Quantitative determination of Fibrinogen
IVD
Store at 2-8ºC
PRINCIPLE OF THE METHOD
Fibrinogen in presence of an excess of thrombin concentration,
changes into Fibrin.
The time for clot formation in dilute plasma is inversely proportional to
the fibrinogen concentration in the sample.
The thrombin clotting time fibrinogen assay is based on the method
originally described by Clauss.1
In the presence of high concentrations
of thrombin, the time required for clot formation in dilute plasma is
inversely proportional to the fibrinogen concentration.
CLINICAL SIGNIFICANCE
Fibrinogen (Factor I), protein synthesized by the liver, is the
substance used in the blood to form a clot. Its determination is used to
evaluate abnormal blood clotting.
Elevated Fibrinogen levels are observed in acute inflammations and in
pregnancy; low values are observed in trombolitic therapy, in hepatic
disease, in the congenital non fibrinogen, in DIC (Disseminated
Intravascular Coagulation) and in pancreatitis (low values)1.
Clinical diagnosis should not be made on a single test result; it should
integrate clinical and other laboratory data.
PREPARATION
R1: Dissolve ( ) the vial content with 1.5 mL of distilled water and
0.5 mL of caolin solution, previously mixed . Cap and mix thoroughly
avoiding foam forming to dissolve the total content, 15 minutes..
Stability: 7 days at 2-8ºC or 1 month at –20ºC, if stored in the original
container and immediately frozen once reconstituted. Do not re-freeze
once thawed.
Introduce the magnetic stirrer in the vial before to use the reagent in
the analyzer.
R2: Ready for use. Mix thoroughly before use.
Both reagent positions are defined in the reagent’s paragraph of
Biobas 1000.
TRACEABILITY
The Coagulation Calibrator is traceable for Fibrinogen to the WHO
standard, 2nd International Standard for Fibrinogen, plasma (98/612).
STORAGE AND STABILITY
All the components of the kit are stable until the expiration date on the
label when stored tightly closed at 2-8ºC and contaminations
prevented during their use.
Do not use reagents over the expiration date.
Signs of reagent deterioration:
- Presence of particles and turbidity.
- Quality control values outside established ranges.
- Product colour variations.
ADDITIONAL EQUIPMENT
- BIOBAS 1000.
- BIOBAS 1000 consumables.
- General laboratory equipment(Note 1).
SAMPLES
Plasma from venous puncture diluted 1/10 in trisodium citrate solution
3.8% (105 mmol/L).
Mixing immediately the blood with anticoagulant. Avoid foaming the
specimen. Centrifuge the sample at 3000 x g for 10 min and transfer
the plasma to siliconized glass or plastic containers.
