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Among various Hb disorders, approximately 1.5% of the world population carries \u03b2-thalassemia (\u03b2-Thal), affecting 40,000 newborns every year. Early screening and a timely diagnosis are essential for \u03b2-thalassemia patients for the prevention and management of later clinical complications. However, in Africa, Southern Europe, the Middle East, and Southeast Asia, where \u03b2-thalassemia is most prevalent, the diagnosis and screening for \u03b2-thalassemia are still challenging due to the cost and logistical burden of laboratory diagnostic tests. Here, we present Gazelle, which is a paper-based microchip electrophoresis platform that enables the first point-of-care diagnostic test for \u03b2-thalassemia. We evaluated the accuracy of Gazelle for the \u03b2-Thal screening across 372 subjects in the age range of 4\u201363 years at Apple Diagnostics lab in Mumbai, India. Additionally, 30 blood samples were prepared to mimic \u03b2-Thal intermediate and \u03b2-Thal major samples. Gazelle-detected levels of Hb A, Hb F, and Hb A2 demonstrated high levels of correlation with the results reported through laboratory gold standard high-performance liquid chromatography (HPLC), yielding a Pearson correlation coefficient = 0.99. This ability to obtain rapid and accurate results suggests that Gazelle may be suitable for the large-scale screening and diagnosis of \u03b2-Thal.<\/jats:p>","DOI":"10.3390\/bios14020083","type":"journal-article","created":{"date-parts":[[2024,2,2]],"date-time":"2024-02-02T09:42:32Z","timestamp":1706866952000},"page":"83","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":13,"title":["Point-of-Care Diagnostic Test for Beta-Thalassemia"],"prefix":"10.3390","volume":"14","author":[{"given":"Ran","family":"An","sequence":"first","affiliation":[{"name":"Department of Mechanical and Aerospace Engineering, Case Western Reserve University, Cleveland, OH 44106, USA"},{"name":"Department of Biomedical Engineering, University of Houston, Houston, TX 77004, USA"},{"name":"Department of Biomedical Sciences, University of Houston, Houston, TX 77004, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7145-5921","authenticated-orcid":false,"given":"Alireza","family":"Avanaki","sequence":"additional","affiliation":[{"name":"HemexHealth, Inc., Portland, OR 97239, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Priyaleela","family":"Thota","sequence":"additional","affiliation":[{"name":"HemexHealth, Inc., Portland, OR 97239, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sai","family":"Nemade","sequence":"additional","affiliation":[{"name":"Plasma Lab, Jalgaon 425001, India"},{"name":"Apple Diagnostics Lab, Ghatkopar, Mumbai 400077, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Amrish","family":"Mehta","sequence":"additional","affiliation":[{"name":"Plasma Lab, Jalgaon 425001, India"},{"name":"Apple Diagnostics Lab, Ghatkopar, Mumbai 400077, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0331-9960","authenticated-orcid":false,"given":"Umut A.","family":"Gurkan","sequence":"additional","affiliation":[{"name":"Department of Mechanical and Aerospace Engineering, Case Western Reserve University, Cleveland, OH 44106, USA"},{"name":"Department of Biomedical Engineering, Case Western Reserve University, Cleveland, OH 44106, USA"},{"name":"Case Comprehensive Cancer Center, Case Western Reserve University, Cleveland, OH 44106, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2024,2,2]]},"reference":[{"key":"ref_1","unstructured":"WHO (2022, January 11). Newborn Health in the Western Pacific. Available online: https:\/\/www.who.int\/westernpacific\/health-topics\/newborn-health."},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"727","DOI":"10.1056\/NEJMra2021838","article-title":"\u03b2-Thalassemias","volume":"384","author":"Taher","year":"2021","journal-title":"N. Engl. J. Med."},{"key":"ref_3","doi-asserted-by":"crossref","first-page":"480","DOI":"10.2471\/BLT.06.036673","article-title":"Global epidemiology of haemoglobin disorders and derived service indicators","volume":"86","author":"Modell","year":"2008","journal-title":"Bull. World Health Organ."},{"key":"ref_4","doi-asserted-by":"crossref","first-page":"602","DOI":"10.1177\/014107680109401119","article-title":"Disorders of Hemoglobin: Genetics, Pathophysiology, and Clinical Management","volume":"94","author":"Somervaille","year":"2001","journal-title":"J. R. Soc. Med."