INFINITI™ Factor V Leiden (IVD)

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Product Design
  • The INFINITI™ Factor V Leiden assay is available as an in-vitro diagnostic assay, (IVD).

  • The INFINITI Factor V Leiden assay is indicated for use as an aid to diagnosis in the evaluation of patients with suspected thrombophilia.

  • The INFINITI Factor V Leiden assay is used to determine genetic variants in Factor V Leiden Leiden.

  • The INFINITI Factor V Leiden assay utilizes the Factor V Leiden Intellipac™, Factor V Leiden Amp Mix and Factor V Leiden BioFlimChip™ Microarray.

  • The INFINITI Factor V Leiden assay is automated by the INFINITI Analyzer.
Benefits


Versatility
Determination of genetic variant for Factor V Leiden
  
Efficiency
Rapid turnaround time enhances workflow efficiency
Agility
Load and Go automation with the INFINITI Analyzer
Integrity
Replicate determinations on same BioFilmChip Microarray ensures quality results


Genetic Variants
Factor V Leiden: G1691A


Genetic Variance
0.2 - 2.0 ml of Peripheral whole blood in EDTA (purple-top) tube
50 ng DNA / reaction


Product Information
  
Product No.
Product Name
Description
Pack Size
01 103
01 203
01 303
INFINITI Factor V Leiden BioFilmChip
INFINITI Factor V Leiden Intellipac
INFINITI Factor V Leiden Amp Mix 		12 BioFilmChips/magazine
24 tests/Intellipac
250 ul/vial 		4 magazines/pack
2 Intellipac/pack
4 vials/pack

Please contact AutoGenomics to obtain product information.

Clicnical Relevance
  • The Factor V Leiden mutation is the most common variant associated with inherited thrombosis.

  • This mutation has a high prevalence in the general population (4 - 6% of US Population), and accounts for 85-95% of activated protein C resistant cases.1

  • Enhanced risk of venous thrombosis, with the presence the Factor V Leiden variant, with odds ratios (ORs) of 3 to 8 in heterzygotes and 30 to 140 OR in homozygotes.2


Clinical Utility
  • The risk of thrombosis is substantially increased for patients with multiple genetic risk factors (i.e. The "double hit hypothesis") including factor V Leiden mutation, hyperhomocysteinemia, protein C deficiency, protein S deficiency and antiphospholipid antibody syndrome(s).


References
1. Grody W, Griffin J, Taylor A, Korf B, Heit, J. (2001) American College of Medical Genetics Consensus Statement on Factor V Leiden Leiden Mutation Testing, Genetics in Medicine, 3:2, 139-147.
2. Salomon O. et al; Single and Combined Prothrombotic Factors in Patients With Idiopathic Venous Thromboembolism;
3. Arteriosclerosis Thrombosis and Vascular Biology, 1999, 19: 511-518 © 1999 American Heart Association
http://pathology.mc.duke.edu/coag/PTGlflyer2.html
Copyright 2009 AutoGenomics, Inc.