Supplementary file 1_Validation of the Gazelle point-of-care device for hemoglobin variant analysis in a predominantly pediatric population: performance comparison with conventional electrophoresis.docx

Early detection is critical to initiate disease-modifying therapy and prevent complications; however, conventional hemoglobin electrophoresis is often unavailable in low-resource settings where SCD is most prevalent. Point-of-care (POC) devices offer a potential solution by enabling rapid, low-cost screening.

The Gazelle POC instrument, which separates hemoglobin variants (A, F, S, and A2/CE) on a cellulose acetate membrane, has been evaluated in limited populations, but its performance relative to conventional electrophoresis methods in pediatric samples remains underexplored. This study validated the analytical and clinical performance of Gazelle using predominantly pediatric whole blood. Precision, linearity, and method comparison studies were conducted with quality control materials and 46 clinical samples analyzed on both Gazelle and the Sebia Capillarys system.