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Xpert® FII & FV

Xpert® FII & FV

Xpert® FII & FV

Product catalog summary
Introduction
The Xpert® FII & FV is a 30-minute in vitro diagnostic test designed to assess genetic risk for thrombosis by detecting Factor II (FII) and Factor V (FV) mutations. It operates on the GeneXpert® System, offering a simple and reliable solution for individuals without a background in nucleic acid diagnostics.

The Need
Thrombophilia, a condition characterized by an increased risk of blood clots, can be influenced by both genetic and acquired factors. Traditional laboratory analyses focus on detecting deficiencies in certain proteins and antibodies. Recent studies highlight the importance of FII and FV Leiden mutations in the development of deep venous thrombosis (DVT) and pulmonary embolism (PE).

The Solution
The Xpert® FII & FV test provides rapid genotyping for FII (G20210A) and FV Leiden (G1691A) mutations. It is designed for ease of use with a cartridge-based system that integrates DNA extraction, amplification, and detection. The test is clinically validated, offering results comparable to bi-directional sequencing, and can be performed on-demand with a 30-minute turnaround.

Key Features
  • Simple: All-in-one cartridge system with 24/7 availability.
  • Clinically Validated: Proven accuracy with over 1,000 patient samples.
  • Fast: Provides results in 30 minutes, facilitating same-day patient management.
  • Cost-efficient: Reduces the need for external lab services and specialized personnel.


Technology and Performance
The GeneXpert software interprets amplification curves to deliver genotyping results. The system's flexibility allows for the integration of other tests, enhancing laboratory efficiency. In a multi-center study, the test demonstrated 99.3% accuracy for detecting FV Leiden and FII G20210A mutations.

Workflow
The test involves two simple steps with less than one minute of hands-on time: pipetting the sample into the cartridge and starting the assay.

Conclusion
The Xpert® FII & FV test empowers clinical teams to manage patients more effectively by providing rapid, reliable results. It shifts laboratory operations from reactive to proactive, improving patient outcomes and laboratory service levels.
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Catalog excerpts

Xpert® FII & FV-1

Rapid and Accurate. It’s About Time. Xpert® FII & FV 30 minute test for Genetic Risk of Thrombosis C€ m In Vitro Diagnostic Medical Device A better way.

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Xpert® FII & FV-2

The GeneXpert® System is an important new development in the field of molecular diagnostics. The test is moderately complex, but the assay is simple enough to be performed reliably by individuals without a background in nucleic acid diagnostics.” Gessoni, et al. Clinica Chimica Acta, January 2012 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...

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Xpert® FII & FV-3

THE IMPACT Speed and single-test confidence to make the most efficient use of your highly-trained resources. 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 patient faster • Help more patients...

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Xpert® FII & FV-4

2 EASY STEPS Total hands-on time: <1 Minute Pipette* sample into cartridge Insert cartridge and start assay Xpert® FII & FV is a qualitative real-time PCR test for automated detection and genotyping of the FII and FV alleles directly from whole blood with results in about 30 minutes. CATALOG NUMBER Xpert FII & FV Combined Kit (10 tests) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . GXFIIFV-10 FII & FV Heterozygous DNA Control^ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . G108-2H FII & FV Genotype...

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*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.