Target product profile for a rapid diagnostic test for surveillance of cholera outbreaks

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.

Since 2017, GTFCC has focused on encouraging the availability and use of RDTs, developing the TPP for cholera RDTs first published in 2017 and related WHO prequalification standards. However, since 2017, GTFCC has agreed to modify some of the previously agreed upon minimal characteristics that were deemed too stringent, thus there was a need to update the TPP accordingly. The TPP for a cholera RDT described in this document is informed by the previously developed TPP, but here were incorporate advances in the field and the most recently updated GTFCC guidelines.

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