Rapid Development and Validation of a Novel Laboratory-Derived Test for the Detection of SARS-CoV-2.

ABSTRACT:

Objectives

To increase testing capability for SARS-CoV-2 during a rapidly evolving public health emergency, we aimed to deploy a validated laboratory-developed real-time reverse transcription polymerase chain reaction (RT-PCR) diagnostic test for SARS-CoV-2 on an accelerated timeline and using reagent supply chains that were not constrained.

Methods

A real-time RT-PCR assay that detects the structural envelope (E) gene of SARS-CoV-2 was developed and validated on the Roche cobas 6800 instrument platform with the omni Utility channel reagents, which performs automated nucleic acid extraction and purification, PCR amplification, and detection. In silico analysis was performed for both inclusivity of all SARS-CoV-2 variants and cross reactivity with other pathogen

SUBMITTER: Saylor J 

PROVIDER: S-EPMC8389818 | biostudies-literature | 2020 Jul

REPOSITORIES: biostudies-literature