Ceveron® TGA RB Kit (thrombin generation assay reagent B) is a reagent kit for use on the Ceveron® Alpha, Ceveron t100, and Ceveron s100 instruments. It can be used for:
- measurement of bleeding tendency
- researching hemophilia
- researching FVIII Inhibitor
Ceveron® TGA RB is based on monitoring the fluorescence generated by the cleavage of a fluorogenic substrate by thrombin over time, upon activation of the coagulation cascade in plasma by Ceveron® TGA RB trigger.
The trigger is composed of tissue factor and negatively charged phospholipids specially adapted to detect very sensitive changes in the positive feedback loop of intrinsic pathway activation following its activation by the extrinsic pathway. This gives the assay high sensitivity to changes in the low ranges of FVIII and FIX levels.
From the changes in fluorescence over time, the concentration of thrombin (nM) in the sample can be calculated using the respective thrombin calibration curve. The increase in thrombin concentration over time allows the calculation of the thrombin generation curve and to calculate various thrombin generation parameters.
| Reagent | Description | |
| 2x 1mL | Ceveron® TGA RB | Trigger reagent with low concentration of phospholipid micelles containing rhTF in Tris-HEPES-NaCl buffer. Lyophilized |
| 2x 1.5mL | Ceveron® TGA BUF | Tris-HEPES-NaCl buffer. Lyophilized |
| 2x 3mL | Ceveron® TGA Sub | 1 mM fluorogenic substrate Z-G-G-R-AMC. Lyophilized |
| 2x 1mL | Ceveron® CONT H | Human plasma with increased thrombin generation. Lyophilized |
| 2x 1mL | Ceveron® CONT L | Human plasma with decreased thrombin generation. Lyophilized |
| 1x 25mL | Calcium Chloride solution, 25 mM | CaCl2, 25 mM. Ready-to-Use |
Stability and Storage
The expiration date printed on the labels is applicable so long as the vials remain unopened. Stability following reconstitution:
| Reagent | Ceveron® Cooling Block | 2o-8oC |
| Ceveron® TGA RB | 8 Hours | 5 Days |
| Ceveron® TGA BUF | 8 Hours | 5 Days |
| Ceveron® TGA Sub | 8 Hours | 5 Days |
| Ceveron® CONT H | 4 Hours | – |
| Ceveron® CONT L | 4 Hours | – |
| Calcium Chloride solution, 25 mM | 7 Days | 4 Weeks |
Normal Ranges
This example normal range was determined using 100 healthy, normal donor PPP samples. Each laboratory should establish and control its normal range.
| Reagent | nM Peak Thrombin | nM AUC |
| Ceveron® TGA RB Kit | 43-368 | 1236-2945 |
Hemophilia A Plasma
Hemophilia B Plasma
Despite FVIII/FIX values of <0.01IU/mL, thrombin generation shows significant differences correlating.
