Clinica chimica acta; international journal of clinical chemistry · 2026
Impact of temperature on hemoglobin stability in dried blood spots for newborn screening for sickle cell disease.
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Rolla R, Vidali M, Giacomini L, Sacchetti S, Dianzani U, Ammirabile M, Paleari R
Аннотация
BACKGROUND: Sickle cell disease (SCD) is a major genetic disorder with a growing global burden, particularly in sub-Saharan Africa. Newborn screening based on dried blood spot (DBS) samples is an effective strategy for early diagnosis; however, prolonged transport times and exposure to high temperatures may compromise analytical reliability in resource-limited settings.
METHODS: We evaluated the stability of hemoglobin fractions (HbF, HbA0, HbS, HbFast, and acetylated HbF) in DBS samples stored at +4 °C, +37 °C, and + 42 °C for up to 30 days. Native cord blood samples and samples spiked with HbS (~5% or ~ 15%) were analysed by cation-exchange high-performance liquid chromatography (CX-HPLC; VARIANT® NBS system). Stability was assessed using a regression-based approach in accordance with European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) recommendations, estimating time-dependent trends, daily rates of change, and stability limits.
RESULTS: Storage temperature was the main determinant of hemoglobin stability. At +4 °C, most hemoglobin fractions showed no significant time-dependent trends over 30 days. At +37 °C and + 42 °C, several fractions exhibited statistically significant changes, with increasing daily variation rates and markedly reduced stability limits. HbFast showed the shortest stability limits at elevated temperatures, while HbA0 and HbF displayed intermediate stability profiles. HbS showed reduced stability at higher temperatures, with borderline or unstable classifications and short stability limits, particularly in samples with lower HbS levels. Overall, stability classifications and estimated stability limits consistently worsened with increasing temperature.
CONCLUSIONS: Hemoglobin stability in DBS samples is strongly temperature-dependent and follows analyte-specific degradation patterns. The application of a regression-based EFLM framework enables a quantitative and reproducible assessment of stability and supports the definition of operational storage limits. These findings provide evidence-based guidance for optimizing DBS storage and transport conditions and support the implementation of scalable SCD screening programs in resource-limited settings.
METHODS: We evaluated the stability of hemoglobin fractions (HbF, HbA0, HbS, HbFast, and acetylated HbF) in DBS samples stored at +4 °C, +37 °C, and + 42 °C for up to 30 days. Native cord blood samples and samples spiked with HbS (~5% or ~ 15%) were analysed by cation-exchange high-performance liquid chromatography (CX-HPLC; VARIANT® NBS system). Stability was assessed using a regression-based approach in accordance with European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) recommendations, estimating time-dependent trends, daily rates of change, and stability limits.
RESULTS: Storage temperature was the main determinant of hemoglobin stability. At +4 °C, most hemoglobin fractions showed no significant time-dependent trends over 30 days. At +37 °C and + 42 °C, several fractions exhibited statistically significant changes, with increasing daily variation rates and markedly reduced stability limits. HbFast showed the shortest stability limits at elevated temperatures, while HbA0 and HbF displayed intermediate stability profiles. HbS showed reduced stability at higher temperatures, with borderline or unstable classifications and short stability limits, particularly in samples with lower HbS levels. Overall, stability classifications and estimated stability limits consistently worsened with increasing temperature.
CONCLUSIONS: Hemoglobin stability in DBS samples is strongly temperature-dependent and follows analyte-specific degradation patterns. The application of a regression-based EFLM framework enables a quantitative and reproducible assessment of stability and supports the definition of operational storage limits. These findings provide evidence-based guidance for optimizing DBS storage and transport conditions and support the implementation of scalable SCD screening programs in resource-limited settings.