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.
PRECAUTIONS
R2: H290- May be corrosive to metals. H302-Harmful if swallowed. H360-
May damage fertility or the unborn child. H412-Harmful to aquatic life with
long lasting effects
Follow the precautionary statements given in MSDS and label of the
product.
PREPARATION
R1: Dissolve the contents with 2.0 mL of distilled water. Cap vial and
mix gently to dissolve contents. Stability: 7 days at 2-8ºC or 1 month at –
20ºC, if immediately frozen and stored in the original container. Do not refreeze.
R2: Mix before use. R3: Ready for use reagent.
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
- Coagulometer or stopwatch and bath at 37ºC ± 0.5ºC.
- 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.
Turbid, icteric, lipemic or hemolyzed samples may generate erroneous
results.
The sample is stable for 4 hours at room temperature (15-25ºC) or 28 days
if immediately frozen at below 20ºC.
NOTES
1. All labware must be clean and free of trace amounts of detergents.
2. Always follow instrument manufacturer’s instructions; the results must
be validated by the test laboratory.
PROCEDURE
The reagent can be used by manual procedure, mechanical, photo-optical
or other means of end clot detection(Note 2).
