{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,22]],"date-time":"2026-09-22T05:04:15Z","timestamp":1790053455844,"version":"4.0.1"},"reference-count":17,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2026,9,22]],"date-time":"2026-09-22T00:00:00Z","timestamp":1790035200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Med."],"abstract":"<jats:p>\n                    Sickle cell disease (SCD) is a group of genetic hemoglobinopathies that lead to significant morbidity and mortality including vaso-occlusive crises, hemolysis, and progressive organ damage. Early detection is critical to initiate disease-modifying therapy and prevent complications; however, conventional hemoglobin electrophoresis is often unavailable in low-resource settings where SCD is most prevalent. Point-of-care (POC) devices offer a potential solution by enabling rapid, low-cost screening. The Gazelle POC instrument, which separates hemoglobin variants (A, F, S, and A2\/CE) on a cellulose acetate membrane, has been evaluated in limited populations, but its performance relative to conventional electrophoresis methods in pediatric samples remains underexplored. This study validated the analytical and clinical performance of Gazelle using predominantly pediatric whole blood. Precision, linearity, and method comparison studies were conducted with quality control materials and 46 clinical samples analyzed on both Gazelle and the Sebia Capillarys system. Results showed variable precision across hemoglobin variants, strong linearity for Hb A (\n                    <jats:italic>R<\/jats:italic>\n                    <jats:sup>2<\/jats:sup>\n                    \u202f\u2265\u202f0.95), and high correlation (\n                    <jats:italic>R<\/jats:italic>\n                    <jats:sup>2<\/jats:sup>\n                    \u202f&amp;gt;\u202f0.95) for Hb A, F, and S. These findings support the potential use of Gazelle for SCD screening in children, particularly in resource-limited settings.\n                  <\/jats:p>","DOI":"10.3389\/fmed.2026.1903717","type":"journal-article","created":{"date-parts":[[2026,9,22]],"date-time":"2026-09-22T04:26:51Z","timestamp":1790051211000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":0,"title":["Validation of the Gazelle point-of-care device for hemoglobin variant analysis in a predominantly pediatric population: performance comparison with conventional electrophoresis"],"prefix":"10.3389","volume":"13","author":[{"given":"Rebecca J.","family":"Wilson","sequence":"first","affiliation":[{"name":"Department of Pathology and Laboratory Medicine, Cincinnati Children\u2019s Hospital","place":["Cincinnati, OH, United States"]},{"name":"Department of Pathology and Laboratory Medicine, University of Cincinnati College of Medicine","place":["Cincinnati, OH, United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kristina","family":"Prus","sequence":"additional","affiliation":[{"name":"Department of Pathology and Laboratory Medicine, Cincinnati Children\u2019s Hospital","place":["Cincinnati, OH, United States"]},{"name":"Department of Pathology and Laboratory Medicine, University of Cincinnati College of Medicine","place":["Cincinnati, OH, United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fatou","family":"Ka","sequence":"additional","affiliation":[{"name":"Department of Pathology and Laboratory Medicine, University of Cincinnati College of Medicine","place":["Cincinnati, OH, United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joel E.","family":"Mortensen","sequence":"additional","affiliation":[{"name":"Department of Pathology and Laboratory Medicine, Cincinnati Children\u2019s Hospital","place":["Cincinnati, OH, United States"]},{"name":"Department of Pathology and Laboratory Medicine, University of Cincinnati College of Medicine","place":["Cincinnati, OH, United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1965","published-online":{"date-parts":[[2026,9,22]]},"reference":[{"key":"ref1","doi-asserted-by":"publisher","first-page":"2018","DOI":"10.1016\/S0140-6736(10)61029-X","article-title":"Sickle-cell