Abbott NycoCard Mode D'emploi page 8

READING AND INTERPRETATION OF RESULTS
Test responses should preferably be measured
as soon as the washing solution has soaked
completely into the device. The NycoCard
D-Dimer result has to be measured within
2 minutes.
Instrumental reading
NycoCard Reader II should be used for
measuring the results. Follow the user
instruction manual.
The results are expressed as D-dimer
concentration in mg/L
This estimates the concentration of the
D-dimer fragments in the sample. To get the
results in fibrinogen equivalents (FEU), the
result obtained must be multiplied by a factor
of two.
Expected values when using
NycoCard™ D-Dimer
Normal values <0.3 mg/L
Normal subjects are expected to have a
D-dimer concentration below 0.3 mg/L.
TROUBLESHOOTING
A. If the sample is not absorbed in the test
device in less than 50 seconds, the test will give
a false high result. To obtain a correct value the
sample should be prepared before retesting
using one of the following procedures:
1. Centrifuge once more for 15 minutes at
2000 g and use plasma from the upper part
of the tube. Make sure that the speed is
2000 g (see "sample preparation").
2. Filter using a sterile filter (0.22 µm).
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Cut-off level
The cut-off level is 0.3 mg/L.
Increased values
Concentrations of approximately 0.3 mg/L or
more are regarded as pathological. Increased
levels of D-dimer in plasma indicate that
excessive amounts of fibrin have been formed
somewhere in the vascular tree.Through the
activation of the fibrinolytic system, fibrin
is degraded by plasmin to various soluble
fragments in which the D-dimer configuration
occurs.
Elevated levels of D-dimer indicate a continous
fibrinolytic process and are a key indicator of
Deep Venous Thrombosis (DVT), Pulmonary
Embolism (PE) and Disseminated Intra vascular
Coagulation (DIC) disorders.
General remarks
It is recommended to use D-dimer tests in
combination with a pre-test probability score
to rule out Venous Thromboemolism in low
or moderate risk patients. A test result that
is inconsistent with the clinical picture and
patient history should be interpreted with
cautions.
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The treatment is successful only if the sample
flow-time is reduced to less than 50 seconds.
B. The temperature will affect the test results.
Too high temperature will give elevated results,
and too low temperature will give low results.
To obtain correct results, both reagents
and samples should be at a temperature of
20-25°C.