Table 4.
Comparison of the novel Turbo™ cell-based TBI reporter bioassay with the established, CE-marked Thyretain® TBI reporter bioasay.
| Assay characteristics | Thyretain® TBI bioassay | Turbo™ TBI bioassay |
|---|---|---|
| Platform | Cell-based cell culture lytic bioluminescent assay | Cell-based real-time, non-lytic bioluminescent assay |
| Reporting pathway | Luciferase reporter gene | cAMP reporter |
| Results | % inhibition | % inhibition |
| PPV/NPV | 94%/90% | 99%/95% |
| Samples | 21 patient samples per plate | 90 patient samples per plate |
| Sample volume | 30 µL serum required | 10 µL serum required |
| Assay temperature | 37°C/5% CO2 | Room temperature |
| Cell incubation time | Seeding and incubating of cells for 15–18 h | No need to incubate the cells |
| Serum incubation time | 3 h time for the cells to react with sera | 1 h time for the cells to react with sera |
| Assay time | ~20 h | ~2 h |
| Clearance | CE marked | CE marked |
| Feasibility | High-complexity labs | Moderate-complexity labs |