disease","volume":"376","author":"Rees","year":"2010","journal-title":"Lancet"},{"key":"ref2","doi-asserted-by":"publisher","first-page":"311","DOI":"10.1016\/S0140-6736(17)30193-9","article-title":"Sickle cell disease","volume":"390","author":"Ware","year":"2017","journal-title":"Lancet"},{"key":"ref3","doi-asserted-by":"publisher","first-page":"1561","DOI":"10.1056\/NEJMra1510865","article-title":"Sickle cell disease","volume":"376","author":"Piel","year":"2017","journal-title":"N Engl J Med"},{"key":"ref4","doi-asserted-by":"publisher","first-page":"121","DOI":"10.1056\/NEJMoa1813598","article-title":"Hydroxyurea for children with sickle cell Anemia in sub-Saharan Africa","volume":"380","author":"Tshilolo","year":"2019","journal-title":"N Engl J Med"},{"key":"ref5","doi-asserted-by":"publisher","first-page":"e195","DOI":"10.1016\/S2214-109X(15)00288-0","article-title":"Burden of sickle cell trait and disease in the Uganda sickle surveillance study (US3): a cross-sectional study","volume":"4","author":"Ndeezi","year":"2016","journal-title":"Lancet Glob Health"},{"key":"ref6","doi-asserted-by":"publisher","first-page":"1073","DOI":"10.1080\/17434440.2016.1254038","article-title":"Emerging point-of-care technologies for sickle cell disease screening and monitoring","volume":"13","author":"Alapan","year":"2016","journal-title":"Expert Rev Med Devices"},{"key":"ref7","doi-asserted-by":"publisher","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":"ref8","doi-asserted-by":"publisher","first-page":"639208","DOI":"10.3389\/fmed.2021.639208","article-title":"Evaluation of microchip-based point-of-care device \"gazelle\" for diagnosis of sickle cell disease in India","volume":"8","author":"Shrivas","year":"2021","journal-title":"Front Med (Lausanne)"},{"key":"ref9","doi-asserted-by":"publisher","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":"ref10","article-title":"Evaluation of precision of quantitative measurement procedures","year":"2025","journal-title":"Clinical and Laboratory Standards Institute"},{"key":"ref11","article-title":"Evaluation of linearity of quantitative measurement procedures","year":"2020","journal-title":"Clinical and Laboratory Standards Institute"},{"key":"ref12","volume-title":"510(k) Substantial Equivalence Determination Decision Summary: CAPI 3 HEMOGLOBIN(E), K180762","author":"FDA","year":"2018"},{"key":"ref13","article-title":"Measurement procedure comparison and Bias estimation using patient samples. CLSI guideline","year":"2018","journal-title":"Clinical and Laboratory Standards Institute"},{"key":"ref14","first-page":"S49","article-title":"Limit of blank, limit of detection and limit of quantitation","volume":"29","author":"Armbruster","year":"2008","journal-title":"Clin Biochem Rev"},{"key":"ref15","doi-asserted-by":"publisher","first-page":"237","DOI":"10.1093\/clinchem\/45.2.237","article-title":"Evaluation of a capillary electrophoresis method for routine determination of hemoglobins A2 and F","volume":"45","author":"Cotton","year":"1999","journal-title":"Clin Chem"},{"key":"ref16","doi-asserted-by":"publisher","first-page":"50","DOI":"10.1016\/j.cca.2014.10.006","article-title":"Advances in detection of hemoglobinopathies","volume":"439","author":"Greene","year":"2015","journal-title":"Clin Chim Acta"},{"key":"ref17","article-title":"Gazelle Hb variant physician\u2019s guide","author":"Health","year":"","journal-title":"Hemex Health"}],"container-title":["Frontiers in Medicine"],"original-title":[],"link":[{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/fmed.2026.1903717\/full","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,9,22]],"date-time":"2026-09-22T04:26:52Z","timestamp":1790051212000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/fmed.2026.1903717\/full"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,9,22]]},"references-count":17,"alternative-id":["10.3389\/fmed.2026.1903717"],"URL":"https:\/\/doi.org\/10.3389\/fmed.2026.1903717","relation":{},"ISSN":["2296-858X"],"issn-type":[{"value":"2296-858X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,9,22]]},"article-number":"1903717"}}