FIBRIPHEN™ LRT
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FIBRIPHEN™ LRT (CK585K) is a clotting method for quantitative determination of Fibrinogen in human citrated plasma, using an automated method. Manufactured by HYPHEN BioMed.
The FIBRIPHEN™ LRT (CK585K) kit is a clotting method for in vitro quantitative determination of Fibrinogen in human citrated plasma (Clauss method), using manual or automated method. Reagents are in the liquid presentation, ready to use (LRT, Liquid Reagent Technology).
Intended Use
Clotting method based on Clauss method for the in vitro quantitative determination of Fibrinogen in human citrated plasma, using an automated method. This method is an aid to diagnosis of Fibrinogen abnormalities in patients who are suspected of congenital or acquired disorders.
This device of in vitro diagnostic use is intended for professional use in the laboratory.
Summary and Explanation
Technical: Fibrinogen is a 340 Kd soluble plasma glycoprotein, synthesized in the liver, containing 6 peptidic chains, with a 2 to 2 symmetry, and linked by disulfide bridges (2 Aα, 2 Bβ and 2γ chains). Thrombin clots fibrinogen and forms fibrin, which is then stabilized by activated Factor XIII in presence of calcium. Fibrinogen is lysed by plasmin to fragments X and Y, first, then D and E.
Clinical: Congenital or acquired Fibrinogen disorders may affect its level or function. Clauss method is for the quantification of functional Fibrinogen. Hypofibrinogenemia is mainly associated with severe liver disease, or excessive consumption of fibrinogen (DIC, hyperfibrinolysis) and certain others treatments. Numerous variants (eg afibrinogenemia, hypofibrinogenemia, dysfibrinogenemia) of fibrinogen have been described, associated to asymptomatic cases, or to cases with bleeding and/or thrombosis.
Fibrinogen is an acute phase reactant. Increased concentrations are observed in various clinical situations associated with inflammation, cancers and have also been considered as a risk factor for cardiovascular disease events and thrombosis, nonvascular mortality.
Principle
In the presence of a constant and in excess amount of bovine thrombin, the clotting time (CT) obtained for diluted citrated plasma is inversely proportional to the plasma fibrinogen concentration.
UKCA
