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Factor VIII Inhibitor Testing Kit Cryocheck™ used to prepare patient samples for performing a modified Nijmegen-Bethesda assay.
Product code: CCIK08
Pack Size: Each
CE Verified: CE IVD
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Product Information
Cryocheck™ Factor VIII Inhibitor Kit
The cryocheck FVIII Inhibitor Kit is for clinical laboratory use in conjunction with a factor VIII activity assay to enable performance of a modified Nijmegen-Bethesda assay using 3.2% citrated human plasma. It enables the determination of a functional FVIII inhibitor titer to aid in the clinical management of congenital haemophilia A in individuals aged 2 years and older.
The FVIII Inhibitor Kit is used to prepare samples for the Centers for Disease Control and Prevention (CDC)modification of the Nijmegen-Bethesda assay. Factor VIII (FVIII) inhibitors are antibodies that neutralize FVIII activity in a time and temperature dependent manner. In the CDC modification of the Nijmegen-Bethesda assay, a heat inactivation of the test plasma is performed to inactivate endogenous FVIII, leaving any FVIII inhibitor antibodies intact. The inactivated test plasma is then incubated with an exogenous FVIII source (Imidazole Buffered Pooled Normal Plasma), during which time FVIII inhibitor, if present, will progressively neutralize the FVIII. By standardizing the amount of FVIII added and the incubation time, the activity of the inhibitor in the test plasma can subsequently be determined according to how much of the added FVIII is inactivated relative to a control mixture as measured by a FVIII activity assay.
FVIII inhibitor testing is used to identify and monitor the presence of FVIII inhibitory antibodies that can occur because of the use of replacement therapies for treatment of persons with haemophilia A. The presence of inhibitors results in a loss of effectiveness of a particular therapy; thus, detecting and monitoring FVIII inhibitor activity is important in the clinical management of persons with haemophilia A.
Contains 5 vial sets, enough to prepare five high titer patient samples.
Each vial set comprises:
2x 1.5ml IB-PNP (blue cap)
2 x 1.5ml IB-BSA (orange cap)
1 x 0.5ml Negative FVIII Inhibitor Control (green cap)
1 x 0.5ml Positive FVIII Inhibitor Control (red cap)
Store at -80ºC
The cryocheck FVIII Inhibitor Kit is for clinical laboratory use in conjunction with a factor VIII activity assay to enable performance of a modified Nijmegen-Bethesda assay using 3.2% citrated human plasma. It enables the determination of a functional FVIII inhibitor titer to aid in the clinical management of congenital haemophilia A in individuals aged 2 years and older.
The FVIII Inhibitor Kit is used to prepare samples for the Centers for Disease Control and Prevention (CDC)modification of the Nijmegen-Bethesda assay. Factor VIII (FVIII) inhibitors are antibodies that neutralize FVIII activity in a time and temperature dependent manner. In the CDC modification of the Nijmegen-Bethesda assay, a heat inactivation of the test plasma is performed to inactivate endogenous FVIII, leaving any FVIII inhibitor antibodies intact. The inactivated test plasma is then incubated with an exogenous FVIII source (Imidazole Buffered Pooled Normal Plasma), during which time FVIII inhibitor, if present, will progressively neutralize the FVIII. By standardizing the amount of FVIII added and the incubation time, the activity of the inhibitor in the test plasma can subsequently be determined according to how much of the added FVIII is inactivated relative to a control mixture as measured by a FVIII activity assay.
FVIII inhibitor testing is used to identify and monitor the presence of FVIII inhibitory antibodies that can occur because of the use of replacement therapies for treatment of persons with haemophilia A. The presence of inhibitors results in a loss of effectiveness of a particular therapy; thus, detecting and monitoring FVIII inhibitor activity is important in the clinical management of persons with haemophilia A.
Contains 5 vial sets, enough to prepare five high titer patient samples.
Each vial set comprises:
2x 1.5ml IB-PNP (blue cap)
2 x 1.5ml IB-BSA (orange cap)
1 x 0.5ml Negative FVIII Inhibitor Control (green cap)
1 x 0.5ml Positive FVIII Inhibitor Control (red cap)
Store at -80ºC
Specification
- Brand Precision Biologic
- Sterile N
- CE Certified CE IVD
- Warranty Period Standard Terms Apply
- Is product classified as dangerous goods? No
- Does the product contain latex? Unspecified
- Application Factor VIII Inhibitor testing
- Contents 10x 1.5ml IB-PNP (blue cap)
10 x 1.5ml IB-BSA (orange cap)
5 x 0.5ml Negative FVIII Inhibitor Control (green cap)
5 x 0.5ml Positive FVIII Inhibitor Control (red cap) - Shelf Life NULL
Storage Details
- Pack Description Each
- Shipping Condition Dry Ice
- Storage Condition -80
- Pack Length (m) 0.1
- Pack Width (m) 0.08
- Pack Height (m) 0.1
- Pack Weight (kg) 0.30