Detection of 2019 novel coronavirus (2019-nCoV) by real-time RT-PCR

TLDR

The 2019‑nCoV outbreak poses a challenge for public health labs due to lack of virus isolates, widespread transmission, and international spread, with control material provided by the European Virus Archive – Global. The study aimed to develop and deploy a robust diagnostic method for 2019‑nCoV that could be used in public health laboratories without access to virus material. The authors validated a diagnostic workflow that leverages the genetic similarity between 2019‑nCoV and SARS‑CoV, using synthetic nucleic acid technology. The workflow reliably detects 2019‑nCoV, discriminates it from SARS‑CoV, and was confirmed exclusive across 297 clinical specimens with diverse respiratory viruses, demonstrating the capacity of coordinated academic and public laboratory networks.

Abstract

Background The ongoing outbreak of the recently emerged novel coronavirus (2019-nCoV) poses a challenge for public health laboratories as virus isolates are unavailable while there is growing evidence that the outbreak is more widespread than initially thought, and international spread through travellers does already occur. Aim We aimed to develop and deploy robust diagnostic methodology for use in public health laboratory settings without having virus material available. Methods Here we present a validated diagnostic workflow for 2019-nCoV, its design relying on close genetic relatedness of 2019-nCoV with SARS coronavirus, making use of synthetic nucleic acid technology. Results The workflow reliably detects 2019-nCoV, and further discriminates 2019-nCoV from SARS-CoV. Through coordination between academic and public laboratories, we confirmed assay exclusivity based on 297 original clinical specimens containing a full spectrum of human respiratory viruses. Control material is made available through European Virus Archive – Global (EVAg), a European Union infrastructure project. Conclusion The present study demonstrates the enormous response capacity achieved through coordination of academic and public laboratories in national and European research networks.