Improved Molecular Diagnosis of COVID-19 by the Novel, Highly Sensitive and Specific COVID-19-RdRp/Hel Real-Time Reverse Transcription-PCR Assay Validated In Vitro and with Clinical Specimens

Author:

Chan Jasper Fuk-Woo12345,Yip Cyril Chik-Yan6,To Kelvin Kai-Wang1234ORCID,Tang Tommy Hing-Cheung7,Wong Sally Cheuk-Ying8,Leung Kit-Hang3,Fung Agnes Yim-Fong3,Ng Anthony Chin-Ki3,Zou Zijiao3,Tsoi Hoi-Wah3,Choi Garnet Kwan-Yue6,Tam Anthony Raymond9,Cheng Vincent Chi-Chung6,Chan Kwok-Hung134,Tsang Owen Tak-Yin10,Yuen Kwok-Yung2345

Affiliation:

1. State Key Laboratory of Emerging Infectious Diseases, The University of Hong Kong, Pokfulam, Hong Kong Special Administrative Region, China

2. Department of Clinical Microbiology and Infection, The University of Hong Kong-Shenzhen Hospital, Shenzhen, Guangdong Province, China

3. Department of Microbiology, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Pokfulam, Hong Kong Special Administrative Region, China

4. Carol Yu Centre for Infection, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Pokfulam, Hong Kong Special Administrative Region, China

5. Hainan Medical University-The University of Hong Kong Joint Laboratory of Tropical Infectious Diseases, Hainan Medical University, Haikou, Hainan, and The University of Hong Kong, Pokfulam, Hong Kong Special Administrative Region, China

6. Department of Microbiology, Queen Mary Hospital, Pokfulam, Hong Kong Special Administrative Region, China

7. Department of Medicine, Queen Elizabeth Hospital, Hong Kong, Hong Kong Special Administrative Region, China

8. Department of Pathology, Queen Elizabeth Hospital, Hong Kong, Hong Kong Special Administrative Region, China

9. Department of Medicine, Queen Mary Hospital, Pokfulam, Hong Kong Special Administrative Region, China

10. Department of Medicine and Geriatrics, Princess Margaret Hospital, Hong Kong, Hong Kong Special Administrative Region, China

Abstract

On 31 December 2019, the World Health Organization was informed of a cluster of cases of pneumonia of unknown etiology in Wuhan, China. Subsequent investigations identified a novel coronavirus, now named severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), from the affected patients. Highly sensitive and specific laboratory diagnostics are important for controlling the rapidly evolving SARS-CoV-2-associated coronavirus disease 2019 (COVID-19) epidemic. In this study, we developed and compared the performance of three novel real-time reverse transcription-PCR (RT-PCR) assays targeting the RNA-dependent RNA polymerase (RdRp)/helicase (Hel), spike (S), and nucleocapsid (N) genes of SARS-CoV-2 with that of the reported RdRp-P2 assay, which is used in >30 European laboratories.

Funder

Michael Seak-Kan Tong

Respiratory Viral Research Foundation Limited

Marina Man-Wai Lee

Theme-Based Research Scheme of the Research Grants Council, HKSARS

The Hong Kong Hainan Commercial Association South China Microbiology Research Fund

High Level-Hospital Program, Health Commission of Guangdong Province, China

Richard Yu and Carol Yu

Hui Ming

Hui Hoy and Chow Sin Lan Charity Fund Limited

Chan Yin Chuen Memorial Charitable Foundation

Publisher

American Society for Microbiology

Subject

Microbiology (medical)

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