Table 3. Acceptable and desired target product profile characteristics focused on operational characteristics, as defined by an expert consensus process 2015–16.
| Characteristic | Acceptable ("must have") | Desired ("would like") | Reference | |
|---|---|---|---|---|
| Multiplexing | ≥1 analyte | ≥1 analyte plus pathogen specific testing (priority: malaria) | Expert consensus | |
| Ease of test performance | ≤2 timed steps during assay performance | No timed step during the assay performance | Expert consensus | |
| Sample type | Capillary blood or urine | Capillary blood or any less invasive sample than blood, like: Saliva | Expert consensus | |
| Volume | - Capillary blood: - patients > 6 years[41] - 100μL (~ 4 drops); - pediatric patients 2–6 years[41]– 50–100μL (~2 drops); - Saliva: < 0.5mL - Urine: ~1mL of urine |
- Capillary blood: 25μL (~1 drop) for all age groups - Saliva: <0.5mL for saliva |
Expert consensus | |
| Sample collection | Transfer and quantification device included in the test | Industry standard | ||
| Additional sample preparation | 1 sample-processing steps | None required | Expert consensus | |
| Kit configuration | No additional reagents outside of the kit required (including gloves) | Industry standard | ||
| Process control | Internal control to provide test validity and acceptance | Expert consensus | ||
| Batch/Quality control | Positive and negative controls required to monitor the quality of kit | Expert consensus | ||
| Reagent preparation | - Minimal of one additional step to prepare prior to use - No (precise) measuring required. |
No additional reagents required, everything is provided ready-to-use | [32] | |
| Time to result (per sample) | <2 hours | <10min | Expert consensus, Ivanova et. al. in preparation | |
| Hands on time | Total hands-on-time should be <5 min | Total hands on time should be <1 min | Expert consensus | |
| Sample throughput | Ability to test individual samples or multiple samples if needed (no need for batching) | Expert consensus | ||
| Result stability | ≥15 min | ≥1 hour | Industry standard | |
| Assay type | Qualitative | Quantitative | Expert consensus | |
| Biosafety | No need for a biosafety cabinet; basic safety procedures need to be followed | [42] | ||
| Waste disposal | Biohazard waste | - Testing device - Compostable plastics for minimal environmental impact |
[42] | |
| Storage conditions and Self-life | - 12 month at fluctuating temperature (0–40°C) - ≤90% relative humidity - No controlled temperature required |
- 24 month at fluctuating temperature (0–50°C) - ≤90% relative humidity - No controlled temperature required |
Expert consensus | |
| Operation conditions | - Between 5°C—40°C - ≤90% humidity |
- Between 5°C—45°C - ≤90% humidity |
Expert consensus | |
| Shipping conditions | Shipping without cold chain; should tolerate stress during transport (≤72h at +50°C) | Expert consensus | ||
| Training requirementsa | <2 days including proficiency panel | <0.5 day including proficiency panel | [32] | |
| Equipment (instrument external to test) | Small, robust, dust-resistant, portable or hand-held integrated instrument that must operate on battery | Reusable instrumentation not required | Expert consensus | |
| Power supply | Battery or solar powered | None required | [32] | |
| Water supply | No external water required | Industry standard | ||
| External maintenance | - Preventative maintenance at 2 year or >4000 samples; simple with only minimal expertise - Maintenance alert should be included. |
None required | Industry standard | |
| Calibration | Remote calibration or auto-calibration | No calibration required | Industry standard | |
| Data output | Qualitative | Non-ambiguous results displayed (e.g. bacterial/non-bacterial–yes or no) | Expert consensus | |
| Data interpretationb | Minimal interpretation required | No interpretation required | Expert consensus | |
| Connectivity | Not required | Wireless connectivity | Isaak et. al. in preparation | |
| Reproducibility | >95% standard deviation between repeats | [43] | ||
a Training to use the test, not including clinical/treatment implications and consequences.
b Interpretation of the test result, not the clinical/treatment conseque