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Title: Paper-based microchip electrophoresis for point-of-care hemoglobin testing
Authors: Muhammad Noman Hasan
Arwa Fraiwan
Ran An
Yunus Alapan
Ryan Ung
Asya Akkus
Julia Z. Xu
Amy J. Rezac
Nicholas J. Kocmich
Melissa S. Creary
Tolulope Oginni
Grace Mfon Olanipekun
Fatimah Hassan-Hanga
Binta W. Jibir
Safiya Gambo
Anil K. Verma
Praveen K. Bharti
Suchada Riolueang
Takdanai Ngimhung
Thidarat Suksangpleng
Priyaleela Thota
Greg Werner
Rajasubramaniam Shanmugam
Aparup Das
Vip Viprakasit
Connie M. Piccone
Jane A. Little
Stephen K. Obaro
Umut A. Gurkan
Duke University Medical Center
University Hospitals Rainbow Babies & Children's Hospital
Max Planck Institute for Intelligent Systems
Indian Council of Medical Research
University Hospitals Case Medical Center
UNC School of Medicine
University of Michigan School of Public Health
University of Nebraska Medical Center
Faculty of Medicine, Siriraj Hospital, Mahidol University
Bayero University
Case Western Reserve University
Thogus Products
Hasiya Bayero Pediatric Hospital
International Foundation Against Infectious Diseases in Nigeria
eHealth Africa
Murtala Muhammad Specialist Hospital
Keywords: Biochemistry, Genetics and Molecular Biology;Chemistry;Environmental Science
Issue Date: 7-Apr-2020
Citation: Analyst. Vol.145, No.7 (2020), 2525-2542
Abstract: © 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.
ISSN: 13645528
Appears in Collections:Scopus 2020

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