Application of Realtime RT-PCR assay for the detection of E gene of SARS-CoV-2

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). 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