Siemens Healthcare Diagnostics Products GmbH B4238-40 Factor VIII Chromogenic Assay

INTENDED USEAn enzyme-linked immunosorbent assay (ELISA) for the quantitative determination of Von WillebrandFactor Antigen (VWF: Ag) in citrated human plasma. For In Vitro Diagnostic Use.SUMMARY THE TESTVon Willebrand Factor Antigen (VWF:Ag or Factor VIII-related protein) is a plasma protein found incirculation combined by non-covalent interactions with Factor VIII (FVIII:C), a pro-coagulant protein alsoknown as the anti-hemophilic factor. These two proteins show distinct biochemical and functionalproperties as well as different antigenic determinants; their plasma levels may vary independently ofeach other. Deficiency of FVIII causes classic hemophilia while deficiency of VWF causes VonWillebrand disease. VWF:Ag plays a very important role in hemostasis. The prevalence of Von Willebrand disease has been estimated to be 1-3% of thegeneral population. Approximately 80% of Von Willebrand disease patients have a type I deficiency.The laboratory diagnosis of Von Willebrand disease may require both quantitative and qualitative(functional) determinations.PRINCIPLE OF THE TESTREAADS VWF:Ag assay is a sandwich ELISA. A capture antibody specific for human VWF is coated to96-microwell polystyrene plates. Diluted patient plasma is incubated in the wells, allowing any availableVWF:Ag to bind to the anti-human VWF antibody on the microwell surface. The plates are washed toremove unbound proteins and other plasma molecules. Bound VWF:Ag is quantitated using horseradishperoxidase (HRP) conjugated anti-human VWF detection antibody. Following incubation, unboundconjugate is removed by washing. A chromogenic substrate of tetramethylbenzidine (TMB) and hydrogenperoxide (H2O2) is added to develop a colored reaction. The intensity of the color is measured in opticaldensity (O.D.) units with a spectrophotometer at 450nm. Patient VWF:Ag in relative percentconcentration is determined against a curve made from the reference plasma provided with the kit. Refer to product package insert.

CRYOcheck Chromogenic Factor IX is for clinical laboratory use in the quantitative determination of factor IX activity in 3.2% citrated human plasma. It is intended to be used in identifying factor IX deficiency and as an aid in the management of hemophilia B in individuals aged 2 years and older. For in vitro diagnostic use

The PerioLase is a FR Nd:YAG laser producing laser emission at 1064nm with variable pulse durations. The laser consists of two interconnected sections: the cabinet which houses the laser head, the power supply, the cooling system and the microprocessor with control panel; and the fiber optic delivery system which includes the Fiberflex fiber and Trueflex handpiece.

CRYOcheck Chromogenic Factor VIII is for clinical laboratory use in the quantitative determination of factor VIII activity in 3.2% citrated human plasma. It is intended to be used in identifying factor VIII deficiency and as an aid in the management of hemophilia A in individuals aged 2 years and older. For in vitro diagnostic use

Coamatic Factor VIII

ELECTRACHROME Factor VIII

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 hemophilia A in individuals aged 2 years and older.

The Factor VIII Antibody Screen is a qualitative solid phase enzyme linked immunosorbent assay (ELISA) designed to detect reactive with recombinant human factor VIII (FVIII) in human serum and plasma.

INTENDED USEAn enzyme-linked immunosorbent assay (ELISA) for the quantitative determination of Von WillebrandFactor Antigen (VWF: Ag) in citrated human plasma. For In Vitro Diagnostic Use.SUMMARY THE TESTVon Willebrand Factor Antigen (VWF:Ag or Factor VIII-related protein) is a plasma protein found incirculation combined by non-covalent interactions with Factor VIII (FVIII:C), a pro-coagulant protein alsoknown as the anti-hemophilic factor. These two proteins show distinct biochemical and functionalproperties as well as different antigenic determinants; their plasma levels may vary independently ofeach other. Deficiency of FVIII causes classic hemophilia while deficiency of VWF causes VonWillebrand disease. VWF:Ag plays a very important role in hemostasis. The prevalence of Von Willebrand disease has been estimated to be 1-3% of thegeneral population. Approximately 80% of Von Willebrand disease patients have a type I deficiency.The laboratory diagnosis of Von Willebrand disease may require both quantitative and qualitative(functional) determinations.PRINCIPLE OF THE TESTREAADS VWF:Ag assay is a sandwich ELISA. A capture antibody specific for human VWF is coated to96-microwell polystyrene plates. Diluted patient plasma is incubated in the wells, allowing any availableVWF:Ag to bind to the anti-human VWF antibody on the microwell surface. The plates are washed toremove unbound proteins and other plasma molecules. Bound VWF:Ag is quantitated using horseradishperoxidase (HRP) conjugated anti-human VWF detection antibody. Following incubation, unboundconjugate is removed by washing. A chromogenic substrate of tetramethylbenzidine (TMB) and hydrogenperoxide (H2O2) is added to develop a colored reaction. The intensity of the color is measured in opticaldensity (O.D.) units with a spectrophotometer at 450nm. Patient VWF:Ag in relative percentconcentration is determined against a curve made from the reference plasma provided with the kit. Refer to product package insert.

CRYOcheck Chromogenic Factor IX is for clinical laboratory use in the quantitative determination of factor IX activity in 3.2% citrated human plasma. It is intended to be used in identifying factor IX deficiency and as an aid in the management of hemophilia B in individuals aged 2 years and older. For in vitro diagnostic use