The WHO has developed target product profile (TPPs) describing the most appropriate qualities for TB diagnostics and treatments to align their features with the requirements of therapeutic and eradication programmes.
Target product profile for TB
For TB the WHO TPP has the following requirements:
Ease of use – diagnostic must be easy to integrate within existing testing regimes – the sample needs to be accessible with minimal training and to demonstrate the presence of incipient TB.
Cost-effective for rapid screening – diagnostic needs to suitable for rapid screening of asymptomatic patients and perform reliably within given parameters.
Operationally stable – the analysis must be easy to transfer from one lab to another, to have a short number of steps, require minimal training to achieve a result, reagents to be stable within defined temperatures.
To gain a lab side evaluation, Actiphage is currently in trials by the Rapid Research in Diagnostics Development for TB Network (R2D2 TB Network), which is funded by the US National Institutes of Health, at a clinical site in the Philippines. This will give an independent assessment of its usability and fit with the target product profile.
More information about WHO TPP