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Target product profiles for tests for tuberculosis treatment monitoring and optimisation.

S Den Boon(1)

1:World Health Organization

Discovery, development and rapid uptake of new tools are critical to substantially reduce TB incidence and reach the global End TB targets. To aid the development of new tests and tools, WHO is developing new target product profiles (TPPs) for tests for TB treatment monitoring and optimisation. These TPPs cover desired tests for three different use case scenarios 1) tests that are done at treatment initiation to identify patients who should be treated with a different or shorter TB regimen; 2) tests that are done during treatment to identify patients with a poor response to treatment who might benefit from a different or longer (optimised) TB treatment regimen, adherence support interventions or adjunctive therapies, or undergo further testing (e.g. for drug resistance); and 3) tests done at the presumed end of treatment to identify patients who should stop TB treatment (“test of cure”). The TPPs identify minimum and optimal targets for the following characteristics (some of which are common to the three use cases and some of which are unique): assay/instrument design, sample throughput (for instrument-based assays), operational environment, environmental impact, maintenance (for instrument-based assays) and quality control, target setting, target user, training and education, turnaround time, results, cost of test (including cost of reagents and consumables), cost of instrument, target population, sample type (if a clinical sample is required), sensitivity, specificity, timing, and frequency. These TPPs are expected to serve as an important tool to set research and development targets for funders and developers.

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