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A human thrombin, Clauss assay for fibrinogen
The FIBROTEK FIB Fibrinogen Kit is intended for use in the quantitative determination of fibrinogen in citrated human plasma.
FibroTek Fibrinogen kit is a complete kit for the Clauss determination of fibrinogen, useful in the diagnosis of DIC, liver failure, qualitative abnormalities of fibrinogen, or quantitative deficiency of fibrinogen.
|Catalog #||Product||Kit Configuration||Regulatory Classification||Product Insert (PDF)|
|70-410||FibroTek Fibrinogen kit||100-200 Det||510(k), CE||Fib_IFU|
Principle of the Test
Quantitative measurement of fibrinogen is most commonly done using the Clauss technique, in which the clotting time of dilute plasma after the addition of thrombin is measured. At high thrombin concentrations (>30 NIH units/mL) and low fibrinogen concentrations, the fibrinogen level is inversely proportional to the thrombin induced clotting time.
Bovine and human thrombins have been used successfully in Clauss assays. FibroTek uses purified human thrombin.
The FibroTek Fibrinogen test is performed by adding 1 volume of Thrombin reagent to 2 volumes of diluted patient plasma and recording the time to clot formation.
A calibration curve of clot time versus concentration in mg/dL is first determined with a plasma having a known concentration of fibrinogen, such as PlasmaRef ARN or Fib Calibrator. Thereafter the fibrinogen concentration of patient samples are calculated from their clot times using the fitted curve.
Handbooks and Guidelines
- Fibrinogen Assays, pages 215-219, in Lapasota et. al., The Clinical Hemostasis Handbook, Year Book Medical Publishers, 1989. This handbook is no longer in print, but many pathologists have a copy.
- Rogers G, Chapter 5 “Hemostasis Screening Assays”, in Laboratory Hemostasis: A Practical Guide for Pathologists, Bennet S et. al. editors, Springer 2007.
- Krishnan J, Chapter 6, “Coagulation Testing”, in An Algorithmic Approach to Hemostasis Testing, Kottke‑Marchant ed., CAP Press, 2008
- Clinical Laboratory Standards Institute, “Procedure for the Determination of Fibrinogen in Plasma; Approved Guideline – Second Edition“, CLSI document H30-A2, 2001.