Rox Factor IX
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Rox Factor IX (900020) is for determination of Factor IX (FIX) activity in plasma and FIX containing concentrates. Manufactured by Rossix AB.
For determination of Factor IX (FIX) activity in plasma and FIX containing concentrates. FIX is a single chain, vitamin K dependent glycoprotein of about 55 KDa, which is activated by FXIa or tissue factor / FVIIa. Activated FIX (FIXa) converts FX to FXa in the presence of FVIII, phospholipids and calcium ions.
Key characteristics
Europe and Australia: – In Vitro Diagnostic Use
Outside Europe and Australia: RUO – In Vitro Research Use Only
- Excellent dilutional linearity over the whole measuring range, also at very low Factor IX levels.
- Excellent discrimination at low Factor IX activities.
- One range, only one calibration curve is used for the whole measuring range 0 – 2 IU/mL (0-200%).
- Stability of Reagents after reconstitution 72 hours at 2-8℃.
- Reagents can be aliquoted and frozen at ≤ -70℃ in order to limit reagent waste.
- Limit of detection 0.001 IU/mL (0.1%) and limit of quantification 0.005 IU/mL (0.5%).
- Factor IX deficient plasma not needed.
- Use calibrator and control plasmas calibrated vs an international standard.
Measurement principle
FIX activity is determined in a chromogenic method, in which human FIX is activated by human FXIa and where formed FIXa activates human FX in the presence of human FVIII, calcium ions and phospholipid. Similar to in vivo conditions, FVIII is activated by thrombin which is generated during the incubation. The amount of FXa formed is related to the FIX activity and is determined from the hydrolysis of a chromogenic FXa substrate. The FIX activity of the sample is assigned vs. a FIX plasma or a FIX concentrate standard with FIX potency expressed in International Units (IU).
Kit information
- Approved for In Vitro Diagnostic Use in Europe and Australia.
- For In Vitro Research Use Only outside Europe and Australia.
- 1 Kit = 2 x 50 tests (manual microplate method).
- Limit of detection = 0.001 IU/mL (0.1%) FIX.
- Measuring range = 0 – 2 IU/mL (0-200%) FIX.
- Calibrator or Control plasmas not included – use plasmas calibrated vs. an international standard.
UKCA
