Lessons Learned: Defining the Right Specifications for Diagnostics in Outbreak Situations.

Introduction: The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic significantly changed the development and use of infectious disease diagnostics, emphasizing the need for rapid implementation, access equity, and revealing challenges in evaluation and licensing from unclear guidelines.

Methods: An international expert panel was convened by Roche Diagnostics, Fraunhofer Institute for Translational Medicine and Pharmacology (Immunology, Infection and Pandemic Research division), and Ludwig Maximilians University to address these challenges. The panel aimed to develop parameters for designing minimal viable products and consequence-centered diagnostic strategies, focusing on the broader implications of test results for public health interventions and disease control rather than individual test performance.

Results: Key findings included the need to tailor target product profiles to outbreak scenarios, considering socioeconomic factors and outbreak phases. Prioritizing rapid, cost-effective, and widely accessible tests, even at the expense of lower sensitivity was highlighted. Using such tools was effective during the SARS-CoV-2 pandemic because they were wider-reaching and identified more cases, especially in low-/middle-income countries where highly sensitive molecular tests had limited availability.

Conclusion: Modeling different testing strategies allows outbreak control programs to quantify the impact of trade-offs between accessibility, affordability, and speed of diagnosis in different outbreak settings.