Quantitative measurement of D-dimer in human plasma or
serum
IVD
Store 2 - 8ºC.
PRINCIPLE OF THE METHOD
D-dimer in the sample reacts with the anti-human D-dimer mouse monoclonal
antibody-coated latex, resulting in agglutination and elevation of turbidity. The
resulting turbidity changes are then measured using a spectrophotometer,
allowing quantitative measurement of the D-dimer concentration in the
sample.
CLINICAL SIGNIFICANCE
D-dimer is a type of fibrin degradation products (FDP) composed of stable
fibrin degraded by plasmin. Stable fibrin is crosslinked by the action of
coagulation factor XIII in the blood coagulation and fibrinolysis system.
Various types of D-dimer molecules exist in the blood, including YY/DXD,
YD/DY, DD/E and DD complex.
Increasing in the level of D-dimer in the blood proves thrombus production, as
well as the efficacy of fibrinolysis. Increasing in the level of D-dimer is also
known to be associated with various diseases, including malignant tumors,
obstetric diseases, vascular lesions, and DIC (disseminated intravascular
coagulation syndrome).
PRECAUTIONS
R1: EUH208-Contains Proclin300. May produce an allergic reaction. EUH210-
Safety data sheet available on request
Follow the precautionary statements given in MSDS and label of the product.
Components from human origin have been tested and found negative for the
presence of HBsAg, HCV and antibody to HIV (1/2). However, handle cautiously as
potentially infectious.
PREPARATION
Reagents: Ready to use.
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 are prevented during
their use. Do not use reagents over the expiration date.
Frozen Latex and Diluent could change the functionality of the test.
Protect the reagents from direct sunlight.
Reagent deterioration: Presence of particles and turbidity.
ADDITIONAL EQUIPMENT
- Thermostatic bath at 37ºC.
- Spectrophotometer or photometer thermostatable at 37ºC with a 570 nm
filter (560 – 580 nm).
SAMPLES
Serum or citrated plasma can be used. When using serum, whole blood
should be collected with the specific tube for FDP containing thrombin and
aprotinin.
Stable 1 day at 2-8ºC and 1 month at -80ºC.
Do not repeat the freeze-thaw cycle for samples.
PROCEDURE
1.Bring the reagents and the photometer (cuvette holder) to 37ºC.
2.Assay conditions:
Wavelength: 570 nm (560-580 nm)
Temperature: 37 ºC
Cuvette ligth path: 1cm
3.Adjust the instrument to zero with distilled water
