Physische Intelligenz Article 2020

Paper-based microchip electrophoresis for point-of-care hemoglobin testing

C9an02250c f1 hi res

We present a versatile, mass-producible, paper-based microchip electrophoresis platform that enables rapid, affordable, decentralized hemoglobin testing at the point-of-care. , 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.

Author(s): Hasan, Muhammad Noman and Fraiwan, Arwa and An, Ran and Alapan, Yunus and Ung, Ryan and Akkus, Asya and Xu, Julia Z. and Rezac, Amy J. and Kocmich, Nicholas J. and Creary, Melissa S. and Oginni, Tolulope and Olanipekun, Grace Mfon and Hassan-Hanga, Fatimah and Jibir, Binta W. and Gambo, Safiya and Verma, Anil K. and Bharti, Praveen K. and Riolueang, Suchada and Ngimhung, Takdanai and Suksangpleng, Thidarat and Thota, Priyaleela and Werner, Greg and Shanmugam, Rajasubramaniam and Das, Aparup and Viprakasit, Vip and Piccone, Connie M. and Little, Jane A. and Obaro, Stephen K. and Gurkan, Umut A.
Journal: The Analyst
Volume: 145
Number (issue): 7
Pages: 2525--2542
Year: 2020
Bibtex Type: Article (article)
DOI: 10.1039/C9AN02250C
URL: http://xlink.rsc.org/?DOI=C9AN02250C
Electronic Archiving: grant_archive
Language: en

BibTex

@article{hasan_paper-based_2020,
  title = {Paper-based microchip electrophoresis for point-of-care hemoglobin testing},
  journal = {The Analyst},
  abstract = {We present a versatile, mass-producible, paper-based microchip electrophoresis platform that enables rapid, affordable, decentralized hemoglobin testing at the point-of-care.
   , 
   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.},
  volume = {145},
  number = {7},
  pages = {2525--2542},
  year = {2020},
  slug = {hasan_paper-based_2020},
  author = {Hasan, Muhammad Noman and Fraiwan, Arwa and An, Ran and Alapan, Yunus and Ung, Ryan and Akkus, Asya and Xu, Julia Z. and Rezac, Amy J. and Kocmich, Nicholas J. and Creary, Melissa S. and Oginni, Tolulope and Olanipekun, Grace Mfon and Hassan-Hanga, Fatimah and Jibir, Binta W. and Gambo, Safiya and Verma, Anil K. and Bharti, Praveen K. and Riolueang, Suchada and Ngimhung, Takdanai and Suksangpleng, Thidarat and Thota, Priyaleela and Werner, Greg and Shanmugam, Rajasubramaniam and Das, Aparup and Viprakasit, Vip and Piccone, Connie M. and Little, Jane A. and Obaro, Stephen K. and Gurkan, Umut A.},
  url = {http://xlink.rsc.org/?DOI=C9AN02250C}
}