Target Product Profiles for TB diagnosis and detection of drug resistance
WHO releases updated Target Product Profiles for TB diagnosis and detection of drug resistance.
14 August 2024 | Geneva --The World Health Organization (WHO) has published today updated Target Product Profiles (TPPs) for tuberculosis diagnosis and detection of drug resistance. These TPPs define the most important characteristics and requirements to be considered in the development of new TB diagnostics.
The document consolidates two TPPs for TB diagnostics to be carried out at the peripheral level: a newly updated TPP for a rapid test for TB detection and a TPP released in 2021 on next-generation drug susceptibility testing for M. tuberculosis. The updated and consolidated TPPs introduces, for the first time, definitions of classes of point-of-care (POC) tests and near-POC tests, and it relates these to the class of low-complexity diagnostic technologies currently recommended by WHO. The rapid diagnostic TPP does not distinguish between sputum-based and non-sputum-based tests, meaning that either option would be suitable as long as the diagnostic tool meets the required target. A model-based approach was used to inform discussions on the new tests' performance and cost per test.
“The diagnostic options for people with TB, including with drug-resistant TB, are increasing thanks to the manufacturers’ engagement and novel research, generating new evidence. Ensuring that everyone in need can obtain a rapid and accurate diagnosis is crucial to prevent and finally eliminate TB,” said Dr Tereza Kasaeva, Director of WHO’s Global TB Programme.
Target Product Profiles for TB diagnosis and detection of drug resistance
Source: WHO