SickleInAfrica Consortium: A Seven-Country Study Evaluating the Performance of Dried Blood Spot Point-of-Care Testing in Newborn Screening for Sickle Cell Disease.

Sickle cell disease (SCD) remains a major public health concern in sub-Saharan Africa (SSA), where approximately 200,000 newborns are affected annually. Without early diagnosis and access to care, up to 50% of these children may die before the age of five. Although newborn screening (NBS) programs have proven effective in improving survival, their implementation across Africa is constrained by logistical barriers associated with standard diagnostic methods such as isoelectric focusing (IEF), high-performance liquid chromatography (HPLC), and cellulose acetate electrophoresis. Dried blood spot point-of-care testing (DBS-POCT) offers a potentially scalable alternative due to its stability, simplicity, and suitability for centralized analysis. We evaluated the diagnostic accuracy of DBS-POCT using the HemoTypeSC test compared to both standard POCT and reference laboratory testing across 705 newborns (0-3 months old) in seven countries within the SickleInAfrica Consortium. DBS-POCT demonstrated high sensitivity and specificity for detecting HbAA and HbAS, moderate sensitivity for HbSS, and lower sensitivity for HbAC, with some variability across countries. In several countries, DBS-POCT outperformed standard POCT, particularly in detecting SCD subtypes. Our findings support the utility of DBS-POCT for expanding newborn screening programs in resource-limited settings.