nal von minden NADAL D-Dimer Test Instructions D'utilisation page 7

ENGLISH
1. Remove a test cassette from the foil pouch and use it as
soon as possible. The best results will be obtained if the
test is performed immediately after opening the foil pouch.
Label the test cassette with the patient's name or control
identification.
2. Place the test cassette on a clean and level surface.
3. a) For plasma specimens:
Holding a pipette vertically,
add 1 drop (approximately
25 μL) of the plasma
specimen to the specimen
well (S) of the test cassette.
b) For venipuncture whole
blood specimens:
Holding a pipette vertically,
add 2 drops (approximately
50 μL) of the whole blood
specimen to the specimen
well (S) of the test cassette.
c) For fingerstick whole
blood specimens:
Position the patient's finger
so that a drop of blood is
exactly above the specimen
well (S) of the test cassette.
Allow 1 hanging drop of
fingerstick whole
(approximately 50 μL) to fall
into the centre of the
specimen well (S) of the test
cassette.
4. Holding the buffer bottle
vertically, add 1 drop of
buffer to the specimen well
(S) of the test cassette.
5. Start the timer.
6. Wait for the coloured line(s)
to appear. Read the test
result after 10 minutes. Do
not interpret the result after
more than 20 minutes.
10. Result Interpretation
Positive result
Two coloured lines appear on the
membrane. One line appears in the
control line region (C) and the other
line appears in the test line region (T).
Note:
The colour intensity in the test line region (T) may vary
depending on the concentration of the analyte present in the
specimen. Therefore, any shade of colour in the test line
region (T) should be considered positive. Note that this is a
qualitative test only and it cannot determine the analyte
concentration in the specimen.
nal von minden GmbH • Carl-Zeiss-Strasse 12 • 47445 Moers • Germany • info@nal-vonminden.com • www.nal-vonminden.com
NADAL® D-Dimer Test
blood
(Ref. 351006N-05/351006N-10/351006N-25)
Negative result
One coloured line appears in the
control line region (C). No apparent
coloured line appears in the test line
region (T).
Invalid result
The control line (C) fails to appear.
Results from any test which has not
produced a control line at the specified
reading time must be discarded. Please
review the procedure and repeat the
test with a new test cassette. If the
problem persists, discontinue using the
test kit immediately and contact your
distributor.
Note:
Insufficient specimen volume, incorrect operating procedure
or expired tests are the most likely reasons for control line
failure.
11. Quality Control
 Internal procedural controls are included in the test. A
colored band appearing in the control region (C) is
considered an internal positive procedural control,
confirming sufficient specimen volume and correct
procedural technique.
 External controls are not supplied with this kit. It is
recommended that positive and negative controls be tested
as a good laboratory practice to confirm the test procedure
and to verify proper test performance.
12. Limitations
 The NADAL® D-Dimer Test (whole blood/ plasma) is for
professional in-vitro diagnostic use and should only be used
for the qualitative detection of D-Dimer.
 Clinical diagnosis should not be based on the result of the
D-Dimer rapid test only. The full clinical context of the
patient should be included when making a diagnostic
decision, taking into account the clinical signs and other
relevant information such as the «Well's pre-test
probability score» or equivalent.
 Negative D-Dimer results can occur very occasionally even
in the presence of a DVT due to other factors including the
age or position of a clot, heparin therapy and when the
D-Dimer concentration is below the sensitivity of the test.
13. Expected Values
Elevated levels of D-Dimer are an indication of active
fibrinolysis and have been shown in patients with
disseminated intravascular coagulation (DIC), deep vein
thrombosis (DVT) and pulmonary embolism (PE). Elevated
levels of D-Dimer have also been reported in surgery, trauma,
sickle cell disease, liver disease, severe infection, sepsis,
inflammation, malignancy and in the elderly. D-Dimer levels
also rise during normal pregnancy but very high levels are
associated with complications.
14. Performance Characteristics
Analytical sensitivity
The detection limit of the NADAL® D-Dimer Test is 500 ng/mL
(fibrinogen equivalent units: FEU). No hook effect was
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