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Performances of four Nucleic Acid Amplification Tests for the identification of SARS-CoV-2 in Ethiopia

Since Coronavirus Disease-2019 (COVID-19) outbreak was reported, many commercial Nucleic Acid Amplification Tests (NAAT) have been developed all over the world, and it has been the standard method. Even though several assays were rapidly developed and applied to laboratory diagnostic testing, the pe...

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Autores principales: Hailemariam, Belete Woldesemayat, Zealiyas, Kidist, Gutema, Gadissa, Gebremicael, Gebremedhin, Adane, Sisay, Tadele, Sisay, Tayachew, Adamu, Araya, Shambel, Desta, Kassu
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Nature Publishing Group UK 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9700788/
https://www.ncbi.nlm.nih.gov/pubmed/36434013
http://dx.doi.org/10.1038/s41598-022-24411-2
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author Hailemariam, Belete Woldesemayat
Zealiyas, Kidist
Gutema, Gadissa
Gebremicael, Gebremedhin
Adane, Sisay
Tadele, Sisay
Tayachew, Adamu
Araya, Shambel
Desta, Kassu
author_facet Hailemariam, Belete Woldesemayat
Zealiyas, Kidist
Gutema, Gadissa
Gebremicael, Gebremedhin
Adane, Sisay
Tadele, Sisay
Tayachew, Adamu
Araya, Shambel
Desta, Kassu
author_sort Hailemariam, Belete Woldesemayat
collection PubMed
description Since Coronavirus Disease-2019 (COVID-19) outbreak was reported, many commercial Nucleic Acid Amplification Tests (NAAT) have been developed all over the world, and it has been the standard method. Even though several assays were rapidly developed and applied to laboratory diagnostic testing, the performance of these assays was not evaluated in different contexts. Thus, this study aimed to assess the performance of Abbott SARS-CoV-2, Daan Gene, BGI and Sansure Biotech assays by using Composite Reference Standard (CRS). The study was conducted at the Ethiopian Public Health Institute (EPHI) from December 1 to 30/2020. Of the 164 nasopharyngeal samples were extracted by using a QIAamp RNA mini kit and Abbott DNA sample preparation system. Out of 164 samples, 59.1% were positive and 40.9% were negative by CRS. Sansure Biotech positivity was significantly low compared to CRS (p < 0.05). The overall agreement of the four assays compared to CRS was 96.3–100%. The performance of the four assays had almost comparable diagnostic performance, except for a low positive rate of Sansure Biotech assay. Hence, Sansure Biotech assay [Research Use Only (RUO)] needs further verification on its use in Ethiopia. Finally an additional study should be considered for evaluating assays with respective manufacturer claims.
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spelling pubmed-97007882022-11-27 Performances of four Nucleic Acid Amplification Tests for the identification of SARS-CoV-2 in Ethiopia Hailemariam, Belete Woldesemayat Zealiyas, Kidist Gutema, Gadissa Gebremicael, Gebremedhin Adane, Sisay Tadele, Sisay Tayachew, Adamu Araya, Shambel Desta, Kassu Sci Rep Article Since Coronavirus Disease-2019 (COVID-19) outbreak was reported, many commercial Nucleic Acid Amplification Tests (NAAT) have been developed all over the world, and it has been the standard method. Even though several assays were rapidly developed and applied to laboratory diagnostic testing, the performance of these assays was not evaluated in different contexts. Thus, this study aimed to assess the performance of Abbott SARS-CoV-2, Daan Gene, BGI and Sansure Biotech assays by using Composite Reference Standard (CRS). The study was conducted at the Ethiopian Public Health Institute (EPHI) from December 1 to 30/2020. Of the 164 nasopharyngeal samples were extracted by using a QIAamp RNA mini kit and Abbott DNA sample preparation system. Out of 164 samples, 59.1% were positive and 40.9% were negative by CRS. Sansure Biotech positivity was significantly low compared to CRS (p < 0.05). The overall agreement of the four assays compared to CRS was 96.3–100%. The performance of the four assays had almost comparable diagnostic performance, except for a low positive rate of Sansure Biotech assay. Hence, Sansure Biotech assay [Research Use Only (RUO)] needs further verification on its use in Ethiopia. Finally an additional study should be considered for evaluating assays with respective manufacturer claims. Nature Publishing Group UK 2022-11-24 /pmc/articles/PMC9700788/ /pubmed/36434013 http://dx.doi.org/10.1038/s41598-022-24411-2 Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) .
spellingShingle Article
Hailemariam, Belete Woldesemayat
Zealiyas, Kidist
Gutema, Gadissa
Gebremicael, Gebremedhin
Adane, Sisay
Tadele, Sisay
Tayachew, Adamu
Araya, Shambel
Desta, Kassu
Performances of four Nucleic Acid Amplification Tests for the identification of SARS-CoV-2 in Ethiopia
title Performances of four Nucleic Acid Amplification Tests for the identification of SARS-CoV-2 in Ethiopia
title_full Performances of four Nucleic Acid Amplification Tests for the identification of SARS-CoV-2 in Ethiopia
title_fullStr Performances of four Nucleic Acid Amplification Tests for the identification of SARS-CoV-2 in Ethiopia
title_full_unstemmed Performances of four Nucleic Acid Amplification Tests for the identification of SARS-CoV-2 in Ethiopia
title_short Performances of four Nucleic Acid Amplification Tests for the identification of SARS-CoV-2 in Ethiopia
title_sort performances of four nucleic acid amplification tests for the identification of sars-cov-2 in ethiopia
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9700788/
https://www.ncbi.nlm.nih.gov/pubmed/36434013
http://dx.doi.org/10.1038/s41598-022-24411-2
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