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A Tuberculosis Molecular Bacterial Load Assay (TB-MBLA)

A Tuberculosis Molecular Bacterial Load Assay (TB-MBLA)

Published on: April 30, 2020

Beyond accuracy: creating a comprehensive evidence base for TB diagnostic tools.

G Mann¹, S B Squire, K Bissell

¹Liverpool School of Tropical Medicine, Liverpool, UK. ghmann@liv.ac.uk

The International Journal of Tuberculosis and Lung Disease : the Official Journal of the International Union Against Tuberculosis and Lung Disease

|December 15, 2010

Summary

A new Impact Assessment Framework (IAF) systematically compiles evidence on diagnostic tool effectiveness, equity, health systems, scale-up, and policy. This framework aids decision-making for implementing new tuberculosis diagnostic tools.

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Area of Science:

Public Health
Health Services Research
Medical Diagnostics

Background:

Stakeholders, including the New Diagnostics Working Group (NDWG) and Stop TB Partnership, emphasize the need for robust evidence to guide the implementation of new diagnostic tools.
Existing approaches often lack a systematic method for collecting policy-relevant data throughout the development lifecycle of diagnostic tools.

Purpose of the Study:

To introduce and describe the Impact Assessment Framework (IAF), a systematic approach for evaluating new diagnostic tools.
To outline the IAF's structure and its utility for developers and policymakers in assessing diagnostic tool implementation.

Main Methods:

Development of a multi-layered Impact Assessment Framework (IAF) linking evidence on inputs to outcomes.
The IAF integrates five key analytical layers: effectiveness, equity, health systems, scale-up, and policy analysis.
The framework is designed for use during the demonstration phase and beyond, collecting data relevant to policy decisions.

Main Results:

The IAF provides a structured method for collecting comprehensive, policy-relevant data on new diagnostic tools.
It facilitates the assessment of diagnostic tools across multiple dimensions crucial for adoption and scale-up.
The framework has been adopted by the TREAT TB initiative and incorporated into key tuberculosis diagnostic development publications.

Conclusions:

The Impact Assessment Framework (IAF) offers a systematic approach to generate evidence for informed decision-making regarding new diagnostic tools.
Continued refinement and implementation of the IAF are crucial for overcoming challenges in evaluating and scaling up diagnostic innovations.
The IAF supports international and national policymakers in making evidence-based decisions for the adoption and implementation of improved tuberculosis diagnostics.