{"title":"实时RT-PCR检测SARS-CoV-2 E基因的应用","authors":"Dinh Thi Phuong Thao, V. T. Hương, P. Thuy","doi":"10.56086/jcvb.v2i3.68","DOIUrl":null,"url":null,"abstract":"Application on the Realtime RT-PCR assay is a method to determine the presence of viruses through the detection of genetic material of the SARS-CoV-2 virus, which is a highly accurate method. This study was conducted to validate the Realtime RT-PCR assay for the detection of E gene of SARS-CoV-2 at National Institute for Control of Vaccines and Biologicals (NICVB). \nDescriptive study in the laboratory. We determined limit of detection (LOD), reproducibility and analytical specificity of the Realtime RT-PCR assay for the detection of E gene of SARS-CoV-2 according WHO guidelines. \nThe study results included as follow the limit of detection (LOD) reached LOD 95 is 5.2 copies/reaction (95%CI 3.3- 8.0); The accuracy with mean CV (%) of repeatability reached 2.00% and reproducibility reached 1.74% and analytical specificity reached 100%. The results all met the approval criteria and comparable to published data by WHO group. \nBased on results we successful application of Realtime RT-PCR assay for the detection of E gene of SARS-CoV-2 at National Institute for Control of Vaccines and Biologicals","PeriodicalId":166965,"journal":{"name":"JOURNAL OF CONTROL VACCINE AND BIOLOGICALS","volume":"18 1","pages":"0"},"PeriodicalIF":0.0000,"publicationDate":"2022-10-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Application of Realtime RT-PCR assay for the detection of E gene of SARS-CoV-2\",\"authors\":\"Dinh Thi Phuong Thao, V. T. Hương, P. Thuy\",\"doi\":\"10.56086/jcvb.v2i3.68\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"Application on the Realtime RT-PCR assay is a method to determine the presence of viruses through the detection of genetic material of the SARS-CoV-2 virus, which is a highly accurate method. This study was conducted to validate the Realtime RT-PCR assay for the detection of E gene of SARS-CoV-2 at National Institute for Control of Vaccines and Biologicals (NICVB). \\nDescriptive study in the laboratory. We determined limit of detection (LOD), reproducibility and analytical specificity of the Realtime RT-PCR assay for the detection of E gene of SARS-CoV-2 according WHO guidelines. \\nThe study results included as follow the limit of detection (LOD) reached LOD 95 is 5.2 copies/reaction (95%CI 3.3- 8.0); The accuracy with mean CV (%) of repeatability reached 2.00% and reproducibility reached 1.74% and analytical specificity reached 100%. The results all met the approval criteria and comparable to published data by WHO group. \\nBased on results we successful application of Realtime RT-PCR assay for the detection of E gene of SARS-CoV-2 at National Institute for Control of Vaccines and Biologicals\",\"PeriodicalId\":166965,\"journal\":{\"name\":\"JOURNAL OF CONTROL VACCINE AND BIOLOGICALS\",\"volume\":\"18 1\",\"pages\":\"0\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2022-10-31\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"JOURNAL OF CONTROL VACCINE AND BIOLOGICALS\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.56086/jcvb.v2i3.68\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"JOURNAL OF CONTROL VACCINE AND BIOLOGICALS","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.56086/jcvb.v2i3.68","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
Application of Realtime RT-PCR assay for the detection of E gene of SARS-CoV-2
Application on the Realtime RT-PCR assay is a method to determine the presence of viruses through the detection of genetic material of the SARS-CoV-2 virus, which is a highly accurate method. This study was conducted to validate the Realtime RT-PCR assay for the detection of E gene of SARS-CoV-2 at National Institute for Control of Vaccines and Biologicals (NICVB).
Descriptive study in the laboratory. We determined limit of detection (LOD), reproducibility and analytical specificity of the Realtime RT-PCR assay for the detection of E gene of SARS-CoV-2 according WHO guidelines.
The study results included as follow the limit of detection (LOD) reached LOD 95 is 5.2 copies/reaction (95%CI 3.3- 8.0); The accuracy with mean CV (%) of repeatability reached 2.00% and reproducibility reached 1.74% and analytical specificity reached 100%. The results all met the approval criteria and comparable to published data by WHO group.
Based on results we successful application of Realtime RT-PCR assay for the detection of E gene of SARS-CoV-2 at National Institute for Control of Vaccines and Biologicals
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