Antony S Katayi, Phidelis M Marabi, Stanslaus K Musyoki
{"title":"肯尼亚某县转诊医院用于镰状细胞病快速筛查的SICKLECHECK™检测试剂盒的可行性分析","authors":"Antony S Katayi, Phidelis M Marabi, Stanslaus K Musyoki","doi":"10.4102/ajlm.v14i1.2739","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>The 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.</p><p><strong>Objective: </strong>This study evaluated the feasibility of using the SICKLECHECK™ rapid test kit for detecting sickle cell disease at Bungoma County Referral Hospital, Kenya.</p><p><strong>Methods: </strong>A 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™ rapid screening test was compared to Bio-Rad<sup>™</sup> high-performance liquid chromatography, which served as the reference standard. Sensitivity, specificity, positive predictive value, negative predictive value, and overall accuracy were calculated using MedCalc<sup>™</sup> statistical software.</p><p><strong>Results: </strong>The study involved 194 children (98 girls and 96 boys), aged between 10 weeks and 15 years, with haemoglobin profiles sickle cell negative (<i>n</i> = 78), sickle cell trait (<i>n</i> = 21), and sickle cell disease (<i>n</i> = 95). The SICKLECHECK™ 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.</p><p><strong>Conclusion: </strong>Based on the findings in this study, SICKLECHECK<sup>™</sup> could 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<sup>™</sup> rapid test for routine screening and diagnosis of sickle cell disease is recommended.</p><p><strong>What this study adds: </strong>This study highlights the diagnostic reliability of the SICKLECHECK<sup>™</sup> rapid 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.</p>","PeriodicalId":45412,"journal":{"name":"African Journal of Laboratory Medicine","volume":"14 1","pages":"2739"},"PeriodicalIF":1.2000,"publicationDate":"2025-07-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12339871/pdf/","citationCount":"0","resultStr":"{\"title\":\"Feasibility analysis of the SICKLECHECK™ test kit for rapid screening of sickle cell disease at a County Referral Hospital in Kenya.\",\"authors\":\"Antony S Katayi, Phidelis M Marabi, Stanslaus K Musyoki\",\"doi\":\"10.4102/ajlm.v14i1.2739\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>The 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.</p><p><strong>Objective: </strong>This study evaluated the feasibility of using the SICKLECHECK™ rapid test kit for detecting sickle cell disease at Bungoma County Referral Hospital, Kenya.</p><p><strong>Methods: </strong>A 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™ rapid screening test was compared to Bio-Rad<sup>™</sup> high-performance liquid chromatography, which served as the reference standard. Sensitivity, specificity, positive predictive value, negative predictive value, and overall accuracy were calculated using MedCalc<sup>™</sup> statistical software.</p><p><strong>Results: </strong>The study involved 194 children (98 girls and 96 boys), aged between 10 weeks and 15 years, with haemoglobin profiles sickle cell negative (<i>n</i> = 78), sickle cell trait (<i>n</i> = 21), and sickle cell disease (<i>n</i> = 95). The SICKLECHECK™ 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.</p><p><strong>Conclusion: </strong>Based on the findings in this study, SICKLECHECK<sup>™</sup> could 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<sup>™</sup> rapid test for routine screening and diagnosis of sickle cell disease is recommended.</p><p><strong>What this study adds: </strong>This study highlights the diagnostic reliability of the SICKLECHECK<sup>™</sup> rapid 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.</p>\",\"PeriodicalId\":45412,\"journal\":{\"name\":\"African Journal of Laboratory Medicine\",\"volume\":\"14 1\",\"pages\":\"2739\"},\"PeriodicalIF\":1.2000,\"publicationDate\":\"2025-07-29\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12339871/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"African Journal of Laboratory Medicine\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.4102/ajlm.v14i1.2739\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2025/1/1 0:00:00\",\"PubModel\":\"eCollection\",\"JCR\":\"Q4\",\"JCRName\":\"MEDICINE, RESEARCH & EXPERIMENTAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"African Journal of Laboratory Medicine","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.4102/ajlm.v14i1.2739","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/1/1 0:00:00","PubModel":"eCollection","JCR":"Q4","JCRName":"MEDICINE, RESEARCH & EXPERIMENTAL","Score":null,"Total":0}
Feasibility analysis of the SICKLECHECK™ test kit for rapid screening of sickle cell disease at a County Referral Hospital in Kenya.
Background: The 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: This study evaluated the feasibility of using the SICKLECHECK™ rapid test kit for detecting sickle cell disease at Bungoma County Referral Hospital, Kenya.
Methods: A 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™ rapid screening test was compared to Bio-Rad™ high-performance liquid chromatography, which served as the reference standard. Sensitivity, specificity, positive predictive value, negative predictive value, and overall accuracy were calculated using MedCalc™ statistical software.
Results: The study involved 194 children (98 girls and 96 boys), aged between 10 weeks and 15 years, with haemoglobin profiles sickle cell negative (n = 78), sickle cell trait (n = 21), and sickle cell disease (n = 95). The SICKLECHECK™ 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: Based on the findings in this study, SICKLECHECK™ could 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™ rapid test for routine screening and diagnosis of sickle cell disease is recommended.
What this study adds: This study highlights the diagnostic reliability of the SICKLECHECK™ rapid 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.
期刊介绍：
The African Journal of Laboratory Medicine, the official journal of ASLM, focuses on the role of the laboratory and its professionals in the clinical and public healthcare sectors,and is specifically based on an African frame of reference. Emphasis is on all aspects that promote and contribute to the laboratory medicine practices of Africa. This includes, amongst others: laboratories, biomedical scientists and clinicians, medical community, public health officials and policy makers, laboratory systems and policies (translation of laboratory knowledge, practices and technologies in clinical care), interfaces of laboratory with medical science, laboratory-based epidemiology, laboratory investigations, evidence-based effectiveness in real world (actual) settings.
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