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Xpert® FII & FV
30-Minute Test for Genetic Risk of Thrombosis
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GXFIIFV-10
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The Need
Thrombophilia is as an increased risk or tendency to develop blood clots (thrombi) in veins, arteries or both due to either inherited or acquired defects.1 The high incidence of venous thrombo-embolism (VTE) in hospitalized patients is a major cause of sudden death.2 Factor II and V are the two most common genetic variants associated with VTE and testing for these variants is the most common referral in clinical genetics laboratories.1-3
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).3
Research shows that venous thromboembolism is a complex pathology that is reliant upon the interaction of both acquired and genetic factors.4 The most commonly associated genetic mutations for inherited thrombophilia are mutations in the genes for Factor V Leiden and Factor II (prothrombin).3-5
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).3
Research shows that venous thromboembolism is a complex pathology that is reliant upon the interaction of both acquired and genetic factors.4 The most commonly associated genetic mutations for inherited thrombophilia are mutations in the genes for Factor V Leiden and Factor II (prothrombin).3-5
1 Mannucci P.M et al. Classic thrombophilic gene variants. Thromb Haemost. 2015 Nov;114(5):885-9.
2 Heit J et al. The epidemiology of venous thromboembolism. J Throm Thrombolysis 2016 41: 3-14 CDC. Accessed Aug 2020 https://www.cdc.gov/ncbddd/dvt/facts.html
3 Zhang S et al. Venous thromboembolism laboratory testing (factor V Leiden and factor II c.*97G>A), 2018 update: a technical standard of the American College of Medical Genetics and Genomics (ACMG). Genet Med. Oct 2018;20(12):1489–1498.
4 Saquilayan M et al. Detection of genetic thrombophilia (Fa V Leiden & PT20210 mutation) using GeneXpert technology with IQCP implementation. Natural Sciences and Mathematics | Clinical Laboratory Sciences Culminating Projects. 2019. https://doi.org/10.33015/dominican.edu/2019.CLS.04
5 Xpert® Factor II & Factor V Kit Instructions for Use. 301-0590.
The Solution
The Xpert FII & FV is intended to provide results for Factor II mutation c.*97G>A (formally 20210G>A) and Factor V Leiden c.1601G>A (Arg506Gln) mutations as an aid in the diagnosis of suspected thrombophilia.5 The test is a qualitative genotyping test for fast and simultaneous detection of Factor II and Factor V alleles in approximately 30 minutes.5
Simple
Simple
- Molecular lab in a cartridge: DNA extraction, amplification and detection in one cartridge
- 24/7 availability — Run daily, or on-demand, with a simple workflow
- Proven accuracy: Multi-site study verified over 1,000 patient samples with results comparable to those obtained with bi-directional sequencing6
- On-demand: 30-minute FII and FV genotyping
- Actionable: Avoid costly ‘send out’ testing, and associated wait for results. Improve patient management with fast test answers on-demand.
- Avoid expensive ‘send-outs’ to reference labs
- Optimized: Cartridge-based testing system removing the risk of non-optimal reagent use associated with batch testing.
- Efficient: No requirement for specialized lab personnel or facilities. Just add blood sample to the cartridge and get results in 30 minutes.
6. Xpert® Factor II & Factor V Kit Package Insert
The Impact
The simple workflow requires minimal hands on time, enabling lab technicians 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 on the GeneXpert® System to increase overall laboratory-level service.
Shift your lab from reactive to proactive
Shift your lab from reactive to proactive
- Improves patient management and optimizes lab workflow with fast test and accurate results that doesn’t require specialized lab personnel or facilities.4
- Delivers fast answers on the two main factors involved in VTE enabling timely clinical management.1-3
- Facilitates labs and clinicians compliance with guidelines.3
1 Mannucci P.M et al. Classic thrombophilic gene variants. Thromb Haemost. 2015 Nov;114(5):885-9.
2 Heit J et al. The epidemiology of venous thromboembolism. J Throm Thrombolysis 2016 41: 3-14 CDC. Accessed Aug 2020 https://www.cdc.gov/ncbddd/dvt/facts.html
3 Zhang S et al. Venous thromboembolism laboratory testing (factor V Leiden and factor II c.*97G>A), 2018 update: a technical standard of the American College of Medical Genetics and Genomics (ACMG). Genet Med. Oct 2018;20(12):1489–1498.
4 Saquilayan M et al. Detection of genetic thrombophilia (Fa V Leiden & PT20210 mutation) using GeneXpert technology with IQCP implementation. Natural Sciences and Mathematics | Clinical Laboratory Sciences Culminating Projects. 2019. https://doi.org/10.33015/dominican.edu/2019.CLS.04
2 Heit J et al. The epidemiology of venous thromboembolism. J Throm Thrombolysis 2016 41: 3-14 CDC. Accessed Aug 2020 https://www.cdc.gov/ncbddd/dvt/facts.html
3 Zhang S et al. Venous thromboembolism laboratory testing (factor V Leiden and factor II c.*97G>A), 2018 update: a technical standard of the American College of Medical Genetics and Genomics (ACMG). Genet Med. Oct 2018;20(12):1489–1498.
4 Saquilayan M et al. Detection of genetic thrombophilia (Fa V Leiden & PT20210 mutation) using GeneXpert technology with IQCP implementation. Natural Sciences and Mathematics | Clinical Laboratory Sciences Culminating Projects. 2019. https://doi.org/10.33015/dominican.edu/2019.CLS.04
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