Performances of four Nucleic Acid Amplification Tests for the identification of SARS-CoV-2 in Ethiopia
Abstract 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 testin...
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| Format: | Article |
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Nature Portfolio
2022-11-01
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| Series: | Scientific Reports |
| Online Access: | https://doi.org/10.1038/s41598-022-24411-2 |
| _version_ | 1811304605430054912 |
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| author | Belete Woldesemayat Hailemariam Kidist Zealiyas Gadissa Gutema Gebremedhin Gebremicael Sisay Adane Sisay Tadele Adamu Tayachew Shambel Araya Kassu Desta |
| author_facet | Belete Woldesemayat Hailemariam Kidist Zealiyas Gadissa Gutema Gebremedhin Gebremicael Sisay Adane Sisay Tadele Adamu Tayachew Shambel Araya Kassu Desta |
| author_sort | Belete Woldesemayat Hailemariam |
| collection | DOAJ |
| description | Abstract 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. |
| first_indexed | 2024-04-13T08:10:25Z |
| format | Article |
| id | doaj.art-7495b89d78cf4eefb9530b1d3f70208a |
| institution | Directory Open Access Journal |
| issn | 2045-2322 |
| language | English |
| last_indexed | 2024-04-13T08:10:25Z |
| publishDate | 2022-11-01 |
| publisher | Nature Portfolio |
| record_format | Article |
| series | Scientific Reports |
| spelling | doaj.art-7495b89d78cf4eefb9530b1d3f70208a2022-12-22T02:55:02ZengNature PortfolioScientific Reports2045-23222022-11-011211710.1038/s41598-022-24411-2Performances of four Nucleic Acid Amplification Tests for the identification of SARS-CoV-2 in EthiopiaBelete Woldesemayat Hailemariam0Kidist Zealiyas1Gadissa Gutema2Gebremedhin Gebremicael3Sisay Adane4Sisay Tadele5Adamu Tayachew6Shambel Araya7Kassu Desta8HIV/AIDS Disease Research Team, TB and HIV/AIDS Disease Research Directorate, Ethiopian Public Health InstituteHIV/AIDS Disease Research Team, TB and HIV/AIDS Disease Research Directorate, Ethiopian Public Health InstituteHIV/AIDS Disease Research Team, TB and HIV/AIDS Disease Research Directorate, Ethiopian Public Health InstituteHIV/AIDS Disease Research Team, TB and HIV/AIDS Disease Research Directorate, Ethiopian Public Health InstituteHIV/AIDS Disease Research Team, TB and HIV/AIDS Disease Research Directorate, Ethiopian Public Health InstituteHIV/AIDS Disease Research Team, TB and HIV/AIDS Disease Research Directorate, Ethiopian Public Health InstituteNational Influenza Reference Laboratory, Ethiopian Public Health InstituteDepartment of Medical Laboratory Sciences, College of Health Sciences, Addis Ababa UniversityDepartment of Medical Laboratory Sciences, College of Health Sciences, Addis Ababa UniversityAbstract 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.https://doi.org/10.1038/s41598-022-24411-2 |
| spellingShingle | Belete Woldesemayat Hailemariam Kidist Zealiyas Gadissa Gutema Gebremedhin Gebremicael Sisay Adane Sisay Tadele Adamu Tayachew Shambel Araya Kassu Desta Performances of four Nucleic Acid Amplification Tests for the identification of SARS-CoV-2 in Ethiopia Scientific Reports |
| 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 |
| url | https://doi.org/10.1038/s41598-022-24411-2 |
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