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

IF 1.2 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

African Journal of Laboratory Medicine Pub Date : 2025-07-29 eCollection Date: 2025-01-01 DOI:10.4102/ajlm.v14i1.2739

Antony S Katayi, Phidelis M Marabi, Stanslaus K Musyoki

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Abstract

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.

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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

背景：肯尼亚西部镰状细胞病的负担是巨大的；然而，对这种疾病的快速诊断测试的有效性的研究有限。目的：本研究评估了在肯尼亚邦戈马县转诊医院使用SICKLECHECK™快速检测试剂盒检测镰状细胞病的可行性。方法：在2023年10月至2024年2月期间进行了一项横断面研究，包括健康儿童和已知血红蛋白表型的儿童。将SICKLECHECK™快速筛选试验与Bio-Rad™高效液相色谱法进行比较，后者作为参比标准。使用MedCalc™统计软件计算敏感性、特异性、阳性预测值、阴性预测值和总体准确性。结果：该研究涉及194名儿童（98名女孩和96名男孩），年龄在10周到15岁之间，血红蛋白呈镰状细胞阴性（n = 78），镰状细胞特征（n = 21）和镰状细胞病（n = 95）。SICKLECHECK™检测的敏感性、特异性、阴性预测值和准确性均超过97%，其中对血红蛋白a的阳性预测值为94.18%。该检测还能有效区分正常（敏感性97.44%，特异性99.14%）、携带者（敏感性90.48%，特异性98.27%）和疾病（敏感性98.95%，特异性98.99%）表型。结论：基于本研究的发现，SICKLECHECK™可作为镰状细胞病可靠的即时诊断工具。建议鼓励医疗机构，特别是在资源有限的环境中，采用SICKLECHECK™快速检测镰状细胞病的常规筛查和诊断。本研究补充：本研究强调了SICKLECHECK™快速检测在准确识别和区分镰状细胞病、特征和正常血红蛋白表型方面的诊断可靠性，加强了其在加强临床早期诊断工作中的潜在作用。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

African Journal of Laboratory Medicine MEDICINE, RESEARCH & EXPERIMENTAL-

CiteScore

1.70

自引率

9.10%

发文量

审稿时长

12 weeks

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.