Laboratory Guidelines for Detection and Diagnosis of the Novel Coronavirus (2019-nCoV) Infection

Abstract

Coronaviruses are a group of highly diverse RNA virus in the Coronaviridae family that are divided in 4 genera: alpha, beta, gamma and delta that cause disease varying from mild to severe in human and animals. There are endemic human coronavirus as the alphacoronavirus 229E and NL63 and betacoronaviruses OC43 and HKU1 that can cause influenza-like illness or pneumonia in humans. However, two zoonotic coronavirus have emerged causing severe disease in humans: severe acute respiratory syndrome coronavirus (SARS-CoV) in 2002-2003 and Middle East respiratory syndrome coronavirus (MERS-CoV). In January 2020, the etiologic agent responsible for a cluster of severe pneumonia cases in Wuhan, China was identified as being a novel Betacoronavirus, but it is distinct from SARS-CoV and MERS-CoV. The complete genome sequence of this new agent has been released and different detection protocols have been developed but not fully validated yet. However, in light of the possible introduction of a suspected case related to 2019-nCoV in the America region, the Pan American Health Organization / World Health Organization (PAHO/WHO) recommends to Member States to ensure their timely identification, the shipping of samples to National and reference laboratories and the implementation of the molecular detection protocol for 2019-nCoV, according to the laboratory capacity. WHO have published on 17 January 2020 an updated of the interim guidance for Laboratory testing for 2019 novel coronavirus (2019-nCoV) in suspected human cases available at: https://www.who.int/healthtopics/coronavirus/laboratory-diagnostics-for-novel-coronavirus. Information on Suspected case definition; specimen collection and shipment; effective usage of global laboratory networking; testing of 2019-nCoV in reference laboratories; and reporting of cases and test results can be found in this interim guidance.