| Popis: |
Background Diagnostic tests play a crucial role during an epidemic or a pandemic, both for individual patient care, and as a tool in population-level non-pharmaceutical interventions. The development and evaluation of such tests during epidemics faces numerous challenges, including short timeframes, and changing disease prevalence, pathogen characteristics, and testing applications. In this position paper, we describe these challenges through an interdisciplinary lens and present potential solutions, based on experiences during the SARS-CoV-2 pandemic. Methods We conducted a workshop that brought together experts from various disciplines involved in diagnostic test development and evaluation, from molecular test development to public health decision-making. The challenges and potential solutions we discuss are derived from discussions had and conclusions drawn in the workshop. Results We identified a feedback loop between evaluation of test accuracy, integration of test accuracy estimates in modelling studies for public health decision-making, and population-level interventions that determine testing strategies, and can define how diagnostic tests might need re-evaluation. Incorporating this feedback loop into test evaluation can help diagnostic test development be optimised for both individual patient care and population level measures. Furthermore, adaptive and seamless designs for diagnostic studies provide a promising methodological solution to narrow timeframes and the need for continuous re-evaluation of diagnostic tests during epidemic or pandemic situations. Conclusions We present a framework for diagnostic test development and evaluation that acknowledges the feedback loop between diagnostic test studies and infectious disease modelling studies, and provides solutions to challenges faced in test development and evaluation during outbreaks of emerging infectious agents. |
