Target Product Profile for a molecular test for surveillance of cholera

Technical guidance

Target Product Profiles (TPPs) are strategic planning tools for guiding the development of new diagnostic tests and other healthcare products. The primary audiences for TPPs are manufacturers, suppliers and researchers developing new assays. A TPP outlines the key performance and operational characteristics that a product should possess to meet the needs of its intended users, target population and public health programmes, in their intended settings of use. For each characteristic, a TPP states a preferred criterion that is to be achieved by product developers if feasible and a minimal criterion if the preferred criterion is not feasible.

The recently updated surveillance guidance published by the GTFCC recommends that suspected cholera cases be confirmed either by culture or by Polymerase Chain Reaction (PCR). Molecular tests such as PCR are promising tools for cholera surveillance and outbreak confirmation, as they can have high sensitivity and specificity and rapid turnaround times. Molecular tests also enable the detection of epidemic-related features of a strain of V. cholerae, including the genes that encode cholera toxin, an essential virulence factor of epidemic strains. There is a need for easy-for-use, fit-for-purpose, well-performing and validated commercialized molecular test kits for cholera designed for deployment and use in low- and middle-income countries at the level of national laboratories (at least) to support cholera surveillance efforts in endemic countries and guide intervention strategies.

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