.001). Full-term and preterm subgroups had a similar decreasing tendency of 17-OHP concentration with increasing sampling time. Application of newly establishing cutoff criteria significantly reduced recall rates to 1.16%, 0.9%, and 1.75% according to each criterion of BW, GA, and GA with sampling time, respectively.
Conclusions:
This study presents new 17-OHP cutoff values for preterm, LBW, and sick newborns. These data in our laboratory can be used as a reference by other laboratories for establishing new cutoff criteria to help lower the high recall rate and reduce unnecessary follow-up tests.
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