Table 1. Target product profile characteristics and their priority, expert consensus process 2015–16.

Priority for discussion	Characteristics
High	Target population, Level of health system, Analytical sensitivity/Limit of Detection (LOD), Diagnostic sensitivity/specificity, Target price, Time-to-result, Hands-on-time, Training requirements
Medium	Multiplexing, Ease of test performance, Sample type, Additional sample preparation, Throughput, Result stability, Shipping conditions, Equipment, Calibration, Connectivity, Reproducibility
Low	Target user, Volume, Reagent preparation, Waste disposal, Power supply, External maintenance, Data interpretation
Very low	Sample collection, Kit configuration, Control material, Analysis type, Biosafety, Storage conditions, Operation conditions, Water supply

A total of 35 test characteristics were included in the TPP, as shown in the list below. The following definitions were used for ranking. High: Large divergence between expert opinions, and/or significant implications for the final assay, and/or limited published evidence to guide decision. Medium: Some divergence between expert opinions, and/or Limited published evidence to guide decision, and/or review of wording after changes, and/or common characteristics modified after initial review. Low: Some divergence between expert opinions, and/or limited implications for the final assay, and/or strong published evidence available to guide decision. Very low: No divergence between expert opinion, and/or FDA/industry consensus already available.