Framework for the evaluation of new tests for tuberculosis infection
29 July 2020 | GENEVA - The World Health Organization (WHO) and the Stop TB Partnership’s New Diagnostics Working Group (NDWG) launched today a framework for the evaluation of new tests for tuberculosis infection. The document provides details on study design, populations, reference standards, sample size calculation and data analysis to guide the future development of these tests.
Approximately a quarter of the world’s population is estimated to be infected with Mycobacterium tuberculosis. Treatment of TB infection, also known as tuberculosis preventive treatment (TPT), aims to prevent the development of TB disease, and is one of the critical components to achieve the ambitious targets of the WHO End TB Strategy. At the United Nations High-level Meeting (UNHLM) on TB in 2018, countries committed to provide TPT to at least 30 million people in 2018-2022.
“We urgently need new tests for TB infection to expand
access to TB preventive treatment for the millions in need, to
stop the onset of disease, avert suffering and save lives," said
Dr Tereza Kasaeva, Director, WHO Global TB Programme. “New
tests with better operational characteristics which can be
easily scaled up in the community are vital to overcome the
current challenges of fragile supply lines, high cost,
cold-chain requirements, uncertainty about quality-assurance,
and appropriate laboratory infrastructure.”
This framework for evaluation of new tests for the detection of
TB infection has been produced to direct research and to
facilitate a standardized evaluation, thus accelerating the
adoption of the tests into global and national policy and
subsequent scale-up. The document covers technical issues that
should be considered when evaluating new tests for TB infection,
such as evaluation of the safety of skin tests, costs to the
health system and its users, preferred features and operational
characteristics. It is intended for manufacturers of
diagnostics, researchers, research funders, regulators, TB
programme coordinators, civil society and other stakeholders.
“We will not be able to progress towards ending TB without
reliable tests to confirm TB infection” said Dr Alberto
Matteelli, University of Brescia, Italy and coordinator of the
Task Force that prepared the framework document. “Although
currently testing for TB infection is not always required before
starting TPT, a positive test result will help direct TPT to
those would benefit most from treatment and avoid unnecessary
medication”.
Source:
WHO
