Resumen

KATAYI, Antony S.; MARABI, Phidelis M.  y  MUSYOKI, Stanslaus K.. Feasibility analysis of the SICKLECHECK™ test kit for rapid screening of sickle cell disease at a County Referral Hospital in Kenya. Afr. J. Lab. Med. [online]. 2025, vol.14, n.1, pp.1-7. ISSN 2225-2010.  https://doi.org/10.4102/ajlm.v14i1.2739.

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.

Palabras clave : sickle cell disease; rapid test; testing; accuracy; Kenya.

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