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 ( = 78), sickle cell trait ( = 21), and sickle cell disease ( = 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.