CE Certified D-dimer Rapid Test Kit for Whole Blood/Plasma Diagnosis
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Detailed Product Description
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D-dimer Rapid Test Whole Blood/Plasma Diagnostic Test Kit
For professional use only. For in vitro diagnostic use only 【INTENDED USE】 D-Dimer Rapid 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 coagulation (DIC), deep vein thrombosis (DVT), and
pulmonary embolism (PE).
【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.
【PRINCIPLE】 The D-Dimer Rapid 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 immobilized on the
control region. During testing, the specimen reacts with
anti-D-Dimer antibodies conjugated to colored particles and
precoated onto the sample 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, indicating that the proper volume of specimen
has been added and membrane wicking has occurred.
【MAIN CONTENTS】 • Rapid test cassette with desiccant. • Disposable pipettes • Buffer • Package insert 【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 specimens. Wear
protective clothing such as laboratory coats, disposable gloves and
eye protection when specimens 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.
【STORAGE AND STABILITY】 • Store at 2 ~ 30 º C in the sealed pouch for 24 months. • Keep away from direct sunlight, moisture and heat. • DO NOT FREEZE.
【SAMPLE COLLECTION】 • The D-Dimer Rapid Test 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. • 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 3 days. 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 run within 2 days of collection. Do not freeze whole blood
specimens. • 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. • If specimens are to be shipped, pack them in compliance with all
applicable regulations for transportation of etiological agents. • Icteric, lipemic, hemolysed, heat treated and contaminated
specimens may cause erroneous results.
【DIRECTION OF USE】 Bring tests, specimens, and/or controls to room temperature
(15-30°C) before use. 1. Remove the test cassette from the sealed pouch and use it within
one hour. 2. Place the cassette on a clean and level surface. Hold the
dropper vertically and transfer 1 drop of sample to the specimen
area, then add 1 drop of buffer,and start the timer. See
illustration below. 3. Wait for the colored line(s) to appear. Read results at 15
minutes. Do not read results after 20 minutes.
【INTERPRETATION OF RESULTS】 POSITIVE: The presence of two lines as control line (C) and test line (T)
within the result window indicates a positive result. NEGATIVE: The presence of only control line (C) within the result window
indicates a negative result. INVALID: If the control line (C) is not visible within the result window
after performing the test, the result is considered invalid. Some
causes of invalid results are because of not following the
directions correctly or the test may have deteriorated beyond the
expiration date. It is recommended that the specimen be re-tested
using a new test. For further operation or performance details, please refer to final instruction manual.
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| Product Tags: CE Certified Rapid Test Kit Plasma Diagnosis Rapid Test Kit Whole Blood Rapid Test Kit |
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