Human health

ThromboGUARD FII FV PCR Kit

Kit for multiplex detection of FII / FV thrombophilia by real-time PCR

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ThromboGUARD FII FV is intended for use in the non-automated qualitative detection and
genotyping of mutations in the genes encoding coagulation factor
II (prothrombin) and factor V (“factor V Leiden”) in
a blood sample, to aid in the diagnosis of hereditary thrombophilia
.
Polymerase Chain Reaction (PCR)
PCR), amplification of two specific regions of the
human genome and detection by scatter plot analysis
plot) based on fluorescence using TaqMan™ probes
MGBs labeled with specific fluorophores for :
– Factor II: G20210A (gene)
– Factor V: G1691A (gene)

Extraction:
Automate QIAsymphony SP
(Ref: 9001297)(extractor)* – QIAGEN
Thermocycler:
Thermocycler CFX Opus 96
Dx Real-Time PCR with Bio-Rad CFX Maestro Dx SE software version 2.0

Kit undergoing CE-IVDR certification

Indication

non-automated qualitative detection and genotyping of mutations in genes coding for coagulation factor II (prothrombin) and factor V (“factor V Leiden”) in a blood sample

Principle

Real-time PCR using scatter plot analysis

Withdrawal

Whole blood in a single-use sterile vacuum blood collection tube containing EDTA K2 anticoagulant, for collection and storage of samples for in vitro diagnostic purposes.

Target sequences

– Factor II: G20210A (gene) – Factor V: G1691A (gene)

Specific

100% ; 95% CI (100% ;100%)

Sensitivity

100% ; 95% CI (100% ;100%)

Storage (t°C)

-20°C

Catalog number

AB0023

Packaging

24 tests

Manufacturer

Appolon Bioteck

Country

France

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If you have any questions or would like to discuss our services, we invite you to contact us. Our team is always available to assist you, 7 days a week, and is committed to responding to all your requests in less than 24 hours.

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Any questions?

At ThromboGUARD FII FV PCR Kit, we understand the regulatory challenges faced by our French customers. We offer support in your accreditation process, including assistance in preparing the files needed to validate new techniques. Our approach is to provide local support, with flexibility and adaptability.

We are ISO 13485:2016 certified, demonstrating our commitment to the highest international standards for medical devices. What’s more, all our products are designed and manufactured in France, guaranteeing a high level of expertise and quality control.

We maintain a strategic buffer stock for all our distributed products, minimizing the risk of stock-outs. Should the need arise, our Lyon-based after-sales service is ready to react quickly to ensure your business continues uninterrupted.

Our logistics are optimized for rapid delivery throughout France and internationally. With efficient processes and a well-established distribution network, we ensure that your orders reach you in the shortest possible time.

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  • 205, rue des frères Lumière 69970 CHAPONNAY
    France
  • +33 (0)4 37 57 00 54
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