},{"key":"ref_5","doi-asserted-by":"crossref","unstructured":"Bender, M.A., Hulihan, M., Dorley, M.C., del Pilar Aguinaga, M., Ojodu, J., and Yusuf, C. (2021). Newborn Screening Practices for Beta-Thalassemia in the United States. Int. J. Neonatal Screen., 7.","DOI":"10.3390\/ijns7040083"},{"key":"ref_6","doi-asserted-by":"crossref","first-page":"105","DOI":"10.1007\/BF03165098","article-title":"Carrier screening and genetic counselling in beta-thalassemia","volume":"76","author":"Cao","year":"2002","journal-title":"Int. J. Hematol."},{"key":"ref_7","first-page":"1528","article-title":"Need for a universal thalassemia screening programme in India?","volume":"8","author":"Bhattacharya","year":"2019","journal-title":"A public health perspective. J. Fam. Med. Prim. Care"},{"key":"ref_8","doi-asserted-by":"crossref","first-page":"897","DOI":"10.1080\/17474086.2021.1977116","article-title":"Improving outcomes and quality of life for patients with transfusion-dependent \u03b2-thalassemia: Recommendations for best clinical practice and the use of novel treatment strategies","volume":"14","author":"Taher","year":"2021","journal-title":"Expert Rev. Hematol."},{"key":"ref_9","first-page":"621","article-title":"Awareness among parents of children with thalassemia major","volume":"58","author":"Arif","year":"2008","journal-title":"J. Pak. Med. Assoc."},{"key":"ref_10","doi-asserted-by":"crossref","first-page":"692","DOI":"10.1111\/ejh.13512","article-title":"Changing patterns in the epidemiology of \u03b2-thalassemia","volume":"105","author":"Kattamis","year":"2020","journal-title":"Eur. J. Haematol."},{"key":"ref_11","doi-asserted-by":"crossref","first-page":"1573","DOI":"10.3324\/haematol.2011.055962","article-title":"Beta-thalassemia: From genotype to phenotype","volume":"96","author":"Danjou","year":"2011","journal-title":"Haematologica"},{"key":"ref_12","unstructured":"Origa, R. (1993). Beta-Thalassemia, University of Washington."},{"key":"ref_13","doi-asserted-by":"crossref","first-page":"609","DOI":"10.1038\/gim.2016.173","article-title":"\u03b2-Thalassemia","volume":"19","author":"Origa","year":"2017","journal-title":"Genet. Med."},{"key":"ref_14","doi-asserted-by":"crossref","first-page":"1135","DOI":"10.1056\/NEJMra050436","article-title":"Beta-thalassemia","volume":"353","author":"Rund","year":"2005","journal-title":"N. Engl. J. Med."},{"key":"ref_15","first-page":"CD014584","article-title":"Point-of-care diagnostic tests for sickle cell disease","volume":"2022","author":"Kawooya","year":"2022","journal-title":"Cochrane Database Syst. Rev."},{"key":"ref_16","doi-asserted-by":"crossref","unstructured":"Clemente, F., Antonacci, A., Giardi, M.T., Frisulli, V., Tambaro, F.P., and Scognamiglio, V. (2023). Last Trends in Point-of-Care (POC) Diagnostics for the Management of Hematological Indices in Home Care Patients. Biosensors, 13.","DOI":"10.3390\/bios13030345"},{"key":"ref_17","doi-asserted-by":"crossref","unstructured":"Bond, M., Hunt, B., Flynn, B., Huhtinen, P., Ware, R., and Richards-Kortum, R. (2017). Towards a point-of-care strip test to diagnose sickle cell anemia. PLoS ONE, 12.","DOI":"10.1371\/journal.pone.0177732"},{"key":"ref_18","doi-asserted-by":"crossref","first-page":"104","DOI":"10.1016\/j.bcmd.2017.08.010","article-title":"The pressing need for point-of-care diagnostics for sickle cell disease: A review of current and future technologies","volume":"67","author":"McGann","year":"2017","journal-title":"Blood Cells Mol. Dis."},{"key":"ref_19","doi-asserted-by":"crossref","unstructured":"Arishi, W.A., Alhadrami, H.A., and Zourob, M. (2021). Techniques for the Detection of Sickle Cell Disease: A Review. Micromachines, 12.","DOI":"10.3390\/mi12050519"},{"key":"ref_20","doi-asserted-by":"crossref","first-page":"85","DOI":"10.1016\/j.cca.2019.10.025","article-title":"Emerging point-of-care technologies for sickle cell disease diagnostics","volume":"501","author":"Ilyas","year":"2020","journal-title":"Clin. Chim. Acta"},{"key":"ref_21","doi-asserted-by":"crossref","first-page":"84","DOI":"10.1097\/POC.0000000000000210","article-title":"Analytic Characteristics and Performance of Novel Immunoassay Point-of-Care Tests for Early Diagnosis of Sickle Cell Disease a Systematic Review","volume":"19","author":"Jaja","year":"2020","journal-title":"Point Care"},{"key":"ref_22","doi-asserted-by":"crossref","first-page":"736","DOI":"10.1136\/jcp.23.8.736","article-title":"An assessment of Sickledex as an alternative to the sickling test","volume":"23","author":"Canning","year":"1970","journal-title":"J. Clin. Pathol."