Xpert® FII & FV
30-Minute Test for Genetic Risk of Thrombosis
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The Need

Thrombophilia is defined as an increased risk or tendency to develop blood clots as a consequence of predisposing factors that may be inherited or acquired. A thrombus may form in either the venous or arterial vascular system. Venous thrombophilia is usually related to an abnormality of the coagulation system and may result in deep venous thrombosis (DVT) or pulmonary embolism (PE).
Historically, laboratory analysis for thrombophilia has consisted primarily of detecting deficiencies of Antithrombin, Protein C and Protein S, and testing for dysfibrinogenemia and antiphospholid antibodies/lupus anticoagulants.
In the last decade it has been shown that venous thromboembolism is a complex pathology that is reliant upon the interaction of both acquired and genetic factors. In this regard, FII and FV Leiden mutations play an important role in the pathogenesis of DVT in combination with acquired factors such as age.

The Solution

Xpert® FII & FV is a qualitative genotyping test for the rapid detection of Factor II (FII) and Factor V (FV) alleles. Performed on the Cepheid GeneXpert System, the test is intended to provide rapid results for FII (G20210A) and FV Leiden (G1691A) mutations as an aid in the diagnosis of suspected thrombophilia.
  • Molecular lab in a cartridge — DNA extraction, amplification and detection in one cartridge
  • 24/7 availability — Run daily, or on-demand, with a simplified workflow
Clinically Validated
  • Proven accuracy — Multi-site study verified over 1,000 patient samples with results comparable to those obtained with bi-directional sequencing
  • On-demand: 30-minute FII and FV genotyping
  • Actionable: No added wait time to obtain complete thrombophilia work-up
  • Avoids expensive 'send-outs' to reference labs
  • Optimize labor resources- No specialized personnel or lab facilities required
Cepheid's Xpert FII & FV test provides on-demand results you can trust and empowers your clinical team to better manage patients.

The Impact

The simplified workflow requires minimal hands on time, enabling your lab technician to address other urgent needs. Accelerate your laboratory's workflow with on-demand, random-access flexibility. Combine performance with the ability to run other tests (such as GBS, MRSA, C. difficile, and Flu) on the GeneXpert® System to achieve proven increase in overall laboratory level service.
Shift your lab from reactive to proactive
  • Achieve same-day containment and improve patient management
  • Deliver same-day results to clinicians with a 30-minute, on-demand test
  • Notify patients faster
  • Help more patients live healthier lives
1. Zoller et al. Thrombophilia as a multigenic disease. Haematologica 1999; 84:59-70.
2. Tripodi et al. Laboratory Investigation of Thrombophilia. Clin Chem 2001; 47:1597-1606.
3. De Stefano et al. Screening for inherited thrombophilia: indications and therapeutic use. Haematologica 2002; 87:1095-1108.
4. Caprini et al. Laboratory markers in the diagnosis of venous thromboembolism. Circulation 2004; 109(suppl I):I-4-I-8.
5. ACMG Standards and Guidelines. Technical standards and guidelines: venous thromboembolism (Factor V Leiden and prothrombin 20210G>A testing): a disease-specific supplement to the standards and guidelines for clinical genetics laboratories. July/August 2005.
6. Kubista et al. The real-time polymerase chain reaction. Mol Aspects of Med 2006; 27: 95-125.
7. Cooper et al. An overview of methods for detection of Factor V Leiden and the prothrombin G20210A mutations. Int J Lab Hematology 2007; 29: 153-162.
8. Morelli et al. An automation experience in molecular biology: the GeneXpert Dx System for FV Leiden and FII G2010A mutations detection.Siset (Italian Society for the study of Hemostasis and Thrombosis, Florence, Italy, September 25-28, 2008)