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Framework for the evaluation of new tests for tuberculosis infection
Yohhei Hamada1,2, Saskia den Boon3, Daniela Maria Cirillo4
1Research Institute of Tuberculosis, Japan Anti-Tuberculosis Association, Tokyo, Japan y.hamada@ucl.ac.uk.
The European Respiratory Journal
|January 22, 2021
Summary
Accelerating tuberculosis (TB) preventive treatment (TPT) requires simpler TB infection tests. This framework guides the evaluation of new immunodiagnostic tests to speed up adoption and scale-up.
Area of Science:
- Immunology
- Public Health
- Infectious Diseases
Background:
- Global targets necessitate accelerated scale-up of tuberculosis (TB) preventive treatment (TPT).
- Current TB infection testing methods face operational challenges hindering TPT scale-up.
- Development of simpler diagnostic tests is crucial for widespread TB infection screening.
Purpose of the Study:
- To present a standardized framework for evaluating novel immunodiagnostic tests for TB infection.
- To facilitate the adoption of new TB infection tests into global and national health policies.
- To guide manufacturers, researchers, and regulators in test evaluation and scale-up.
Main Methods:
- Development of a comprehensive evaluation framework for new TB infection tests.
- Guidance on study design, population selection, reference standards, and sample size calculation.
- Consideration of technical aspects including safety, cost, and operational characteristics.
Main Results:
- A structured approach for evaluating new TB infection immunodiagnostic tests is proposed.
- The framework addresses key principles for standardized assessment.
- Guidance is provided for various stakeholders involved in TB diagnostics.
Conclusions:
- A standardized evaluation framework is essential to accelerate the adoption and scale-up of new TB infection tests.
- Addressing operational and technical challenges is key to improving TPT delivery.
- This framework supports the global strategy for TB research and innovation.
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