WHO/BS.2020.2402 Collaborative Study for the Establishment of a WHO International Standard for SARS-CoV-2 RNA

Overview

In support of the global response to the 2019 emergence of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), and subsequent pandemic in 2020, the World Health Organization (WHO) has highlighted the importance of the availability of an International Standard (IS) for SARS-CoV-2 RNA. The intended use of the IS is for the calibration and control of nucleic acid amplification techniques (NAT), which are considered the gold standard method for accurate diagnosis of infection. This report describes the results of a multi-centre collaborative study to evaluate two candidate materials for their ability to harmonise the potencies of a panel of SARS-CoV-2 RNA samples between different laboratories. The candidates included an inactivated virus isolate (Candidate 1; NIBSC code 20/146) and a synthetic SARS-CoV-2 RNA preparation (Candidate 2; 20/138). Seventeen laboratories returned 32 datasets from 21 methods, covering in-house and commercial assays based on digital PCR, real-time PCR and Transcription Mediated Amplification technology.