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Updated: Mar 28, 2026

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

Markus Beutler1, Pablo Bonvehí2, May Chu3

  • 1Roche Diagnostics GmbH, Nonnenwald 2, 82377, Penzberg, Germany. markus.beutler@roche.com.

Infectious Diseases and Therapy
|March 26, 2026
PubMed
Summary
This summary is machine-generated.

Developing rapid, accessible diagnostic tests for infectious diseases like SARS-CoV-2 is crucial. Strategies balancing speed, cost, and accessibility are vital for effective public health interventions, especially in resource-limited settings.

Keywords:
DiagnosisEquitable accessMinimum viable productModellingPandemicPandemic preparednessTarget product profileTesting strategiesViral outbreak

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Area of Science:

  • Infectious disease diagnostics
  • Public health preparedness
  • Pandemic response

Background:

  • The SARS-CoV-2 pandemic highlighted critical needs in infectious disease diagnostics, including rapid deployment, equitable access, and clear regulatory pathways.
  • Existing evaluation and licensing guidelines presented challenges during the pandemic.

Purpose of the Study:

  • To develop parameters for minimal viable products and consequence-centered diagnostic strategies.
  • To focus on the public health implications of diagnostic test results rather than solely individual test performance.

Main Methods:

  • An international expert panel convened by Roche Diagnostics, Fraunhofer Institute, and Ludwig Maximilians University addressed diagnostic challenges.
  • The panel focused on developing strategies for outbreak scenarios, considering socioeconomic factors and disease phases.

Main Results:

  • Tailoring diagnostic target product profiles to specific outbreak scenarios is essential.
  • Prioritizing rapid, cost-effective, and accessible tests, even with lower sensitivity, proved effective during the SARS-CoV-2 pandemic.
  • Widely accessible tests identified more cases, particularly in low- and middle-income countries with limited access to sensitive molecular tests.

Conclusions:

  • Modeling diagnostic testing strategies allows for quantification of trade-offs between accessibility, affordability, and speed.
  • These insights aid outbreak control programs in optimizing diagnostic approaches for diverse settings.