{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,9,26]],"date-time":"2025-09-26T00:18:29Z","timestamp":1758845909992,"version":"3.44.0"},"reference-count":23,"publisher":"AOSIS","issue":"1","license":[{"start":{"date-parts":[[2025,7,29]],"date-time":"2025-07-29T00:00:00Z","timestamp":1753747200000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2025,7,29]],"date-time":"2025-07-29T00:00:00Z","timestamp":1753747200000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Afr. J. Lab. Med."],"abstract":"<jats:p>Background:\u00a0The burden of sickle cell disease in Western Kenya is substantial; however, there is limited research on the effectiveness of rapid diagnostic tests for the condition.Objective:\u00a0This study evaluated the feasibility of using the SICKLECHECK\u2122 rapid test kit for detecting sickle cell disease at Bungoma County Referral Hospital, Kenya.Methods:\u00a0A cross-sectional study was carried out between October 2023 and February 2024 and included both healthy children and children with a known haemoglobin phenotype. The SICKLECHECK\u2122 rapid screening test was compared to Bio-Rad\u2122\u00a0high-performance liquid chromatography, which served as the reference standard. Sensitivity, specificity, positive predictive value, negative predictive value, and overall accuracy were calculated using MedCalc\u2122\u00a0statistical software.Results:\u00a0The study involved 194 children (98 girls and 96 boys), aged between 10 weeks and 15 years, with haemoglobin profiles sickle cell negative (n\u00a0= 78), sickle cell trait (n\u00a0= 21), and sickle cell disease (n\u00a0= 95). The SICKLECHECK\u2122 test demonstrated sensitivity, specificity, negative predictive value, and accuracy exceeding 97%, with a positive predictive value of 94.18% for haemoglobin A. It also effectively distinguished between normal (sensitivity 97.44%, specificity 99.14%), carrier (sensitivity 90.48%, specificity 98.27%), and disease (sensitivity 98.95%, specificity 98.99%) phenotypes.Conclusion:\u00a0Based on the findings in this study, SICKLECHECK\u2122\u00a0could be a reliable point-of-care diagnostic tool for sickle cell disease. The encouragement of healthcare facilities, especially in resource-limited settings, to adopt the SICKLECHECK\u2122\u00a0rapid test for routine screening and diagnosis of sickle cell disease is recommended.What this study adds:\u00a0This study highlights the diagnostic reliability of the SICKLECHECK\u2122\u00a0rapid test in accurately identifying and differentiating sickle cell disease, trait, and normal haemoglobin phenotypes, reinforcing its potential role in strengthening early diagnosis efforts in clinical settings.<\/jats:p>","DOI":"10.4102\/ajlm.v14i1.2739","type":"journal-article","created":{"date-parts":[[2025,7,28]],"date-time":"2025-07-28T08:10:33Z","timestamp":1753690233000},"update-policy":"https:\/\/doi.org\/10.4102\/crossmark-policy","source":"Crossref","is-referenced-by-count":0,"title":["Feasibility analysis of the SICKLECHECK\u2122 test kit for rapid screening of sickle cell disease at a County Referral Hospital in Kenya"],"prefix":"10.4102","volume":"14","author":[{"ORCID":"https:\/\/orcid.org\/0009-0008-6991-0447","authenticated-orcid":false,"given":"Antony S.","family":"Katayi","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8300-8539","authenticated-orcid":false,"given":"Phidelis M.","family":"Marabi","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2900-9928","authenticated-orcid":false,"given":"Stanslaus K.","family":"Musyoki","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"2580","published-online":{"date-parts":[[2025,7,29]]},"reference":[{"key":"ref0","doi-asserted-by":"crossref","unstructured":"Egesa WI, Nakalema G, Waibi WM, et al. sickle cell disease in children and adolescents: A review of the historical, clinical, and public health perspective of sub-Saharan Africa and beyond. Int J Pediatr. 