Ending the pandemic involves the accurate application of diagnostic testing in high volumes and the rapid use of the results to help implement the appropriate therapy and prevent further spread. The ongoing COVID-19 pandemic has underpinned the central position of diagnostic testing in outbreak control 4. The use case determines the way in which diagnostic tests are used optimally 3. These include triage of symptomatic individuals in an epidemic or endemic setting, triage of at-risk presymptomatic and symptomatic individuals in endemic settings, confirmatory testing, diagnosis of symptomatic individuals in endemic or epidemic settings, differential diagnosis in endemic or epidemic settings, testing of patients with previous exposure to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2 the cause of the coronavirus disease 2019 (COVID-19) pandemic), surveillance at sites of previous or potential outbreaks and environmental monitoring ( Foundation for Innovative New Diagnostics (FIND)). Here we will mostly focus on the nucleic amplification tests, with illustrations of how immune tests may complement molecular tests in several cases.ĭiagnostics can be used in various manners, the so-called use cases. This is most frequently focused on the detection of virus-specific antibodies, whereas some specialized laboratories may also be capable of defining the cellular immune response. Immunological tests detect the consequences of infection by the virus in the host. The latter are what are currently called ‘molecular tests’. This can be done by culture of the virus, detection of one or more of its proteins and, the method used most frequently during the present pandemic, direct detection of nucleic acids or detection via amplification of nucleic acids. First there is the direct detection of (parts of) the virus. ![]() The current diagnostic procedures are twofold. ![]() Being able to define the pathogen, biologically and genetically, and whether it is inducing (protective) immunity are key in the development of protective and curative protocols against future persisting disease. ![]() The detection and characterization of the etiological agent or its immunological consequences in the host are the necessary starting points 2. Continuous global improvement in diagnostic test preparedness is essential for more rapid detection of patients, possibly at the point of care, and for optimized prevention and treatment, in both industrialized countries and low-resource settings.ĭuring a pandemic there are multiple concurrent clinical priorities, including the need to understand the pathophysiology of the disease, optimized patient care and prevention of future infections 1. We explore the technical and implementation problems encountered during this early phase in the pandemic, and try to define future directions for the progressive and better use of (syndromic) diagnostics during a possible resurgence of COVID-19 in future global waves or regional outbreaks. In this Review, we summarize the crucial role of diagnostic tests during the first global wave of COVID-19. Hundreds of molecular tests and immunoassays were rapidly developed, albeit many still await clinical validation and formal approval. ![]() During the early phase of the coronavirus disease 2019 (COVID-19) pandemic, design, development, validation, verification and implementation of diagnostic tests were actively addressed by a large number of diagnostic test manufacturers.
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