WHO's role in SARS-CoV-2 laboratory diagnostics: an end-to-end approach

ABSTRACT

One of the main challenges in an emerging pathogen outbreak is the availability of and access to reliable laboratory diagnostic tests for timely and accurate confirmation of the disease or infection to rapidly inform public health actions. Additional challenges include ensuring that laboratory staff are sufficiently trained and equipped to perform the tests safely, linking public health and clinical data, developing and implementing comprehensive testing strategies and ensuring widely available, affordable in vitro diagnostic tests and supplies. WHO through its regional and country offices serves 194 Member States and, as the leading global health organization, plays a major role in coordinating and assisting countries in their responses to emerging pathogens. WHO's mandate includes establishing and implementing surveillance for emerging and re-emerging pathogens and noncommunicable diseases, develop ment of normative guidance and regulatory frameworks, providing technical assistance to countries, supporting country capacity through training and simulation exercises, establishing research agendas and leading implementation research to inform guid ance development and public health action. Platforms, systems and partnerships have been established to ensure early detection of novel viruses, including syndromic surveillance, rapid molecular testing and genetic sequencing, and facilitating the development of vaccines and benefit-sharing. We describe the work of WHO and partners on SARS-CoV-2 in vitro diagnostics and highlight considerations for moving forward. Within days of learning of the cluster of cases of pneumonia of unknown etiology in Wuhan, China,7 WHO brought together coronavirus laboratory experts who were already members of WHO's informal MERS-CoV laboratory network and the Global Laboratories Alliance for the Diagnosis of High Threat Pathogens to develop and publish interim guidance for laboratories within 2 weeks of first suspected cases being reported. As more diagnostic tests were developed and manufactured by suppliers, WHO worked with experts in the SARS-CoV-2 reference laboratory network and partners, including the Foundation for Innovative New Diagnostics, to review their performance and diagnostic accuracy. Target product profiles for diagnostic tests were developed to notify suppliers, manufacturers and countries of the necessary characteristics for diagnostics on the market. The Strategic Advisory Group of Experts on IVD added NAAT and antigen-detection RDTs for SARS-CoV-2 to the 3rd edition of the WHO Model list of Essential In Vitro Diagnostics, which is used by countries as a reference to develop or update their lists of IVD tests for universal health coverage and outbreak response.