2022;2022:3885979. https:\/\/doi.org\/10.1155\/2022\/3885979","DOI":"10.1155\/2022\/3885979"},{"key":"ref1","doi-asserted-by":"crossref","unstructured":"Oron AP, Chao DL, Ezeanolue EE, et al. Caring for Africa\u2019s sickle cell children: Will we rise to the challenge? BMC Med. 2020;18:92. https:\/\/doi.org\/10.1186\/s12916-020-01557-2","DOI":"10.1186\/s12916-020-01557-2"},{"key":"ref2","doi-asserted-by":"crossref","unstructured":"Quinn CT, Paniagua MC, DiNello RK, Panchal A, Geisberg M. A rapid, inexpensive and disposable point-of-care blood test for sickle cell disease using novel, highly specific monoclonal antibodies. Br J Haematol. 2016;175(4):724\u2013732. https:\/\/doi.org\/10.1111\/bjh.14298","DOI":"10.1111\/bjh.14298"},{"key":"ref3","doi-asserted-by":"crossref","unstructured":"McGann PT, Hernandez AG, Ware RE. Sickle cell anemia in sub-Saharan Africa: Advancing the clinical paradigm through partnerships and research. Blood. 2017;129(2):155\u2013161. https:\/\/doi.org\/10.1182\/blood-2016-09-702324","DOI":"10.1182\/blood-2016-09-702324"},{"key":"ref4","doi-asserted-by":"crossref","unstructured":"Mutua B, Sowayi G, Okoth P. Distribution of hemoglobinopathy phenotypes in western Kenya: A retrospective study done at Aga Khan Hospital, Kisumu. Egypt J Intern Med. 2022;34(1):50. https:\/\/doi.org\/10.1186\/s43162-022-00138-4","DOI":"10.1186\/s43162-022-00138-4"},{"key":"ref5","doi-asserted-by":"crossref","unstructured":"Nwabuko OC, Onwuchekwa U, Iheji O. An overview of sickle cell disease from the socio-demographic triangle \u2013 A Nigerian single-institution retrospective study. Pan Afr Med J. 2022;41:161. https:\/\/doi.org\/10.11604\/pamj.2022.41.161.27117","DOI":"10.11604\/pamj.2022.41.161.27117"},{"key":"ref6","doi-asserted-by":"crossref","unstructured":"Ally M, Balandya E. Current challenges and new approaches to implementing optimal management of sickle cell disease in sub-Saharan Africa. Semin Hematol. 2023;60(4):192\u2013199. https:\/\/doi.org\/10.1053\/j.seminhematol.2023.08.002","DOI":"10.1053\/j.seminhematol.2023.08.002"},{"key":"ref7","doi-asserted-by":"crossref","unstructured":"Ilyas S, Simonson AE, Asghar W. Emerging point-of-care technologies for sickle cell disease diagnostics. Clin Chim Acta Int J Clin Chem. 2020;501:85\u201391. https:\/\/doi.org\/10.1016\/j.cca.2019.10.025","DOI":"10.1016\/j.cca.2019.10.025"},{"key":"ref8","unstructured":"Khisa T, Omwenga E, Emonyi WE. Sickle cell trait frequencies in blood donors and its effect among recipients in Bungoma County, Kenya. East Afr Med J. 2021;98:3916\u20133925."},{"key":"ref9","unstructured":"Kenya National Bureau Statistics (KNBS). Population and housing census [homepage on the Internet]. 2019 [cited 2024 Jan 16]. Available from: https:\/\/www.knbs.or.Ke\/2019-kenya-population-and-housing-census-results."},{"key":"ref10","unstructured":"BCRH. Bungoma County Referral Hospital patients\u2019 records register. 2020 (Unpublished)."},{"key":"ref11","doi-asserted-by":"crossref","unstructured":"Kim HY. Statistical notes for clinical researchers: Sample size calculation 2. Comparison of two independent proportions. Restor Dent Endod. 