Evaluating the performance of ErbaQik sickle cell rapid test card with HPLC method

Abstract

Sickle cell disease (SCD) is a hereditary hemoglobinopathy characterized by the presence of abnormal hemoglobin, primarily hemoglobin S (HbS), resulting from a point mutation in the β-globin gene. ErbaQik Sickle Cell Rapid Test Card developed by Transasia Diagnostics Pvt Ltd will aid in rapid detection of Sickle cell disease particularly in resource & laboratory infrastructure limited settings.To ensure the accuracy of ErbaQik Sickle Cell Rapid Test Card, a robust validation was conducted and compared with gold standard HPLC method to check the sensitivity, specificity, precision and clinical utility. This study was conducted under the guidance of Consultant Paediatrician, from Dec 2023 to Feb 2024 at Nagpur center run by Thalassemia and Sickle cell Society of India in collaboration with Rughwani Child Care Centre to evaluate the performance of ErbaQik Sickle Cell Rapid Test Card with HPLC method which is the benchmark for comparison in this study. A total of 181 blood samples were analyzed for hemoglobin variants. The evaluation of the ErbaQik Sickle Cell Rapid Test Card produced significant findings For Sickle-SS 32 samples were tested, all of which were correctly identified, yielding a sensitivity and specificity of 100%. Similarly 27 Trait-AS samples were all accurately detected, maintaining 100% sensitivity and specificity. These results indicate the test's high reliability and precision in identifying Sickle Cell Disease and Trait conditions. For Wild-Normal samples, the test was performed on 120 samples resulting in 100% sensitivity and specificity. In the case of Thalassemia samples, only 2 samples were tested, with 1 correctly identified, resulting in a sensitivity and specificity of 50%. The ErbaQik Sickle Cell Rapid Test Card demonstrated high sensitivity and specificity for detecting Sickle Cell Disease (SS) and Trait (AS), aligning with gold-standard methods like HPLC.