Table 1.
TRL to test readiness of implementing alternative biomatrix in programmatic settings
| TRL score | Description | Interpretation in context |
|---|---|---|
| 9 | Actual system proven in operational environment | Alternative matrix proven to be used in lieu of plasma/serum for drug monitoring |
| 8 | System complete and qualified | Alternative matrix assays validated with gold-standard comparisons (i.e., with reported pharmacokinetic parameters and alternative matrix-gold standard ratios) |
| 7 | System model or prototype demonstration in operational environment | Alternative matrix assays tested in patients with tuberculosis |
| 6 | Technology demonstrated in relevant environment | Alternative matrix assays tested in healthy human volunteers ingesting study medications |
| 5 | Technology validated in relevant environment | Alternative matrix assays tested in spiked healthy human samples |
| 4 | Technology validated in laboratory | Alternative matrix assays validated in laboratory |
| 3 | Experimental proof of concept | Non-human sample proof-of-concept studies of alternative matrix |
| 2 | Technology concept formulated | Assays to quantify drug concentrations in alternative matrix developed |
| 1 | Basic principles observed | Principles of using alternative matrix observed |
Figure adapted from https://www.twi-global.com/technical-knowledge/faqs/technology-readiness-levels
TRL technology readiness level