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
thrombin generation assay hemophilia A

Hemophilia B Plasma

Despite FVIII/FIX values of <0.01IU/mL, thrombin generation shows significant differences correlating.