Method, reagent, cartridge, and device for determining fibrinogen
AssigneeRoche Diagnostics GmbH
InventorBerndt B. Bruegger
Life of this patent
Estimating the term…
Abstract
The invention is a method, reagent, test cartridge and device for the determination of fibrinogen in a sample, such as undiluted blood and blood plasma. The method utilizes a reagent comprising thrombin and a thrombin inhibitor that slows the enzymatic conversion of fibrinogen to fibrin, and thus slows clotting in samples. This is particularly useful for determining fibrinogen in undiluted blood and blood plasma. Fibrinogen assay reagents comprising at least one thrombin inhibitor and thrombin, and test cartridges containing the reagents for automated analysis of fibrinogen are disclosed, along with automated devices using said reagent and test cartridges for the devices.
Claims57
A method for determining fibrinogen in a sample suspected of comprising fibrinogen, comprising contacting a sample suspected of comprising fibrinogen with at least one reagent comprising a thrombin inhibitor and thrombin, and determining the clotting time, whereby the concentration of fibrinogen in the sample is inversely related to the clotting time.
A reagent for use in determining fibrinogen in a sample suspected of containing fibrinogen, said reagent comprising a thrombin inhibitor and thrombin, wherein when a sufficient amount of said reagent is combined with a sample having a fibrinogen concentration ranging from about 0.5 mg/dL to about 2000 mg/dL the time for the sample to reach a predetermined degree of clotting is less than about 300 seconds and the concentration of fibrinogen in the sample can be correlated with the time required to achieve the predetermined degree of clotting.
A test cartridge for use in determining fibrinogen in a sample containing a thrombin inhibitor, comprising:
- a housing containing an inlet port, a chamber unit and an exit port, said inlet port, chamber unit and exit port are present in a continuous capillary pathway;
- and
- a reagent in said capillary pathway, said reagent comprising thrombin.
A device for use in determining fibrinogen in a sample suspected of containing fibrinogen, comprising:
- a vessel for contacting a sample suspected of containing fibrinogen with a reagent that causes conversion of fibrinogen to fibrin thereby causing clotting,
- a sensor for detecting a predetermined degree of clotting,
- a timer for determining the amount of time for a predetermined degree of clotting to be reached,
- a processor that converts clotting time to the amount of fibrinogen in a sample, and
- a display that can report the amount of fibrinogen in a sample.
Dependencies are inferred from the claim text.