Table 2.
Target product profile for test procedure and additional characteristics of a gene drive rapid diagnostic test
| Feature | Minimally essential | Ideal | Considerations |
|---|---|---|---|
| Reagent reconstitution | All reagents supplied, with minimal reconstitution | All reagents are immediately ready to use | Access to pure water or other reagents cannot be relied upon |
| Time to result from test initiation | < 120 min | < 30 min | Tests are intended to be used on brief visits to field sites |
| Result validity stability | Up to 30 min | Up to 24 h | Flexibility in readout times will enable parallel workstreams, such as setting up multiple tests simultaneously |
| Invalid rate | ≤ 5% technical failure rate | ≤ 1% technical failure rate | Low invalid rate is required due to the relatively high cost of sample collection and brief site visits |
| Additional characteristics | |||
| Operating conditions | 15–40ºC, 80% relative humidity | 15–40ºC, 80% relative humidity | The test must work in tropical conditions |
| Test kit stability and storage conditions | No cold chain (15 to 30ºC), test kit stable for at least 6 months | Same as minimally essential, but stable for at least 24 months | The test components should remain stable despite unfavorable transport and storage conditions |
| Quality control | An internal control to confirm the validity of the test and processing | Same as minimally essential, but with each test having a unique identifier | The competence of the operator will vary, and incorrect use should be indicated; ID will ensure logged results are unique and correctly attributed |
| Remote connectivity capacity | No additional features | App-based communication to a central database with metadata such as GPS location | Data stored locally and transmitted upon obtaining cell signal. Compiled test results available to relevant stakeholders |
| Cost per test | Compatible with routine surveillance budgets, indicatively ≤ 5 USD per test for consumables | 1–2 USD per test for consumables | Costs exclude personnel, transport, confirmatory laboratory testing, and data management. Monitoring demand scales with the number of sites, sampling frequency, and duration of follow-up |