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Xpert® FII & FV
30-Minute Test for Genetic Risk of Thrombosis
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10 Tests
GXFIIFV-10
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The Need
Thrombophilia is defined as an increased risk or tendency to develop blood clots (thrombi) as a consequence of predisposing factors that may be inherited or acquired.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. De Stefano et al. Screening for inherited thrombophilia: indications and therapeutic use. Haematologica 2002; 87:1095-1108.
3. 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
4. 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.
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.
2. De Stefano et al. Screening for inherited thrombophilia: indications and therapeutic use. Haematologica 2002; 87:1095-1108.
3. 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
4. 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.
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.
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 Factor II c.*97G>A (G20210A) and Factor V Leiden c.1601G>A (G1691A or R506Q) mutations as an aid in the diagnosis of suspected thrombophilia.
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
- Deliver same-day results to clinicians with a 30-minute, on-demand test
- Improve patient experience and ease anxiety with fast and accurate results
Test 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)
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)
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