DOI: 10.11648/j.ab.20261404.11 ISSN: 2329-0862

Performance Evaluation of the HemoTypeSC TM Rapid Screening Test for the Detection of Hemoglobin A, S, and C Variants at the Fann National University Hospital

Sene Ndep, Kandji Matar, Barry Kesso, Thioune Mareme, Ndiaye Siny, Djite Moustapha, Ndour Malick, Gueye-Tall Fatou, Gueye Madieye
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Hemoglobinopathies, particularly sickle cell disease, pose major public health challenges in resource-limited settings, where delayed diagnosis contributes to high morbidity and mortality. As the world's most common monogenic disorder, the vast majority of affected individuals reside in sub-Saharan Africa. This study evaluated the performance of the HemoTypeSC TM rapid test for detecting hemoglobin A, S, and C variants, in accordance with the NF EN ISO 15189 standard. A prospective analytical study was conducted at the Biochemistry-Hematology Laboratory of Fann National University Hospital Center. Patients referred for hemoglobin electrophoresis were tested using HemoTypeSC TM , with the Emmel test and capillary electrophoresis (Capillarys 3 octa, Sebia) as comparative methods. Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and overall agreement were calculated with 95% confidence intervals. Among the 126 samples, 19 had normal profiles and 107 had hemoglobinopathies. Compared with the Emmel test, HemoTypeSC TM showed 100% sensitivity and specificity. Compared with capillary electrophoresis, sensitivity was 98.16%, specificity 100%, PPV 100%, and NPV 90.48%. Two discrepancies in fine typing were observed among the 107 abnormal profiles, with no missed abnormal profiles. HemoTypeSC TM is a rapid, reliable, and easy-to-use test for first-line sickle cell disease screening in resource-limited settings. Positive results should be systematically confirmed by electrophoresis.

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