D-Dimer test Rapid Test poct Kits

              D-Dimer test Rapid Test poct Kits 

Methodology                                                                                 

Fluorescence  Immunoassay

Product Name                                                                              

General Name:D-Dimer Test Kit(Immunofluorescence)

Package                                                                                           

Test card: Aluminum foil pouch 1pc/bag, desiccant

Package size: 25pcs/box

Size in detailed:15.5CM x 16.5CM x7.5CM

Intended use                                                                                

The test kit is primarily for the in vitro quantitative determination of D-Dimer content in 

human blood plasma.

D-Dimer is a good index for diagnosing activity fibrinolysis. It has significant diagnosis 

value for thrombosis diseases such as DIC, deep venous thrombosis, cerebrovascular 

disease, pulmonary embolism, hepatic disease, after surgery, AMI, gynecology and 

pediatrics diseases, meanwhile it can be used in detecting the thrombolytic therapy.

Principle of the Procedure                                                     

The reagent is based on immunefluorescence sandwich assay to detect D-Dimer 

concentrations quantitatively. Using the pipette provided, drop diluted sample into the 

sample well. During testing, specimen reacts with the particles coated with anti-D-Dimer 

monoclonal antibody I which has conjugated with fluorescent latex. The mixture migrates 

upward on the nitrocellulose membrane by capillary action to react with anti-D-Dimer 

monoclonal antibody II on the test line. The intensity of fluorescent antibody signal reflects

 the amount of captured D-Dimer. Immunefluorescence quantitative analyzer produced by 

our company can detect the concentration of D-Dimer in the sample.

Main components                                                                      

1. Test kit contains: 25 test cards and an IC card

The test card is composed of plastic shell and test strip.

The main components of test strip: Sample pad, bonding pad, nitrocellulose membrane, 

Anti-MIgG, absorbent paper, PVC base plate.

2. Diluents (3ml×1 bottle): composed of phosphat , etc. PH=7.4±0.2.

Materials required (but not provided):

1.Timer

2.Centrifuge tube

3.Pipette

4.Disposable tips

Storage And Stability                                                                

The reagent box must be stored from 4 to 30℃, and the period of validity is 12 months. 

The reagent strip must be used within 1 hour once its foil pouch has been opened. Do not

use the strip beyond the expiration date printed on the outside of the box. 

Warnings And Precautions                                                    

This in vitro diagnostic reagents is disposable product, please do not re-use, do not use 

expired products.

1.In the collection, processing, storage, mixing and sample testing process should take 

   appropriate protective measures.

2.Please do not use the product which has been opened, do not use obvious damaged test

    kit or detection card.

3.Different batches of reagents can not be mixed, IC card and the detection card are the 

    same.

4.The detection card and its components are only applicable to the series of 

    immunofluorescent analyzer in NORMAN.

5.The test must follow the steps indicated by the operation, improper operation will lead 

    to erroneous results.

6.Do not insert detection card which has wetted the surface by liquid into the analyzer, in 

    order to prevent damaging to the instrument. Please properly dispose the used 

    detection card, do not throw it away.

7.Suitable ambient temperature was good for the test, do not keep the temperature too 

    high or too low. Cryopreserved detection card needs to be restored to room temperature 

    before opening, in order to avoid moisture absorption.

8.The detection card and quantitative immunofluorescence analyzer should keep away 

    flutter and electromagnetic environment when be used. The instrument itself fibrillation 

    is normal, did not pull out the IC card when it was detected.

9.Fresh samples were recommended, if the samples which have significant hemolysis or 

    blood clots should be abandoned, all patient samples should be treated as a potential    

    source of infection.

10.The date of manufacture and expiry date were on the label.

Clinical Significance                                                                  

Deep vein thrombosis (DVI) and exclusion diagnosis of pulmonary embolism(PE).

Diagnosis of disseminated intravascular coagulation(DIC).

Effective detection and evaluation indicator of thrombolytic effect.

Condition evaluation of cardiovascular disease.

Identification and treatment detection of cerebral infarction.

Package & Delivery                                                                    

About us                                                                                         

Certifications                                                                                

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If you are interested in working with us, please feel free to contact.