# Feasibility analysis of the SICKLECHECK™ test kit for rapid screening of sickle cell disease at a County Referral Hospital in Kenya

## TL;DR

This study tested the SICKLECHECK™ rapid test for sickle cell disease in Kenya and found it highly accurate for identifying the condition and its variants.

## Contribution

The study provides empirical validation of the SICKLECHECK™ test's diagnostic performance in a real-world clinical setting in Kenya.

## Key findings

- The SICKLECHECK™ test showed over 97% sensitivity, specificity, and accuracy for detecting sickle cell disease.
- It effectively distinguished between normal, carrier, and disease phenotypes with high predictive values.
- The test is recommended for use in resource-limited settings for routine screening and diagnosis.

## Abstract

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.

This study evaluated the feasibility of using the SICKLECHECK™ rapid test kit for detecting sickle cell disease at Bungoma County Referral Hospital, Kenya.

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.

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.

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.

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.