The Forum for Collaborative HIV Research and the Foundation for Innovative New Diagnostics (FIND) have released a report of a consensus meeting on target product profiles for high-priority hepatitis C diagnosis in decentralized settings.
The meeting, convened by FIND and the Forum for Collaborative HIV Research, was held in Vienna, Austria on April 22, 2015 to build consensus around two target product profiles for hepatitis C diagnostics that were identified by stakeholders to be of high priority for the diagnosis of active HCV infection in decentralized settings: an HCV nucleic acid amplification test (NAAT) and an HCV core antigen (cAg) test.
Fifty stakeholder organizations and individuals from 19 countries were surveyed before the meeting through a Delphi-like process to facilitate consensus building around the TPPs. Different characteristics included in the TPPs were grouped into scope of use, performance and operational characteristics, and price. Further discussions at the meeting built consensus on the majority of characteristics. The minimum and optimal characteristics envisioned by stakeholders were similar for molecular and antigen-based tests. Following the meeting and as a result of the discussion, a single revised TPP for HCV diagnostics was produced and is included in this report.
