1. Paper-based microchip electrophoresis for point-of-care hemoglobin testing
- Author
-
Stephen K. Obaro, Melissa S. Creary, Nicholas Kocmich, Aparup Das, Asya Akkus, Julia Z. Xu, Arwa Fraiwan, Vip Viprakasit, Priyaleela Thota, Tolulope Oginni, Takdanai Ngimhung, Jane A. Little, Umut A. Gurkan, Fatimah Hassan-Hanga, Grace Olanipekun, Connie M. Piccone, Yunus Alapan, Praveen K. Bharti, Binta W. Jibir, Ryan Ung, Ran An, Suchada Riolueang, Greg Werner, Rajasubramaniam Shanmugam, Amy J. Rezac, Safiya Gambo, Muhammad Noman Hasan, Thidarat Suksangpleng, and Anil Kumar Verma
- Subjects
Paper ,Pediatrics ,medicine.medical_specialty ,Point-of-Care Systems ,Population ,Hemoglobin, Sickle ,Disease ,Biochemistry ,Article ,Analytical Chemistry ,Electrophoresis, Microchip ,03 medical and health sciences ,Hemoglobins ,User-Computer Interface ,0302 clinical medicine ,Electrochemistry ,Image Processing, Computer-Assisted ,Environmental Chemistry ,Medicine ,Humans ,education ,Spectroscopy ,Disease burden ,030304 developmental biology ,Point of care ,0303 health sciences ,education.field_of_study ,Miniaturization ,business.industry ,Hemoglobin variants ,medicine.disease ,3. Good health ,Hemoglobin C ,030220 oncology & carcinogenesis ,Hemoglobin E ,Hemoglobin ,business - Abstract
Nearly 7% of the world’s population lives 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.
- Published
- 2020