Muhammad Noman HasanArwa FraiwanRan AnYunus AlapanRyan UngAsya AkkusJulia Z. XuAmy J. RezacNicholas J. KocmichMelissa S. CrearyTolulope OginniGrace Mfon OlanipekunFatimah Hassan-HangaBinta W. JibirSafiya GamboAnil K. VermaPraveen K. BhartiSuchada RiolueangTakdanai NgimhungThidarat SuksangplengPriyaleela ThotaGreg WernerRajasubramaniam ShanmugamAparup DasVip ViprakasitConnie M. PicconeJane A. LittleStephen K. ObaroUmut A. GurkanDuke University Medical CenterUniversity Hospitals Rainbow Babies & Children's HospitalMax Planck Institute for Intelligent SystemsIndian Council of Medical ResearchUniversity Hospitals Case Medical CenterUNC School of MedicineUniversity of Michigan School of Public HealthUniversity of Nebraska Medical CenterFaculty of Medicine, Siriraj Hospital, Mahidol UniversityBayero UniversityCase Western Reserve UniversityThogus ProductsHEMEX HEALTH, INC.Hasiya Bayero Pediatric HospitalInternational Foundation Against Infectious Diseases in NigeriaeHealth AfricaMurtala Muhammad Specialist Hospital2020-05-052020-05-052020-04-07Analyst. Vol.145, No.7 (2020), 2525-254213645528000326542-s2.0-85082769702https://repository.li.mahidol.ac.th/handle/20.500.14594/54462© The Royal Society of Chemistry 2020. 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.Mahidol UniversityBiochemistry, Genetics and Molecular BiologyChemistryEnvironmental ScienceArticleSCOPUS10.1039/c9an02250c