Abbott NycoCard Mode D'emploi page 5

NycoCard
For professional near-patient testing and laboratory use. For use with the NycoCard
The NycoCard Reader II is calibrated for use with the NycoCard Tests only.
PRODUCT DESCRIPTION
Intended use
NycoCard D-Dimer is an in vitro test for the
™
rapid determination of the fibrin degradation
product D-dimer in plasma.
Test principle
NycoCard D-Dimer is based upon an immuno-
metric flow-through principle. The plasma sample
is applied to the test well of the device. When the
sample has soaked into the device, D-dimer
molecules are trapped on a membrane carrying
D-dimer specific monoclonal antibodies. The
conjugate solution then added, contains D-dimer
specific monoclonal antibodies conjugated with
ultra-small gold particles.
The D-dimer on the membrane will bind the
gold-antibody conjugate in a sandwich-type
reaction. The excess conjugate is removed from
the membrane by the washing solution.
In the presence of D-dimer levels above
0.1 mg/L in the sample, the membrane appears
reddish with a colour intensity pro portional to
the D-dimer concentration. The color intensity
is evaluated using NycoCard Reader II.
D-DIMER
™
NycoCard D-Dimer
Kit contents, 24 tests
TD/Test Device
Plastic device containing a membrane coated
with monoclonal anti-D-dimer antibodies.
R1/Conjugate
Dark bottle with black cap. Buffered solution
containing anti- D-dimer antibodies labelled with
ultrasmall gold particles.
R2/Washing Solution
Bottle with white cap. Buffered solution
(pH 8.0) with BSA and detergents.
C/Positive Control
Bottle with white cap. Buffered solution of fibrin
degradation products with BSA and stabilizers.
Value: See "range" printed on the vial label.
Material required but not provided:
• 50 µL pipette and pipette tips
• NycoCard Reader II
Warnings and precautions
in vitro
• For diagnostic use.
• The reagents
(< 0.1%) as a preservative. Azide is a toxic
reagent. Avoid contact with eyes and skin. Flush
abundantly with water upon disposal and if
reagents are spilled over.
• The positive control is produced from blood
proteins thoroughly controlled and found
negative for HB s antigen, HCV antibodies and
HIV antibodies.
In spite of the negative test for HB s antigen,
HCV antibodies and HIV antibodies the control
should be handled as patient blood samples.
Reader II.
™
1 x 24 units
1 x 2.0 mL
1 x 4.5 mL
1 x 1.0 mL
contain sodium
EN
azide
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