Journal Article

Evaluation of a point-of-care rapid diagnostic test kit (SICKLECHECK) for screening of sickle cell diseases

Purohit, Prasanta, Naik, Aparupa, Martha, Tapan Kumar, Parida, Chinmayee, Bholo, Snehal, Behera, Samira Kumar

2024

Overview

Sickle cell diseases (SCD) are the most common genetic disorders with significant morbidity and mortality worldwide, including in India. The high prevalence of this disorder in many geographical regions calls for the use of a point-of-care rapid diagnostic test (RDT) for early screening and management of the diagnosed cases to reduce the allied clinical severity. In view of this, the present study was undertaken for the validation of a point-of-care RDT kit (SICKLECHECK TM ) for the screening of SCD. This validation and diagnostic accuracy study was conducted among the cases advised for screening of SCD. For validation, all the recruited cases were investigated for both the SICKLECHECK TM RDT kit and HPLC (Variant-II) considering HPLC as a gold standard. A total of 400 cases were screened for both tests. For the presence and absence of sickle cell hemoglobin in the samples, SICKLECHECK TM RDT kit results showed a sensitivity and specificity of 99.39% and 98.73% respectively with references to HPLC findings. For the detection of the ‘AS’ pattern, the SICKLECHECK TM RDT kit has shown a sensitivity and specificity of 99.07% and 98.81% respectively. For the detection of the ‘SS’ pattern, the SICKLECHECK TM RDT kit has shown a sensitivity and specificity of 97.92% and 100.0% respectively. Cases with β thalassemia trait, hemoglobin E trait, hemoglobin Lepore trait and trait for hereditary-persistence-of-fetal-hemoglobin (high HbF %) diagnosed in HPLC were resulted with ‘AA’ pattern in SICKLECHECK TM RDT kit. The high sensitivity and specificity of the SICKLECHECK TM RDT kit insist on its use as a point-of-care screening tool for SCD especially where there is a lack of laboratory facilities as well as in hospital-based set-up requiring immediate diagnosis and management of SCD. However, for further confirmation, the samples should be analyzed with other gold standard techniques like HPLC.

• Publisher: Public Library of Science,Public Library of Science (PLoS)
• Subject: Accuracy / Adolescent / Adult / Anemia / Anemia, Sickle Cell - blood / Anemia, Sickle Cell - diagnosis / Anemia, Sickle Cell - epidemiology / Antigens / Blood diseases / Blood transfusions / Child / Chromatography, High Pressure Liquid - methods / Diagnosis / Diagnostic tests / Ethylenediaminetetraacetic acid / Female / Fetuses / Genetic disorders / Glycosylated hemoglobin / Health aspects / Hemoglobin / Hemoglobin, Sickle - analysis / Hemoglobin, Sickle - genetics / High performance liquid chromatography / Humans / India / Laboratories / Liquid chromatography / Male / Mass Screening - methods / Medical diagnosis / Medical screening / Medical testing products / Monoclonal antibodies / Morbidity / Mortality / Point of care testing / Point-of-Care Systems / Rapid Diagnostic Tests / Reagent Kits, Diagnostic / Sample size / Sensitivity and Specificity / Sickle cell anemia / Sickle cell disease / Thalassemia / Young Adult