T Adepoyibi1, L Lilis2, H Greb2, D Boyle2. 1. PATH, Seattle, Washington, USA;, Burnet Institute, Melbourne, Victoria, Australia. 2. PATH, Seattle, Washington, USA.
Abstract
SETTING: New diagnostic tools for tuberculosis (TB) are urgently needed. To guide investment decisions, sufficient information regarding which test attributes are the most important for users and decision makers interested in introducing TB diagnostics should be made available. OBJECTIVE: To rank test attributes in a target product profile (TPP) in order of importance for a sputum smear replacement test for TB. DESIGN: An online survey was administered among 33 participants representing 14 of the 22 TB high-burden countries. Respondents included laboratory personnel, national TB program managers, donors, technical experts, patients and researchers. Participants were asked to rank 21 TPP test attributes in order of importance using a maximum-differential method that required ranking of relative trade-offs. RESULTS: Sensitivity was ranked as the most important test attribute, followed by maintenance/calibration, reagent kit storage/stability, sample preparation steps and time to results. CONCLUSION: Consulting widely regarding which TPP attributes are valued most by users and decision-makers involved in introducing TB diagnostics can assist TB test developers to prioritize their investments, and guide decision making if trade-offs are necessary.
SETTING: New diagnostic tools for tuberculosis (TB) are urgently needed. To guide investment decisions, sufficient information regarding which test attributes are the most important for users and decision makers interested in introducing TB diagnostics should be made available. OBJECTIVE: To rank test attributes in a target product profile (TPP) in order of importance for a sputum smear replacement test for TB. DESIGN: An online survey was administered among 33 participants representing 14 of the 22 TB high-burden countries. Respondents included laboratory personnel, national TB program managers, donors, technical experts, patients and researchers. Participants were asked to rank 21 TPP test attributes in order of importance using a maximum-differential method that required ranking of relative trade-offs. RESULTS: Sensitivity was ranked as the most important test attribute, followed by maintenance/calibration, reagent kit storage/stability, sample preparation steps and time to results. CONCLUSION: Consulting widely regarding which TPP attributes are valued most by users and decision-makers involved in introducing TB diagnostics can assist TB test developers to prioritize their investments, and guide decision making if trade-offs are necessary.
Authors: Samuel G Schumacher; William A Wells; Mark P Nicol; Karen R Steingart; Grant Theron; Susan E Dorman; Madhukar Pai; Gavin Churchyard; Lesley Scott; Wendy Stevens; Pamela Nabeta; David Alland; Karin Weyer; Claudia M Denkinger; Christopher Gilpin Journal: J Infect Dis Date: 2019-10-08 Impact factor: 5.226