Durski, Kara N, Vojnov, Lara, Cognat, Sebastian, Carter, Lisa, Cunningham, Jane, Moussy, Francis, Prat, Irena, Stroher, Ute, Nahapetyan, Karen, Mendez-Rico, Jairo, Zwetyenga, Joanna, von Eije, Karin J, Perkins, Mark, Ali Ahmed, Yahaya, Konings, Frank, Inbanathan, Francis Yesurajan, Subissi, Lorenzo, Barakat, Amal, Herring, Belinda, Ryan, Michael, Balkhy, Hanan, van Kerkhove, Maria D, and Laboratory Diagnostics Team, COVID-19
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. Despite the many challenges of the pandemic, tools for laboratory diagnosis of SARS-CoV-2 infection were developed and implemented at an astonishingly fast pace through global partnerships, engagement of private industry, financing and collaboration. 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.1–4 WHO’s mandate includes establishing and implementing surveillance for emerging and re-emerging pathogens and noncommunicable diseases, development of normative guidance and regulatory frame-works, providing technical assistance to countries, supporting country capacity through training and simulation exercises, establishing research agendas and leading implementation research to inform guidance development and public health action. A functional, integrated surveillance system and a national laboratory system are priorities for a strong national epidemic or pandemic response. WHO has been working for decades on strengthening country and regional laboratory capacity to detect and respond to known and new pathogens, including novel respiratory viruses. 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. These systems have been strengthened over decades, from syndromic surveillance of influenza to addressing emerging challenges such as SARS-CoV, influenza A(H5N1), MERS-CoV, Nipah virus and disease X. The Global Influenza Surveillance and Response system (GISRS) is an example of an effective global laboratory network (150 laboratories in 126 countries) that monitors circulating influenza viruses to inform the composition of annual influenza vaccines and also has the capacity to detect and issue alerts about emerging influenza viruses with pandemic potential. Over 1 year into the COVID-19 pandemic, ensuring strong and strategic testing for SARS-CoV-2 linked to rapid public health actions remains a priority for all countries. The pandemic is profoundly complex, including its impact on health systems, the economy and wellbeing, and therefore requires a holistic, “allof-society” approach. Strategic and tactical planning for diagnostic testing, from development of tests to use in health facilities, is critical. We describe the work of WHO and partners on SARS-CoV-2 in vitro diagnostics. (IVD) and highlight considerations for moving forward.