2016;41(2):154\u2013156. https:\/\/doi.org\/10.5395\/rde.2016.41.2.154","DOI":"10.5395\/rde.2016.41.2.154"},{"key":"ref12","doi-asserted-by":"crossref","unstructured":"Steele C, Sinski A, Asibey J, et al. Point-of-care screening for sickle cell disease in low-resource settings: A multi-center evaluation of HemoTypeSC, a novel rapid test. Am J Hematol. 2019;94(1):39\u201345. https:\/\/doi.org\/10.1002\/ajh.25305","DOI":"10.1002\/ajh.25305"},{"key":"ref13","doi-asserted-by":"crossref","unstructured":"Purohit P, Parida C, Martha TK, Bholo S, Naik A, Behera SK. Evaluation of a point-of-care rapid diagnostic test kit (Sickle Check) for screening of sickle cell diseases. PLoS One. 2024;19(8):e0309045. https:\/\/doi.org\/10.1371\/journal.pone.0309045","DOI":"10.1371\/journal.pone.0309045"},{"key":"ref14","doi-asserted-by":"crossref","unstructured":"Kanter J, Telen MJ, Hoppe C, Roberts CL, Kim JS, Yang X. Validation of a novel point of care testing device for sickle cell disease. BMC Med. 2015;13:225. https:\/\/doi.org\/10.1186\/s12916-015-0473-6","DOI":"10.1186\/s12916-015-0473-6"},{"key":"ref15","doi-asserted-by":"crossref","unstructured":"Nnodu O, Isa H, Nwegbu M, et al. HemoTypeSC, a low-cost point-of-care testing device for sickle cell disease: Promises and challenges. Blood Cells Mol Dis. 2019;78:22\u201328. https:\/\/doi.org\/10.1016\/j.bcmd.2019.01.007","DOI":"10.1016\/j.bcmd.2019.01.007"},{"key":"ref16","doi-asserted-by":"crossref","unstructured":"Bond M, Hunt B, Flynn B, Huhtinen P, Ware R, Richards-Kortum R. Towards a point-of-care strip test to diagnose sickle cell anemia. PLoS One. 2017;12(5):e0177732. https:\/\/doi.org\/10.1371\/journal.pone.0177732","DOI":"10.1371\/journal.pone.0177732"},{"key":"ref17","doi-asserted-by":"crossref","unstructured":"McGann PT, Schaefer BA, Paniagua M, Howard TA, Ware RE. Characteristics of a rapid, point-of-care lateral flow immunoassay for the diagnosis of sickle cell disease. Am J Hematol. 2016;91(2):205\u2013210. https:\/\/doi.org\/10.1002\/ajh.24232","DOI":"10.1002\/ajh.24232"},{"key":"ref18","doi-asserted-by":"crossref","unstructured":"Abbasi J. Study evaluates rapid sickle cell disease test. JAMA. 2019;322(22):2161. https:\/\/doi.org\/10.1001\/jama.2019.19606","DOI":"10.1001\/jama.2019.19606"},{"key":"ref19","doi-asserted-by":"crossref","unstructured":"Guindo A, Cisse Z, Keita I, et al. Potential for a large-scale newborn screening strategy for sickle cell disease in Mali: A comparative diagnostic performance study of two rapid diagnostic tests (SickleScan\u00ae and HemotypeSC\u00ae) on cord blood. Br J Haematol. 2024;204(1):337\u2013345. https:\/\/doi.org\/10.1111\/bjh.19108","DOI":"10.1111\/bjh.19108"},{"key":"ref20","doi-asserted-by":"crossref","unstructured":"Ndeezi G, Kiyaga C, Hernandez AG, et al. Burden of sickle cell trait and disease in the Uganda Sickle Surveillance Study (US3): A cross-sectional study. Lancet Glob Health. 2016;4(3):e195\u2013e200. https:\/\/doi.org\/10.1016\/S2214-109X(15)00288-0","DOI":"10.1016\/S2214-109X(15)00288-0"},{"key":"ref21","doi-asserted-by":"crossref","unstructured":"McGann PT, Hoppe C. The pressing need for point-of-care diagnostics for sickle cell disease: A review of current and future technologies. Blood Cells Mol Dis. 2017;67:104\u2013113. https:\/\/doi.org\/10.1016\/j.bcmd.2017.08.010","DOI":"10.1016\/j.bcmd.2017.08.010"},{"key":"ref22","doi-asserted-by":"crossref","unstructured":"Olatunya OS, Albuquerque DM, Fagbamigbe AF, et al. Diagnostic accuracy of HemotypeSC as a point-of-care testing device for sickle cell disease: Findings from a Southwestern State in Nigeria and implications for patient care in resource-poor settings of sub-Saharan Africa. 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