Combined TPP for HCV diagnostics following consensus process
A target product profile (TPP) for HCV diagnostics in decentralized settings was finalized in April 2015 through a consensus process that began in 2014 with a series of stakeholder meetings. These were followed by a survey of 50 stakeholder organizations and representatives from 19 countries in early 2015 using a Delphi-like process to facilitate consensus building, which in turn led to a consensus meeting convened by FIND and the Forum for Collaborative HIV Research in Vienna on 22 April 2015. This meeting aimed to build agreement around two TPPs that had been identified by stakeholders to be of high priority for decentralized settings: HCV nucleic acid amplification test (NAAT) for the diagnosis of active HCV infection, and HCV core antigen (cAg) test for the diagnosis of active HCV infection.
Key points arising from the discussion at the consensus meeting in Vienna included:
- HCV diagnostic integration is important in health centres where patients at risk for HCV are evaluated and treated (e.g. drug treatment programmes, STD and HIV clinics). Ideally implementation for screening in the community should be feasible.
- Polyvalent platforms that test for HCV and other diseases, such as HIV, TB or hepatitis B are preferable.
- The minimum and optimal characteristics envisioned by stakeholders were similar for molecular and antigen-based tests.
- TPPs need to be considered in the context of different types of testing algorithms (i.e. a single test versus a two-step process comprising a serology test followed by a confirmatory test).
Different characteristics included in the TPPs were grouped into scope of use, performance and operational characteristics, and price. For each characteristic, participants were presented with a minimal and optimal solution. Following the meeting and as a result of the discussion, a single revised TPP for HCV diagnostics was produced. It is included in this report.