},{"key":"ref_23","doi-asserted-by":"crossref","first-page":"39","DOI":"10.1002\/ajh.25305","article-title":"Point-of-care screening for sickle cell disease in low-resource settings: A multi-center evaluation of HemoTypeSC, a novel rapid test","volume":"94","author":"Steele","year":"2019","journal-title":"Am. J. Hematol."},{"key":"ref_24","doi-asserted-by":"crossref","unstructured":"Kanter, J., Telen, M.J., Hoppe, C., Roberts, C.L., Kim, J.S., and Yang, X. (2015). Validation of a novel point of care testing device for sickle cell disease. BMC Med., 13.","DOI":"10.1186\/s12916-015-0473-6"},{"key":"ref_25","unstructured":"WHO World Health Organization (2019). First WHO Model List of Essential In Vitro Diagnostics, WHO."},{"key":"ref_26","doi-asserted-by":"crossref","first-page":"1843","DOI":"10.1039\/D0LC01235A","article-title":"Emerging point-of-care technologies for anemia detection","volume":"21","author":"An","year":"2021","journal-title":"Lab A Chip"},{"key":"ref_27","unstructured":"WHO (2019). Second WHO Model List of Essential In Vitro Diagnostics, WHO. WHO\/MVP\/EMP\/2019.05."},{"key":"ref_28","doi-asserted-by":"crossref","first-page":"e207","DOI":"10.1017\/cts.2021.871","article-title":"A retrospective case study of successful translational research: Gazelle Hb variant point-of-care diagnostic device for sickle cell disease","volume":"5","author":"Qua","year":"2021","journal-title":"J. Clin. Transl. Sci."},{"key":"ref_29","doi-asserted-by":"crossref","unstructured":"An, R., Hasan, M.N., Man, Y., and Gurkan, U.A. (2019, January 20\u201322). Integrated Point-of-Care Device for Anemia Detection and Hemoglobin Variant Identification. Proceedings of the 2019 IEEE Healthcare Innovations and Point of Care Technologies, (HI-POCT), Bethesda, ML, USA.","DOI":"10.1109\/HI-POCT45284.2019.8962876"},{"key":"ref_30","doi-asserted-by":"crossref","first-page":"2525","DOI":"10.1039\/C9AN02250C","article-title":"Paper-based microchip electrophoresis for point-of-care hemoglobin testing","volume":"145","author":"Hasan","year":"2020","journal-title":"Analyst"},{"key":"ref_31","doi-asserted-by":"crossref","unstructured":"Hasan, M.N., An, R., Akkus, A., Akkaynak, D., Minerick, A.R., Kharangate, C.R., and Gurkan, U.A. (2021). Dynamic pH and Thermal Analysis of Paper-Based Microchip Electrophoresis. Micromachines, 12.","DOI":"10.3390\/mi12111433"},{"key":"ref_32","doi-asserted-by":"crossref","first-page":"e11778","DOI":"10.1016\/j.heliyon.2022.e11778","article-title":"Multispectral imaging for MicroChip electrophoresis enables point-of-care newborn hemoglobin variant screening","volume":"8","author":"An","year":"2022","journal-title":"Heliyon"},{"key":"ref_33","unstructured":"Centers for Disease Control and Prevention (2015). Hemoglobinopathies: Current Practices for Screening, Confirmation and Follow-Up."},{"key":"ref_34","doi-asserted-by":"crossref","first-page":"3863","DOI":"10.1039\/D1LC00371B","article-title":"Point-of-care microchip electrophoresis for integrated anemia and hemoglobin variant testing","volume":"21","author":"An","year":"2021","journal-title":"Lab A Chip"},{"key":"ref_35","doi-asserted-by":"crossref","first-page":"f2778","DOI":"10.1136\/bmj.f2778","article-title":"Diagnostic accuracy studies: How to report and analyse inconclusive test results","volume":"346","author":"Shinkins","year":"2013","journal-title":"BMJ Br. Med. J."},{"key":"ref_36","doi-asserted-by":"crossref","first-page":"1446","DOI":"10.1373\/clinchem.2015.246280","article-title":"STARD 2015: An Updated List of Essential Items for Reporting Diagnostic Accuracy Studies","volume":"61","author":"Bossuyt","year":"2015","journal-title":"Clin. Chem."},{"key":"ref_37","doi-asserted-by":"crossref","first-page":"35","DOI":"10.1111\/j.1365-2141.2009.08054.x","article-title":"Significant haemoglobinopathies: Guidelines for screening and diagnosis","volume":"149","author":"Ryan","year":"2010","journal-title":"Br. J. Haematol."}],"container-title":["Biosensors"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/2079-6374\/14\/2\/83\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,10]],"date-time":"2025-10-10T13:54:04Z","timestamp":1760104444000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/2079-6374\/14\/2\/83"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,2,2]]},"references-count":37,"journal-issue":{"issue":"2","published-online":{"date-parts":[[2024,2]]}},"alternative-id":["bios14020083"],"URL":"https:\/\/doi.org\/10.3390\/bios14020083","relation":{},"ISSN":["2079-6374"],"issn-type":[{"value":"2079-6374","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,2,2]]}}}