INFINITI™ Factor II-V Leiden Panel (IVD)

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

  • The INFINITI Factor II-V Leiden Panel is indicated for use as an aid to diagnosis in the evaluation of patients with suspected Thrombophilia.

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

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


Versatility
Multiplexed determination of 2 genetic variants on one
BioFilmChip Microarray
  
Efficiency
Rapid turnaround time enhances workflow efficiency
Agility
Load and Go automation with the INFINITI Analyzer
Integrity
Replicate determinations on a single BioFilmChip Microarray ensure quality results


Genetic Variants
Factor II (Prothrombin):
Factor V Leiden Leiden: 		G20210A
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
01 105
01 205
01 305
INFINITI Factor II-V Leiden Panel BioFilmChip
INFINITI Factor II-V Leiden Panel Intellipac
INFINITI Factor II-V Leiden Panel 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.1

  • The Factor V Leiden mutation is supported by a high prevalence in the general population (4-6% of US population), and accounts for 85-95% of activated protein C resistant cases. 1

  • Presence of the Factor V Leiden variant enhances the risk of venous thrombosis, with odds ratios (ORs) of 3 to 8 in heterozygotes and 30 to 140 in homozygotes.2

  • The Factor II (prothrombin) variant gene is the second most common genetic defect for inherited thrombosis.


Clinical Utility
  • "The increased risk of venous thrombosis in patients who are heterzygous for the prothrombin (G20210A) gene polymorphism is 3-fold."3

  • "Homozygotes for this polymorphism have been described but are very uncommon."3

  • Patients with a previous, or current, thrombotic event that have the prothrombin (G20210A) gene polymorphism are potentially at increased risk for recurrence.

  • “Patients with the prothrombin (G20210A) mutation are at increased risk of thrombosis when exposed to other risk factors such as:
    • (1) Smoking
    • (2) Pregnancy
    • (3) Obesity
    • (4) Oral Contraceptives
    • (5) Immobility1

  • "The risk of thrombosis is substantially increased for patients with multiple genetic risk factors (i.e. , the "double hit hypothesis") including the prothrombin (G20210A) gene mutation, Factor V Leiden Leiden mutation, hyperhomocysteinemia, methylenetetrahydrofolate reductase (MTHFR) thermolabile polymorphism, protein C deficiency, protein S deficiency, and antiphospholipid antibody Syndrome(s)."1

  • Definition and confirmation of the prothrombin (G20210A) gene polymorphism is necessary for genetic counseling of patients and family members.1


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, Arterioscler Thromb Vasc Biol. 1999;19:511-518.
3. http://pathology.mc.duke.edu/coag/PTGlflyer2.html
Copyright 2009 AutoGenomics, Inc.