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Diagnostic Performance of SARS-CoV-2 IgM/IgG Rapid Test Kits for the Detection of the Novel Coronavirus in Ethiopia

PURPOSE: Rapid severe acute respiratory syndrome coronavirus 2 test kits are crucial for bridging diagnostic gaps in health facilities and community screening mainly in resource limited settings. However, there is no objective evidence on their diagnostic performance. Thus, the study aimed to evalua...

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Autores principales: Sisay, Abay, Tesfaye, Abraham, Desale, Adino, Ataro, Israel, Woldesenbet, Zerihun, Nigusse, Bisrat, Tayachew, Adamu, Kebede, Adisu, Desta, Adey F
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Dove 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7850445/
https://www.ncbi.nlm.nih.gov/pubmed/33536760
http://dx.doi.org/10.2147/JMDH.S290711
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author Sisay, Abay
Tesfaye, Abraham
Desale, Adino
Ataro, Israel
Woldesenbet, Zerihun
Nigusse, Bisrat
Tayachew, Adamu
Kebede, Adisu
Desta, Adey F
author_facet Sisay, Abay
Tesfaye, Abraham
Desale, Adino
Ataro, Israel
Woldesenbet, Zerihun
Nigusse, Bisrat
Tayachew, Adamu
Kebede, Adisu
Desta, Adey F
author_sort Sisay, Abay
collection PubMed
description PURPOSE: Rapid severe acute respiratory syndrome coronavirus 2 test kits are crucial for bridging diagnostic gaps in health facilities and community screening mainly in resource limited settings. However, there is no objective evidence on their diagnostic performance. Thus, the study aimed to evaluate comparative diagnostic performance of three selected SARS-CoV-2 IgG/IgM rapid test kits in Ethiopia. METHODS: A cross-sectional study was conducted among 200 clients between May and July 2020 in Addis Ababa, Ethiopia. The performance of three SARS-CoV-2 rapid test kits EGENE, CTK BIOTECKs Onsite, and ACON Biotech were evaluated using blood specimens against RT-PCR on respiratory swabs. Sensitivity, specificity, and agreement with each other and to RT-PCR were computed using Vassarstats, MedCalc and SPSS version 23 statistical software. RESULTS: Test kits showed a heterogeneous comparative diagnostic performance in their sensitivity and specificity. The sensitivity was 61.18% (95% CI: 49.96–71.37%), 74.12% (95% CI: 63.28–82.74%) and 83.53% (95% CI: 73.57–90.38%) for kit A, B and C, respectively. Similarly, the specificity was 96.52% (90.81–98.88%), 94.78% (88.52–97.86%) and 94.78% (88.52–97.86%) for test kit A, B and C, respectively. The test kits have an agreement with RT-PCR with kappa value of 0.60 (0.48–0.83), 0.71 (0.65–0.93), and 0.80 (0.76–1.04) for A, B, and C, respectively. There was a significant difference on diagnostic performance among the three test kits and PCR with a p-value < 0.001 Cochran’s Q test. CONCLUSION: The diagnostic performance of the test kits was promising and recommended for COVID-19 diagnostics in combination with RT-PCR to detect more infected patients. It allows determining the seroprevalence of the virus and true extent of SARS-COV-2 community spread in resource limited settings. We underline countries to evaluate rapid diagnostic test kits before diagnostic use.
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spelling pubmed-78504452021-02-02 Diagnostic Performance of SARS-CoV-2 IgM/IgG Rapid Test Kits for the Detection of the Novel Coronavirus in Ethiopia Sisay, Abay Tesfaye, Abraham Desale, Adino Ataro, Israel Woldesenbet, Zerihun Nigusse, Bisrat Tayachew, Adamu Kebede, Adisu Desta, Adey F J Multidiscip Healthc Original Research PURPOSE: Rapid severe acute respiratory syndrome coronavirus 2 test kits are crucial for bridging diagnostic gaps in health facilities and community screening mainly in resource limited settings. However, there is no objective evidence on their diagnostic performance. Thus, the study aimed to evaluate comparative diagnostic performance of three selected SARS-CoV-2 IgG/IgM rapid test kits in Ethiopia. METHODS: A cross-sectional study was conducted among 200 clients between May and July 2020 in Addis Ababa, Ethiopia. The performance of three SARS-CoV-2 rapid test kits EGENE, CTK BIOTECKs Onsite, and ACON Biotech were evaluated using blood specimens against RT-PCR on respiratory swabs. Sensitivity, specificity, and agreement with each other and to RT-PCR were computed using Vassarstats, MedCalc and SPSS version 23 statistical software. RESULTS: Test kits showed a heterogeneous comparative diagnostic performance in their sensitivity and specificity. The sensitivity was 61.18% (95% CI: 49.96–71.37%), 74.12% (95% CI: 63.28–82.74%) and 83.53% (95% CI: 73.57–90.38%) for kit A, B and C, respectively. Similarly, the specificity was 96.52% (90.81–98.88%), 94.78% (88.52–97.86%) and 94.78% (88.52–97.86%) for test kit A, B and C, respectively. The test kits have an agreement with RT-PCR with kappa value of 0.60 (0.48–0.83), 0.71 (0.65–0.93), and 0.80 (0.76–1.04) for A, B, and C, respectively. There was a significant difference on diagnostic performance among the three test kits and PCR with a p-value < 0.001 Cochran’s Q test. CONCLUSION: The diagnostic performance of the test kits was promising and recommended for COVID-19 diagnostics in combination with RT-PCR to detect more infected patients. It allows determining the seroprevalence of the virus and true extent of SARS-COV-2 community spread in resource limited settings. We underline countries to evaluate rapid diagnostic test kits before diagnostic use. Dove 2021-01-27 /pmc/articles/PMC7850445/ /pubmed/33536760 http://dx.doi.org/10.2147/JMDH.S290711 Text en © 2021 Sisay et al. http://creativecommons.org/licenses/by-nc/3.0/ This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License (http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms (https://www.dovepress.com/terms.php).
spellingShingle Original Research
Sisay, Abay
Tesfaye, Abraham
Desale, Adino
Ataro, Israel
Woldesenbet, Zerihun
Nigusse, Bisrat
Tayachew, Adamu
Kebede, Adisu
Desta, Adey F
Diagnostic Performance of SARS-CoV-2 IgM/IgG Rapid Test Kits for the Detection of the Novel Coronavirus in Ethiopia
title Diagnostic Performance of SARS-CoV-2 IgM/IgG Rapid Test Kits for the Detection of the Novel Coronavirus in Ethiopia
title_full Diagnostic Performance of SARS-CoV-2 IgM/IgG Rapid Test Kits for the Detection of the Novel Coronavirus in Ethiopia
title_fullStr Diagnostic Performance of SARS-CoV-2 IgM/IgG Rapid Test Kits for the Detection of the Novel Coronavirus in Ethiopia
title_full_unstemmed Diagnostic Performance of SARS-CoV-2 IgM/IgG Rapid Test Kits for the Detection of the Novel Coronavirus in Ethiopia
title_short Diagnostic Performance of SARS-CoV-2 IgM/IgG Rapid Test Kits for the Detection of the Novel Coronavirus in Ethiopia
title_sort diagnostic performance of sars-cov-2 igm/igg rapid test kits for the detection of the novel coronavirus in ethiopia
topic Original Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7850445/
https://www.ncbi.nlm.nih.gov/pubmed/33536760
http://dx.doi.org/10.2147/JMDH.S290711
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