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

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-b...

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Autores principales: Shrivas, Shweta, Patel, Madhav, Kumar, Rajat, Gwal, Anil, Uikey, Ramswaroop, Tiwari, Shashi Kant, Verma, Anil Kumar, Thota, Priyaleela, Das, Aparup, Bharti, Praveen Kumar, Shanmugam, Rajasubramaniam
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8548372/
https://www.ncbi.nlm.nih.gov/pubmed/34722554
http://dx.doi.org/10.3389/fmed.2021.639208
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author Shrivas, Shweta
Patel, Madhav
Kumar, Rajat
Gwal, Anil
Uikey, Ramswaroop
Tiwari, Shashi Kant
Verma, Anil Kumar
Thota, Priyaleela
Das, Aparup
Bharti, Praveen Kumar
Shanmugam, Rajasubramaniam
author_facet Shrivas, Shweta
Patel, Madhav
Kumar, Rajat
Gwal, Anil
Uikey, Ramswaroop
Tiwari, Shashi Kant
Verma, Anil Kumar
Thota, Priyaleela
Das, Aparup
Bharti, Praveen Kumar
Shanmugam, Rajasubramaniam
author_sort Shrivas, Shweta
collection PubMed
description 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.
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spelling pubmed-85483722021-10-28 Evaluation of Microchip-Based Point-Of-Care Device “Gazelle” for Diagnosis of Sickle Cell Disease in India Shrivas, Shweta Patel, Madhav Kumar, Rajat Gwal, Anil Uikey, Ramswaroop Tiwari, Shashi Kant Verma, Anil Kumar Thota, Priyaleela Das, Aparup Bharti, Praveen Kumar Shanmugam, Rajasubramaniam Front Med (Lausanne) Medicine 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. Frontiers Media S.A. 2021-10-13 /pmc/articles/PMC8548372/ /pubmed/34722554 http://dx.doi.org/10.3389/fmed.2021.639208 Text en Copyright © 2021 Shrivas, Patel, Kumar, Gwal, Uikey, Tiwari, Verma, Thota, Das, Bharti and Shanmugam. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
spellingShingle Medicine
Shrivas, Shweta
Patel, Madhav
Kumar, Rajat
Gwal, Anil
Uikey, Ramswaroop
Tiwari, Shashi Kant
Verma, Anil Kumar
Thota, Priyaleela
Das, Aparup
Bharti, Praveen Kumar
Shanmugam, Rajasubramaniam
Evaluation of Microchip-Based Point-Of-Care Device “Gazelle” for Diagnosis of Sickle Cell Disease in India
title Evaluation of Microchip-Based Point-Of-Care Device “Gazelle” for Diagnosis of Sickle Cell Disease in India
title_full Evaluation of Microchip-Based Point-Of-Care Device “Gazelle” for Diagnosis of Sickle Cell Disease in India
title_fullStr Evaluation of Microchip-Based Point-Of-Care Device “Gazelle” for Diagnosis of Sickle Cell Disease in India
title_full_unstemmed Evaluation of Microchip-Based Point-Of-Care Device “Gazelle” for Diagnosis of Sickle Cell Disease in India
title_short Evaluation of Microchip-Based Point-Of-Care Device “Gazelle” for Diagnosis of Sickle Cell Disease in India
title_sort evaluation of microchip-based point-of-care device “gazelle” for diagnosis of sickle cell disease in india
topic Medicine
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8548372/
https://www.ncbi.nlm.nih.gov/pubmed/34722554
http://dx.doi.org/10.3389/fmed.2021.639208
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