Abbott NycoCard Mode D'emploi page 6

Analytical specificity
Monoclonal antibodies specific to a neo-
antigen on the D-dimer structure are used in
the test. Plasma components such as fibrinogen
and fibrin monomer do not cross-react with
the D-dimer in the test system. NycoCard
D-Dimer can therefore be considered to be
specific for fibrin degradation products.
Standardization
No international standard is available.
NycoCard D-Dimer has been calibrated
against a commercially available D-dimer
ELISA-test.
Measuring range
Measuring range: 0.1–20.0 mg/L with
NycoCard Reader II
Measuring intervals: 0.1 mg/L
Calibrated measuring range: 0.1–10.0 mg/L
STABILITY AND STORAGE
The expiry date of the kit applies to pro duct
stored at 2-8°C.
Exposure to temperatures above 25°C, direct
sunlight or high humidity should be avoided.
Do not freeze.
Test device
The test device is stable until expiry date at
2-8 °C. The sealing foil should be removed
immediately before use.
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Precision
In professional use, a coefficient of variation
(CV) ≤ 15% in the measuring range below
10 mg/L and > 15% in the measuring range
above 10 mg/L, is usually obtained.
Limitation of the test
Increased values of bilirubin and haemoglobin
will not have any effect on the results. Samples
containing cells or platelets, high lipid levels,
or samples with high viscosity, may be over-
estimated due to reduced flow rate. Such
samples should be sterile filtered or centrifuged
once more. Only citrate should be used as
anticoagulant.
Reagents and positive control
The expiry date printed on the labels applies
to storage of the unopened bottles at 2-8°C.
After the bottles are opened, the reagents are
stable for 3 months. Caps should be screwed
tightly after use.