A Rapid Qualitative Point-of-Care Testing Device for Diagnosis of Sickle Cell Disorders

Abstract

Background: Sickle cell disease (SCD) is a major hereditary hemoglobinopathy with high prevalence in central and southern India. Early detection remains a challenge in low-resource settings due to the dependence on expensive diagnostic systems such as high-performance liquid chromatography (HPLC) and electrophoresis. There is a global need for rapid, affordable point-of-care (POC) tests.
Objective: To develop, validate, and clinically evaluate a rapid, cost-effective lateral flow immunoassay (LFIA)–based diagnostic device (Biocard® Sickle Cell Rapid Test) for the detection of hemoglobin variants HbA and HbS
Methods: The study employed laboratory development of colloidal-gold-based LFIA, followed by analytical validation, reproducibility studies, inter- and intra-assay precision testing, accelerated and real-time stability evaluations, and analytical sensitivity/specificity assessment across three lots. A total of 290 pre-characterized clinical samples were evaluated at ICMR-NIIH and ICMR-CRMCH.
Results: The LFIA device showed >95% reproducibility and precision across three reagent lots. It reliably detected HbS at 1–2% concentration. Analytical specificity showed no cross-reactivity with HbF or other variants. Stability testing confirmed 27-month real-time stability at room-temperature. Clinical evaluation against HPLC demonstrated 100% sensitivity, 100% specificity, and 100% concordance across HbAA, HbAS, and HbSS patterns. Only 2.41% of HbSS samples showed faint adult Hb (A-band), likely due to transfusion or hemolysis.
Conclusion: The Biocard® Sickle Cell Rapid Test provides a robust, low-cost, and rapid diagnostic alternative suitable for POC settings, particularly in regions lacking laboratory infrastructure. Its excellent concordance with HPLC supports its integration into screening programs and resource-limited clinical settings.