Diagnostic Coagulation Test Kits

VisuLize™ FVIII Antigen ELISA Kit
The VisuLize™FVIII Antigen Kit is intended to quantitatively measure factor VIII antigen in human plasma and factor concentrates. The biological importance of factor VIII is demonstrated in Hemophilia A and those patients suspected of thrombophilia. The laboratory diagnosis of factor VIII deficiency in Hemophilia A typically involves quantitative determination of factor VIII’s functional activity. The use of this kit in conjunction with functional assays in the area of gene therapy, assessment of factor VIII concentrates, as well as distinguishing those patients with cross-reactive material will prove useful in the area of Hemophilia A. Additionally as documented in numerous studies, elevated levels of factor VIII is being recognized as a common risk of venous thrombosis¹, an area where Affinity’s VisuLize™ FVIII Antigen Kit has utility.

The VisuLize™ FVIII Antigen Kit is FDA cleared for diagnostic use.

1.O’Donnell J, Tuddenham EG, Manning R, Kemball-Cook G, Johnson D, Laffan M. High prevalence of elevated factor VIII levels in patients referred for thrombophilia screening: role of increased synthesis and relationship to the acute phase reaction. Thromb Haemost. 1997;77:825–828.

Features:

  • Rapid sandwich ELISA to measure FVIII antigen (FVIII:Ag)
  • 1 hour 55 minutes total incubation time!
  • FVIII:Ag reported as International Units/ml traceable to WHO standard for FVIII antigen
  • Detection limit to 0.008 IU/ml FVIII:Ag (0.8%)
  • Includes normal and low controls
  • Shelf-life: 18 months

Applications:

  • Quantification of FVIII in plasma and therapeutic concentrates
  • Diagnosis and characterization of Hemophilia A
  • Carrier testing for Hemophilia A
  • Thrombophilia screening

Product Catalogue No. Size Product Insert
VisuLize™ FVIII Antigen ELISA Kit FVIII-AG 1 plate Factor VIII, F8 Antigen Kit for ELISA - quantitative determination of Factor VIII antigen in human plasma

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VisuLize FIX Antigen Kit
The VisuLize™ FIX Antigen Kit is intended to quantitatively measure factor IX antigen in human plasma and factor concentrates. The biological importance of Factor IX is demonstrated in Hemophilia B (Christmas disease), an X-linked congenital bleeding disease resulting from a quantitative (low activity and low antigen) or qualitative (low activity and normal antigen) defect in Factor IX function. The congenital deficiency of Factor IX may be classified as severe (1% Factor IX activity), moderate (between 1 and 5% Factor IX activity) or mild (between 5 and 40% Factor IX activity). The laboratory diagnosis of Factor IX deficiency typically involves quantitative determinations of procoagulant levels i.e., functional activity of Factor IX.¹ An ELISA for Factor IX antigen may be used in conjuction with functional assays in the area of gene therapy, assessment of Factor IX concentrates, determination of carrier status as well as distinguishing those patients with cross-reactive material (i.e., low functional activity but near normal antigen levels of Factor IX).

The VisuLize™ FIX Antigen Kit is FDA cleared for diagnostic use.

1. White GC, Roendaal, F. Aledort LM, Lusher JM, Rothschild C, Ingersley J. Definitions in Hemophilia, Recommendation of the Scientific Subcomittee on Factor VIII and Factor IX of the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis, Thrombosis and Haemostasis, 2001, 85, p. 560.

Features:

  • Rapid sandwich ELISA to measure FIX antigen (FIX:Ag)
  • 70 minutes total incubation time!
  • FIX:Ag reported as International Units/ml traceable to WHO standard for FIX activity
  • Detection limit to 0.005 IU/ml FIX:Ag (0.5%)
  • Includes normal and low controls

Applications:

  • Quantification of FIX in plasma and therapeutic concentrates
  • Diagnosis and characterization of Hemophilia B
  • Carrier testing for Hemophilia B
  • Thrombophilia screening
 
Product Catalogue No. Size Product Insert
VisuLize™ FIX Antigen ELISA Kit FIX-AG 1 plate