nal von minden NADAL D-Dimer Test Instructions D'utilisation page 6

ENGLISH
1. Intended Use
The NADAL® D-Dimer Test is used for the qualitative detection
of D-Dimer in human whole blood and plasma. The test is used
as an aid in the assessment and evaluation of patients with
suspected disseminated intravascular coa-gulation (DIC), deep
vein thrombosis (DVT) and pulmonary embolism (PE).
2. Introduction
During blood coagulation process, fibrinogen is converted to
fibrin by the activation of thrombin. The resulting fibrin
monomers polymerise to form a soluble gel of non-cross-
linked fibrin. This fibrin gel is then converted to cross-linked
fibrin by thrombin activated factor XIII to form an insoluble
fibrin clot. Production of plasmin, the major clot-lysing
enzyme, is triggered when a fibrin clot is formed. Although
fibrinogen and fibrin are both cleaved by the fibrinolytic
enzyme plasmin to yield degradation products, only
degradation products from cross-linked fibrin contain D-Dimer
and are called cross-linked fibrin degradation products.
Therefore, fibrin derivatives in human blood or plasma
containing D-Dimer are a specific marker of fibrinolysis.
The detection limit of the NADAL® D-Dimer Test is 500 ng/mL
D-Dimer.
3. Test Principle
The NADAL® D-Dimer Test (whole blood/ plasma) detects
D-Dimer through visual interpretation of color development in
the internal strip. Anti-D-Dimer antibodies are immobilized on
the test region of the membrane, and anti-mouse antibodies
are immobilized on the control region. During testing, the
specimen reacts with anti-D-Dimer antibodies conjugated to
colored particles and precoated onto the specimen pad of the
strip. The mixture then migrates through the membrane by
capillary action and interacts with reagents on the membrane.
If there is sufficient D-Dimer in the specimen, a colored band
will form at the test region of the membrane. The presence of
this colored band indicates a positive result, while its absence
indicates a negative result. The appearance of a colored band
at the control region serves as a procedural control, indication
that the proper volume of specimen has been added and
membrane wicking has occurred.
4. Reagents and Materials Supplied
 5/10/25 NADAL® D-Dimer test cassettes, incl. disposable
pipettes
 1/2/5 buffer bottle(s)
 1 package insert
5. Additional Materials Required
 Specimen collection container
 Centrifuge
 Timer
6. Storage & Stability
 The kit should be stored at 2-30°C until the expiry date
printed on the sealed pouch.
 The test must remain in the sealed pouch until use.
 Do not freeze!
 Care should be taken to protect the components of the kit
from contamination. Do not use if there is evidence of
microbial contamination or precipitation. Biological conta-
nal von minden GmbH • Carl-Zeiss-Strasse 12 • 47445 Moers • Germany • info@nal-vonminden.com • www.nal-vonminden.com
NADAL® D-Dimer Test
(Ref. 351006N-05/351006N-10/351006N-25)
mination of dispensing equipments, containers or reagents
can lead to false results.
7. Warnings and Precautions
 This kit contains products of animal origin. Certified
knowledge of the origin and/or sanitary state of the animals
does not completely guarantee the absence of transmissible
pathogenic agents. It is therefore recommended that these
products be treated as potentially infectious, and handled
observing usual safety precautions (e.g. do not ingest or
inhale).
 Avoid cross-contamination of specimens by using a new
specimen collection container for each specimen obtained.
 Read the entire procedure carefully prior to testing.
 Do not eat, drink or smoke in the area where the specimens
and kits are handled. Handle all specimens as if they contain
infectious agents. Observe established precautions against
microbiological hazards throughout the procedure and
follow standard procedures for proper disposal of speci-
mens. Wear protective clothing such as laboratory coats,
disposable gloves and eye protection when speci-mens are
assayed.
 Do not interchange or mix reagents from different lots.
 Humidity and temperature can adversely affect results.
 Used testing materials should be discarded according to
local regulations.
8. Specimen Collection and Preparation
Specimen Collection
 The NADAL® D-Dimer Test (whole blood/plasma) is
intended for use with human whole blood or plasma
specimens only.
 Only clear, non-hemolyzed specimens are recommended
for use with this test. Plasma should be separated as soon
as possible to avoid hemolysis.
 Containers containing anticoagulants such as EDTA, citrate,
or heparin should be used for whole blood storage.
 Bring specimens to room temperature prior to testing.
Frozen specimens must be completely thawed and mixed
well prior to testing. Avoid repeated freezing and thawing
of specimens.
 Icteric, lipemic, hemolysed, heat treated and contaminated
specimens may cause erroneous results.
Specimen Transport and Storage
 Perform testing immediately after specimen collection. Do
not leave specimens at room temperature for prolonged
periods. Plasma specimens may be stored at 2-8°C for up to
1 day. For long term storage, specimens should be kept
below -20°C. Whole blood collected by venipuncture should
be stored at 2-8°C if the test is to be performed within 1 day
of collection. Do not freeze whole blood specimens! Whole
blood collected by fingerstick should be tested immediately.
 If specimens are to be shipped, pack them in compliance
with all applicable regulations for transportation of
etiological agents.
9. Test Procedure
Bring tests, buffer, specimens and/or controls to room
temperature (15-30°C) prior to testing.
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