Evaluation of Microchip-Based Point-Of-Care Device “Gazelle” for Diagnosis of Sickle Cell Disease in India

Abstract

Sickle cell disease is a major public health problem in India. Lack of rapid and reliable diagnostic methods result in many avoidable deaths in affected population. Current diagnostic tools are laboratory based, expensive and need trained manpower. Here, we evaluated the performance of a microchip-based cellulose acetate electrophoresis test, “Gazelle” in the tribal-dominated Indian states of Chhattisgarh and Madhya Pradesh. A total of 1,050 patients were screened by sickle cell solubility, hemoglobin (cellulose acetate) electrophoresis, high-performance liquid chromatography (HPLC) and Gazelle. Of the total 1,027 test results obtained, 960 tests were “Valid” (93.5%) and included in the analysis. Gazelle identified all patients with disease (HbSS and Thalassemia Major) with 100% accuracy. Gazelle demonstrated 100% sensitivity when comparing sickle cell disease (SCD) vs. sickle cell trait and SCD vs. normal. Specificity was 98.9% and 99.5% when comparing SCD vs. trait and trait vs. normal, respectively. Specificity was 99.8% when comparing SCD vs. normal and sensitivity was 99.3% when comparing trait vs. normal. Overall, Gazelle yielded a high accuracy (99.0%) compared to reference standard tests (hemoglobin electrophoresis and HPLC). Gazelle is a low-cost, rapid diagnostic test with high accuracy for detecting SCD both quantitatively and qualitatively. Gazelle can be a potential screening tool for the rapid diagnosis in resource limited settings and developing countries with high burden of hemoglobin disorders.

Evaluation of a point-of-care haemozoin assay (Gazelle device) for rapid detection of Plasmodium knowlesi malaria

“…In addition to detection of malaria based on paramagnetic properties of hemozoin crystals, the current iteration of the Gazelle™ has a separate slot for identifying common haemoglobin variants 42 using cellulose acetate-based cartridges on a microchip electrophoresis platform. This device has been evaluated for point-ofcare screening for other blood-related diseases and hemoglobinopathies such as sickle cell 43,44 and thalassemia 44 traits. In malaria endemic areas with a high prevalence of thalassaemia, a single strategically placed device may be able to perform routine screening of thalassemia in addition to rapid detection of clinical malaria infections, thus maximizing its cost-effectiveness in the field.…”

Odisha tribal family health survey: methods, tools, and protocols for a comprehensive health assessment survey

“…Among adult and adolescent participants, blood pressure will be measured (average of 3 readings) using automated digital blood pressure measuring machines and random blood glucose will be tested using a digital glucometer. Screening for hemoglobinopathies (sickle cell disease, trait and thalassemia)will be performed using a validated point-of-care device that uses a microchip-based cellulose acetate electrophoresis test for hemoglobin variant detection ( 15 ). The detailed procedures for all the household-level tests and sample handling are mentioned in the MOP, and the laboratory technicians would undergo comprehensive hands-on training before fieldwork.…”

Performance of Gazelle COVID-19 point-of-care test for detection of nucleocapsid antigen from SARS-CoV-2

“…The Gazelle COVID-19 Test is a fluorescent lateral flow immunoassay (FIA) for the qualitative detection of nucleocapsid antigen from SARS-CoV-2. The Gazelle platform includes a Reader which is capable of reading both colorimetric and certain fluorescent lateral flow assays and is adapted from the commercially available hemoglobin variant reader, using derived image-recognition software [10]. Here, we present the results from an observational study to assess the diagnostic performance of Gazelle Covid-19 Test, compared to RT-PCR.…”