Validation of the Gazelle point-of-care device for hemoglobin variant analysis in a predominantly pediatric population: performance comparison with conventional electrophoresis.

Sickle cell disease (SCD) is a group of genetic hemoglobinopathies that lead to significant morbidity and mortality including vaso-occlusive crises, hemolysis, and progressive organ damage. 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. Results showed variable precision across hemoglobin variants, strong linearity for Hb A (R 2 ≥ 0.95), and high correlation (R 2 > 0.95) for Hb A, F, and S. These findings support the potential use of Gazelle for SCD screening in children, particularly in resource-limited settings.