Optimising diagnosis of viraemic hepatitis C infection: the development of a target product profile
| Autor: | Veronica Miller, Teri Roberts, Stefano Ongarello, Alessandra Trianni, Douglas S. Krakower, Nivedha Panneer, Claudia M. Denkinger, Philippa Easterbrook, Elena Ivanova Reipold |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2017 |
| Předmět: |
Pathology
medicine.medical_specialty MEDLINE Consensus criteria Survey result Hepacivirus lcsh:Infectious and parasitic diseases 03 medical and health sciences 0302 clinical medicine Risk Factors Prevalence medicine Humans lcsh:RC109-216 030212 general & internal medicine Intensive care medicine Antigens Viral Poverty High prevalence Diagnostic Tests Routine business.industry Research Product profile Stakeholder Hepatitis C medicine.disease Test (assessment) Infectious Diseases Income RNA Viral 030211 gastroenterology & hepatology business |
| Zdroj: | BMC Infectious Diseases, Vol 17, Iss S1, Pp 159-175 (2017) BMC Infectious Diseases |
| ISSN: | 1471-2334 |
| DOI: | 10.1186/s12879-017-2770-5 |
| Popis: | Background The current low access to virological testing to confirm chronic viraemic HCV infection in low- and middle-income countries (LMIC) is limiting the rollout of hepatitis C (HCV) care. Existing tests are complex, costly and require sophisticated laboratory infrastructure. Diagnostic manufacturers need guidance on the optimal characteristics a virological test needs to have to ensure the greatest impact on HCV diagnosis and treatment in LMIC. Our objective was to develop a target product profile (TPP) for diagnosis of HCV viraemia using a global stakeholder consensus-based approach. Methods Based on the standardised process established to develop consensus-based TPPs, we followed five key steps. (i) Identifying key potential global stakeholders for consultation and input into the TPP development process. (ii) Informal priority-setting exercise with key experts to identify the needs that should be the highest priority for the TPP development; (iii) Defining the key TPP domains (scope, performance and operational characteristics and price). (iv) Delphi-like process with larger group of key stakeholder to facilitate feedback on the key TPP criteria and consensus building based on pre-defined consensus criteria. (v) A final consensus-gathering meeting for discussions around disputed criteria. A complementary values and preferences survey helped to assess trade-offs between different key characteristics. Results The following key attributes for the TPP for a test to confirm HCV viraemic infection were identified: The scope defined is for both HCV detection as well as confirmation of cure. The timeline of development for tests envisioned in the TPP is 5 years. The test should be developed for use by health-care workers or laboratory technicians with limited training in countries with a medium to high prevalence of HCV (1.5–3.5% and >3.5%) and in high-risk populations in low prevalence settings ( |
| Databáze: | OpenAIRE |
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