Factor IX Testing
CRYOcheck™ Chromogenic Factor IX Kit simplifies the determination of factor IX activity in human plasma
Haemophilia B is a genetic disorder caused by missing or defective factor IX clotting protein. Although it is passed down from parents to children, about 1/3 of cases are caused by a spontaneous mutation, a change in a gene.
The CRYOcheck™ range now includes the chromogenic Factor IX assay, for use as an aid in the management of haemophilia B in individuals aged two years or older.
CRYOcheck™ Chromogenic Factor IX Assay
This new kit developed by Precision BioLogic is provided in a convenient frozen format and is designed for use on automated coagulation analysers.
It is currently available for the ACL Top family of analysers, with protocols for other analysers underway.
Providing 24 hour on-board stability, thawed reagents can be stored at 2 to 8 °C for up to 48 hours, or refrozen for up to one month, allowing allows labs of all sizes to meet their testing requirements while minimising wastage.
Applications
It is intended to be used as an aid in the management of haemophilia B in individuals aged two years or older.
Demystifying Chromogenic FIX testing
Chromogenic Assays are more complex to run than a one-stage clotting assay (OSA).
CRYOcheck chromogenic Factor FIX is the only chromogenic assay offered in a frozen format. Simply thaw the vials in a standard water bath, load them on your automated coagulation analyser, and you’re ready to go. With only four separate components, provided in convenient colour coded vials, running the assay is very straight forward.
Only large labs with high testing volumes can take advantage of a chromogenic assay .
CRYOcheck Chromogenic Factor IX comes packaged as four vial sets, each suitable for running up to 24 FIX activity assays. The ability to store unused reagents refrigerated for up to 48 hours, or frozen for up to 1 month, gives labs flexibility in how they plan their FIX testing.
Benefits
The only frozen chromogenic factir IX kit available
CE Marked
Suitable for testing extended half life FIX replacement products
Excellent linearity and LoQ of 0.7%
Product format suitable for small volume testing
Easily scalable for labs with larger test volumes
Re-freeze unused reagents for even more flexibility
Excellent on-board and refrigerated stability
Assay Performance
Performance
Based on repeated measurement of four unique negative (blank) samples and four samples from individuals with severe haemophilia, the limit of blank (LoB) was determined to be 0.4%, the limit of detection (LoD) 0.5%, and limit of quantification (LoQ) to be 0.7%.
The investigational and comparator method test results showed a correlation of >0.98 indicating that the performance of the test assay is similar to the comparator assay.
Competitive Comparison
| Supplier | Frozen | Re-freeze /Freeze | Stability Fridge* | Stability Room Temp* | Stability Freezer* | Tests per kit (approx.) | Linearity | Calibration | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Supplier | Frozen | Re-freeze /Freeze | Stability Fridge* | Stability Room Temp* | Stability Freezer* | Tests per kit (approx.) | Linearity | Calibration | Rossix | No | Yes | 72 hours | 8 hours | 12 months | 2x50 (manual method) | 0-200% | 1 curve |
| Supplier | Frozen | Re-freeze /Freeze | Stability Fridge* | Stability Room Temp* | Stability Freezer* | Tests per kit (approx.) | Linearity | Calibration | Biophen | No | Yes | 24 hours | 8 hours | 2 months | 2x10 (manual method) | 0-250% | 2 curves on CS-2000i |
| Supplier | Frozen | Re-freeze /Freeze | Stability Fridge* | Stability Room Temp* | Stability Freezer* | Tests per kit (approx.) | Linearity | Calibration | Precision BioLogic | Yes | Yes | 48 hours | 24 hours | 1 month | 4 x 24 (theoretical) | 0-200% | 1 curve |
