||Conditioning||Package size ||
|5-950030||kit||2 x 50 ||
A chromogenic kit for quantitative determination of human Factor IXa (FIXa) activity as contamination in human Factor IX (FIX) containing concentrates.
FIXa activity in FIX containing concentrates is determined in a chromogenic method, in which human FX is activated by contaminating human FIXa in the FIX concentrate in the presence of FVIII, thrombin, calcium ions and phospholipid. The amount of generated human FXa is determined from the hydrolysis of a chromogenic FXa substrate. The sample FIXa activity is determined by the slope ratio model in which the potency of the sample is calculated vs. a FIXa standard with potency expressed in International Units (IU).
- 2 vials of Reagent 1 (Human Factors VIII and X)
- 2 vials of Reagent 2 (Human Thrombin, CaCl₂ and phospholipids)
- 1 vial of chromogenic FXa Substrate, 6 mL
- 1 bottle of FIXa Diluent Buffer, Stock Solution, 20 mL
The kit method comprises activation of human FX by sample FIXa in the presence of FVIII, thrombin, calcium ions and phospholipids. Generated FXa is directly proportional to the FIXa activity in the sample and is measured through hydrolysis of a chromogenic FXa substrate.