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Updated: Mar 7, 2026
A Precision Medicine Tool for Measurement and Monitoring of Hemoglobin S in Sickle Cell Disease Patients Receiving Transfusion Therapy
Impact of prematurity and immigration on neonatal screening for sickle cell disease
Ernesto Cortés-Castell1, Antonio Palazón-Bru2, Carolina Pla3
1Department of Pharmacology, Pediatrics and Organic Chemistry, Miguel Hernández University, San Juan de Alicante, Alicante, Spain.
Insights
Neonatal hemoglobin A levels vary significantly by maternal origin and gestational age. Establishing these normal cut-offs is crucial for accurate screening and identifying potential health issues in newborns.
Area of Science:
- Neonatal screening
- Hematology
- Public health
Background:
- Existing research shows a link between hemoglobin A levels and factors like gestational age, gender, and ethnicity.
- However, specific normal cut-off points considering these variables are lacking.
- This study addresses the need for precise reference ranges for neonatal hemoglobin A levels.
Purpose of the Study:
- To determine the percentiles of normality for neonatal hemoglobin A levels.
- To account for variations based on maternal origin, gender, and gestational age.
- To establish accurate reference ranges for improved neonatal screening.
Main Methods:
- A cross-sectional study of 16,025 neonatal samples was conducted in Alicante, Spain.
- Quantile regression models and bootstrap samples were used to determine 1st and 99th percentiles.
- Hemoglobin A levels were analyzed against secondary variables: gender, gestational age, and maternal origin.
Main Results:
- Hemoglobin A normality levels demonstrated significant variation based on maternal origin and gestational age.
- Analysis revealed a substantial proportion (74%) of potential hemoglobin E carriers had above-normal hemoglobin A levels.
- Established percentiles of normality differed across various maternal origins and gestational ages.
Conclusions:
- The established normality levels can aid in identifying samples with unrecorded blood transfusions.
- The methodology offers a framework for refining screening protocols for other neonatal diseases.
- Accurate reference ranges are vital for effective neonatal health monitoring and early detection.
Background:
Others have described a relationship between hemoglobin A levels and gestational age, gender and ethnicity. However, studies are needed to determine normal cut-off points considering these factors. To address this issue we designed a study to determine the percentiles of normality of neonatal hemoglobin A levels taking these factors into account.
Methods:
This cross-sectional study involved 16,025 samples for sickle cell disease screening in the province of Alicante, Spain, which has a high immigration rate. The primary variable was hemoglobin A, and the secondary variables were gender, gestational age (preterm and full term) and maternal origin (Spain, the rest of Europe, North Africa, Sub-Saharan Africa, Latin America and Asia). Percentiles of normality (1 and 99) were obtained by origin, gender and gestational age using quantile regression models and bootstrap samples. The association between these percentiles of normality and altered levels (≥1%) of hemoglobin E was analyzed. We obtained the percentiles of normality (1 and 99) for each maternal origin, gender and gestational age.
Results:
Of a total of 88 possible E carriers, 65 had above-normal hemoglobin A levels (74%). The levels of normality for hemoglobin A varied greatly according to the maternal origin and gestational age.
Conclusion:
With the levels of normality that we established it is possible to discard samples with unrecorded blood transfusions. Our methodology could be applied to other diseases in the neonatal screening.
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