Establishment of an in-house real-time RT-PCR assay for the detection of severe acute respiratory syndrome coronavirus 2 using the first World Health Organization international standard in a resource-limited country.

ABSTRACT:

Background

The COVID-19 pandemic caused by SARS-CoV-2 remains public health burdens and many unresolved issues worldwide. Molecular assays based on real-time RT-PCR are critical for the detection of SARS-CoV-2 in clinical specimens from patients suspected of COVID-19.

Objective

We aimed to establish and validate an in-house real-time RT-PCR for the detection of SARS-CoV-2.

Methodology

Primers and probes sets in our in-house real-time RT-PCR assay were designed in conserved regions of the N and E target genes. Optimized multiplex real-time RT-PCR assay was validated using the first WHO International Standard (NIBSC code: 20/146) and evaluated clinical performance.

Results

The limit of detection validated using the first WHO International Standard was 159 IU/ml f

SUBMITTER: Nguyen LT 

PROVIDER: S-EPMC9102516 | biostudies-literature | 2022 May

REPOSITORIES: biostudies-literature