Improved Molecular Diagnosis of COVID-19 by the Novel, Highly Sensitive and Specific COVID-19-RdRp/Hel Real-Time Reverse Transcription-PCR Assay Validated <i>In Vitro</i> and with Clinical Specimens
Jasper Fuk‐Woo Chan, Cyril Chik‐Yan Yip, Kelvin Kai‐Wang To, Tommy Hing‐Cheung Tang, Sally C. Y. Wong, Kit‐Hang Leung, Agnes Yim-Fong Fung, Anthony Chin‐Ki Ng, Zijiao Zou, Hoi‐Wah Tsoi, Garnet Kwan-Yue Choi, Anthony Raymond Tam, Vincent Chi‐Chung Cheng, Kwok‐Hung Chan, Owen Tak‐Yin Tsang, Kwok‐Yung Yuen
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.