Laboratory Guidelines for the Detection and Diagnosis of COVID-19 Virus Infection, 30 March 2020

ABSTRACT

Coronaviruses are a group of highly diverse RNA viruses 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 (1-3). There are endemic human coronavirus as alphacoronaviruses 229E and NL63 and betacoronaviruses OC43 and HKU1 that can cause influenza-like illness or pneumonia in humans. However, two zoonotic coronaviruses 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, distinct from SARS-CoV and MERS-CoV. On 11 February 2020, the International Committee on Taxonomy of Viruses (ICTV) announced that the virus was named severe acute respiratory syndrome coronavirus (SARS-CoV-2) while, on the same day, WHO named the disease as coronavirus disease COVID-19. For communication purposes we will refer the virus as “the virus responsible for COVID-19” or “the COVID-19 virus”. Complete genomic sequences of the COVID-19 virus have been released and different molecular detection protocols developed but not fully validated yet. However, given the current circulation of COVID-19 in the Americas region, the Pan American Health Organization/World Health Organization (PAHO/WHO) recommends to Member States to ensure timely identification of suspect cases, collection and shipping of samples to reference laboratories, and implementation of molecular detection protocols, according to the laboratory capacity. On 19 March 2020, WHO updated its interim guidance on the Laboratory testing for coronavirus disease (COVID-19) in suspected human cases which includes information on specimen collection and shipment, laboratory testing, and reporting of cases and test results. WHO also updates COVID-19 suspect case definitions as needed...