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Clinical evaluation of SARS-CoV-2 antigen-based rapid diagnostic test kit for detection of COVID-19 cases in Bangladesh

The rapid and early detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections is key to control the current Coronavirus disease 2019 (COVID-19) pandemic. The present study was conducted to clinically evaluate a rapid diagnostic test (RDT) kit, Standard Q COVID-19 Ag Test (...

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Autores principales: Rahman, Md. Mahfuzur, Hoque, Ananya Ferdous, Karim, Yeasir, Kawser, Zannat, Siddik, Abu Bakar, Sumiya, Mariya Kibtiya, Siddika, Ayesha, Alam, Md. Shaheen, Alam, Ahmed Nawsher, Alam, Muntasir, Hossain, Mohammad Enayet, Banu, Sayera, Qadri, Firdausi, Shirin, Tahmina, Rahman, Mustafizur, Rahman, Mohammed Ziaur
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8606316/
https://www.ncbi.nlm.nih.gov/pubmed/34841119
http://dx.doi.org/10.1016/j.heliyon.2021.e08455
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author Rahman, Md. Mahfuzur
Hoque, Ananya Ferdous
Karim, Yeasir
Kawser, Zannat
Siddik, Abu Bakar
Sumiya, Mariya Kibtiya
Siddika, Ayesha
Alam, Md. Shaheen
Alam, Ahmed Nawsher
Alam, Muntasir
Hossain, Mohammad Enayet
Banu, Sayera
Qadri, Firdausi
Shirin, Tahmina
Rahman, Mustafizur
Rahman, Mohammed Ziaur
author_facet Rahman, Md. Mahfuzur
Hoque, Ananya Ferdous
Karim, Yeasir
Kawser, Zannat
Siddik, Abu Bakar
Sumiya, Mariya Kibtiya
Siddika, Ayesha
Alam, Md. Shaheen
Alam, Ahmed Nawsher
Alam, Muntasir
Hossain, Mohammad Enayet
Banu, Sayera
Qadri, Firdausi
Shirin, Tahmina
Rahman, Mustafizur
Rahman, Mohammed Ziaur
author_sort Rahman, Md. Mahfuzur
collection PubMed
description The rapid and early detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections is key to control the current Coronavirus disease 2019 (COVID-19) pandemic. The present study was conducted to clinically evaluate a rapid diagnostic test (RDT) kit, Standard Q COVID-19 Ag Test (SD Biosensor®, Republic of Korea), with reference to the standard real-time RT-PCR for detection of COVID-19 cases in Bangladesh. Nasopharyngeal swabs were taken from 900 COVID-19 suspected patients. Among them, 34.11% (n = 307) were diagnosed as COVID-19 cases by RT-PCR assay, of which 85% (n = 261) were also detectable using the RDT. The overall sensitivity and specificity of the RDT compared to RT-PCR were 85.02% and 100%, respectively, regardless of age, sex, and type of SARS-CoV-2 variants. Most of the RT-PCR positive cases (94%) were found within the first five days of disease onset, and the sensitivity of RDT was 85.91% for the same samples. The positive predictive value (PPV) of the RDT was 100%, and the negative predictive value (NPV) was 92.8%. The Cohen's kappa value of 0.882 indicated excellent agreement between the RDT and RT-PCR assays. The findings of this study showed the potential use of SARS-CoV-2 antigen-based RDT to expedite the diagnostic process and onward COVID-19 management in Bangladesh.
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spelling pubmed-86063162021-11-22 Clinical evaluation of SARS-CoV-2 antigen-based rapid diagnostic test kit for detection of COVID-19 cases in Bangladesh Rahman, Md. Mahfuzur Hoque, Ananya Ferdous Karim, Yeasir Kawser, Zannat Siddik, Abu Bakar Sumiya, Mariya Kibtiya Siddika, Ayesha Alam, Md. Shaheen Alam, Ahmed Nawsher Alam, Muntasir Hossain, Mohammad Enayet Banu, Sayera Qadri, Firdausi Shirin, Tahmina Rahman, Mustafizur Rahman, Mohammed Ziaur Heliyon Research Article The rapid and early detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections is key to control the current Coronavirus disease 2019 (COVID-19) pandemic. The present study was conducted to clinically evaluate a rapid diagnostic test (RDT) kit, Standard Q COVID-19 Ag Test (SD Biosensor®, Republic of Korea), with reference to the standard real-time RT-PCR for detection of COVID-19 cases in Bangladesh. Nasopharyngeal swabs were taken from 900 COVID-19 suspected patients. Among them, 34.11% (n = 307) were diagnosed as COVID-19 cases by RT-PCR assay, of which 85% (n = 261) were also detectable using the RDT. The overall sensitivity and specificity of the RDT compared to RT-PCR were 85.02% and 100%, respectively, regardless of age, sex, and type of SARS-CoV-2 variants. Most of the RT-PCR positive cases (94%) were found within the first five days of disease onset, and the sensitivity of RDT was 85.91% for the same samples. The positive predictive value (PPV) of the RDT was 100%, and the negative predictive value (NPV) was 92.8%. The Cohen's kappa value of 0.882 indicated excellent agreement between the RDT and RT-PCR assays. The findings of this study showed the potential use of SARS-CoV-2 antigen-based RDT to expedite the diagnostic process and onward COVID-19 management in Bangladesh. Elsevier 2021-11-22 /pmc/articles/PMC8606316/ /pubmed/34841119 http://dx.doi.org/10.1016/j.heliyon.2021.e08455 Text en © 2021 The Authors https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
spellingShingle Research Article
Rahman, Md. Mahfuzur
Hoque, Ananya Ferdous
Karim, Yeasir
Kawser, Zannat
Siddik, Abu Bakar
Sumiya, Mariya Kibtiya
Siddika, Ayesha
Alam, Md. Shaheen
Alam, Ahmed Nawsher
Alam, Muntasir
Hossain, Mohammad Enayet
Banu, Sayera
Qadri, Firdausi
Shirin, Tahmina
Rahman, Mustafizur
Rahman, Mohammed Ziaur
Clinical evaluation of SARS-CoV-2 antigen-based rapid diagnostic test kit for detection of COVID-19 cases in Bangladesh
title Clinical evaluation of SARS-CoV-2 antigen-based rapid diagnostic test kit for detection of COVID-19 cases in Bangladesh
title_full Clinical evaluation of SARS-CoV-2 antigen-based rapid diagnostic test kit for detection of COVID-19 cases in Bangladesh
title_fullStr Clinical evaluation of SARS-CoV-2 antigen-based rapid diagnostic test kit for detection of COVID-19 cases in Bangladesh
title_full_unstemmed Clinical evaluation of SARS-CoV-2 antigen-based rapid diagnostic test kit for detection of COVID-19 cases in Bangladesh
title_short Clinical evaluation of SARS-CoV-2 antigen-based rapid diagnostic test kit for detection of COVID-19 cases in Bangladesh
title_sort clinical evaluation of sars-cov-2 antigen-based rapid diagnostic test kit for detection of covid-19 cases in bangladesh
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8606316/
https://www.ncbi.nlm.nih.gov/pubmed/34841119
http://dx.doi.org/10.1016/j.heliyon.2021.e08455
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