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Invader Factor V Assay

As part of the Hologic Invader suite of assays, Invader Factor V is an in vitro diagnostic test that simply and accurately screens for one of the four most relevant mutations associated with thrombophilia: human factor V.1-5

These innovative Invader assays detect and genotype single-point mutations in isolated genomic DNA obtained from whole blood samples.

About

Based on our Invader Plus chemistry, the Invader assays involve PCR-based target amplification followed by signal generation. Signal generation is composed of primary and secondary reactions:

  • Primary reaction — specifically and accurately detects the presence or absence of a particular target sequence.
  • Secondary reaction — used for signal amplification and result readout.

All necessary probes and oligonucleotides needed for target amplification and signal generation are included in the Invader Factor V assay kit.

Features

Adopting the Invader thrombophilia assays into your molecular testing offerings promises the following simple, cost-effective and reliable features:

  • Exceptional ease of use — common reaction conditions promote technologist proficiency.
  • Simplified analysis — dedicated software provided for quick and accurate data analysis.
  • Cost effective to adopt — uses standard laboratory equipment and instrumentation, such as thermal cyclers and fluorescence plate readers.

Confidence of reliable assays:6

  • Accurate — 99.45% or greater compared to bi-directional DNA sequencing.
  • Reproducible — 99.5% or greater between different users and sites.
  • Consistent — 100% lot-to-lot agreement.
Regulatory

The Invader Factor V test is FDA-cleared for in vitro diagnostic use in the U.S., June 1, 2011.

For additional availability in other countries beyond the U.S., please contact your local sales representative or distributor.

References
  1. Factor V Leiden Ridker PM, Miletich JP, Hennekens CH, Buring JE (1997). “Ethnic distribution of factor V Leiden in 4047 men and women. Implications for venous thromboembolism screening.” JAMA 277 (16): 1305–7.
  2. Gregg JP, Yamane AJ, Grody WW (December 1997). “Prevalence of the factor V-Leiden mutation in four distinct American ethnic populations.” American Journal of Medical Genetics 73 (3): 334–6.
  3. De Stefano V, Chiusolo P, Paciaroni K, Leone G (1998). “Epidemiology of factor V Leiden: clinical implications.” Seminars in Thrombosis and Hemostasis 24 (4): 367–79.
  4. Factor II (Prothrombin) Martinelli I, Bucciarelli P, Mannucci PM (2010). “Thrombotic risk factors: basic pathophysiology.” Crit Care Med 38 (2 Suppl): S3–9.
  5. MTHFR Varga EA, Sturm AC, Misita CP, Moll S. Homocysteine and MTHFR Mutations: Relation to Thrombosis and Coronary Artery Disease. Circulation. 2005; 111: e289-e293.
  6. Product inserts, Invader Factor V #15-3217, Rev 100, Invader Factor II #15-3216, Rev100, Invader MTHFR 677, #15-3218, Rev 100 & Invader MTHFR 1298, #15-3219, Rev 100.