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CE Certified D-dimer Rapid Test Kit for Whole Blood/Plasma Diagnosis

CE Certified D-dimer Rapid Test Kit for Whole Blood/Plasma Diagnosis
CE Certified D-dimer Rapid Test Kit for Whole Blood/Plasma Diagnosis
CE Certified D-dimer Rapid Test Kit for Whole Blood/Plasma Diagnosis CE Certified D-dimer Rapid Test Kit for Whole Blood/Plasma Diagnosis CE Certified D-dimer Rapid Test Kit for Whole Blood/Plasma Diagnosis CE Certified D-dimer Rapid Test Kit for Whole Blood/Plasma Diagnosis
Basic Information
Place of Origin: China
Brand Name: Dewei
Certification: ISO, CE
Model Number: DDM-DW02
Minimum Order Quantity: 3000 units
Price: Negotiable
Packaging Details: 25test/box, 40test/box
Delivery Time: in 20 days
Payment Terms: L/C, T/T, Western Union
Supply Ability: 500,000pcs/day
Get Best Price Contact Now
Detail Information
Sample: Whole Blood/Plasma Type: Cassette
Certificate: ISO, CE Origin: China
Shelf Life: 24 Months Usage: Professional Use
Highlight:

CE Certified Rapid Test Kit

,

Plasma Diagnosis Rapid Test Kit

,

Whole Blood Rapid Test Kit

Product Description

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.

 

 

 

 

Tag:

Rapid Test Kit,

POCT,

Rapid Diagnostic Test

Contact Details
Bonnie He

Phone Number : +8613030247038

WhatsApp : +8615267039708

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