Nearly 7% of the world's population live with a
hemoglobin variant.
Hemoglobins S, C, and E are the most common and significant
hemoglobin variants worldwide.
Sickle cell disease, caused by
hemoglobin S, is highly prevalent in sub-Saharan Africa and in tribal populations of Central India.
Hemoglobin C is common in West Africa, and
hemoglobin E is common in Southeast Asia. Screening for significant
hemoglobin disorders is not currently feasible in many low-income countries with the high disease burden. Lack of early diagnosis leads to preventable high morbidity and mortality in children born with
hemoglobin variants in low-resource settings. Here, we describe HemeChip, the first miniaturized, paper-based, microchip electrophoresis platform for identifying the most common
hemoglobin variants easily and affordably at the point-of-care in low-resource settings. HemeChip test works with a drop of blood. HemeChip system guides the user step-by-step through the test procedure with animated on-screen instructions.
Hemoglobin identification and quantification is automatically performed, and
hemoglobin types and percentages are displayed in an easily understandable, objective way. We show the feasibility and high accuracy of HemeChip via testing 768 subjects by clinical sites in the United States, Central India, sub-Saharan Africa, and Southeast Asia. Validation studies include
hemoglobin E testing in Bangkok, Thailand, and
hemoglobin S testing in Chhattisgarh, India, and in Kano, Nigeria, where the
sickle cell disease burden is the highest in the world. Tests were performed by local users, including healthcare workers and clinical laboratory personnel. Study design, methods, and results are presented according to the Standards for Reporting Diagnostic Accuracy (STARD). HemeChip correctly identified all subjects with
hemoglobin S, C, and E variants with 100% sensitivity, and displayed an overall diagnostic accuracy of 98.4% in comparison to reference standard methods. HemeChip is a versatile, mass-producible microchip electrophoresis platform that addresses a major unmet need of decentralized
hemoglobin analysis in resource-limited settings.