D-Dimer  test rapid  test assay

                                       For D-Dimer

Methodology                                                                                 

Fluorescence  Immunoassay

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Package                                                                                           

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

Package size: 25pcs/box

Size in detailed:15.5CMx16.5CMx8.1CM

                           25PCSx30BOXES/CARTON

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):

    Timer

    Centrifuge tube

    Pipette

    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. 

Specimen Collection And Preparation                              

1.The blood plasma specimen is suggested to use 1: 9 Na-Citrate blood collection tube for  

    collecting and the specimen is suggested to be tested within 4hours.

2.The specimens must be returned to room temperature before testing.

Interpretation Of  Test Results                                             

1.The analysis of test results are accomplished by  immune-fluorescence  quantitative 

    analyzer of  our company's NORMAN series.

2.The concentration of D-Dimer in the unknown samples can be read directly in the

    corresponding batch of ID card standard curve by fluorescence signal value we 

    measured. The default results use mg/L as a unit.

Expected values/Reference range                                       

The reference range study was conducted based on D-Dimer content of 95% of the 

distribution range of statistical analysis in 120 healthy people, the result was as follows:

Normal reference values: ≤ 0.5 mg/L

It is recommended that each laboratory established its own reference range, which may be

unique to the population it serves depending upon geographical, patient, dietary, or 

environmental factors.

D-Dimer                                                                                          

Negative exclusion indicator of venous thromboembolism.

High sensitivity, VTE negative predictive value ≥99%.

D-Dimer plasma specs                                                              

Clinical Significance                                                                  

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

2.Diagnosis of disseminated intravascular coagulation(DIC).

3.Effective detection and evaluation indicator of thrombolytic effect.

4.Condition evaluation of cardiovascular disease.

5.Identification and treatment detection of cerebral infarction.

Performance Analysis                                                               

Correlation analysis between Norman D-Dimer and Siemens D-Dimer.

European society of Cardiology

Guidelines for the diagnosis and treatment of acute pulmonary embolism

Recommend to use D-Dimer test as the screening indicator of pulmonary embolism

diagnosis in emergency department

Clinical and laboratory standards institute

H59-P guideline: In low and middle clinical risk peak, D-Dimer quantitative test is used 

for exclusion diagnosis of venous thrombus embolism(VET).

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About us                                                                                         

Nanjing Norman Biological Technology Co., Ltd is dedicated to R&D and manufacturing of 

automated chemiluminescence system. Founded in 2008, Norman biological has been 

upholding the idea that R&D shapes future ,and concentration determines success. Ever

since the beginning, Norman has been focusing on developing and manufacturing 

chemiluminescence instruments and reagents.

Norman's manufacture center is located in the Yuhua District and owns an over 2,000m2 

GMP-approved clean workshop. The R&D base, which is over 2,000m2 , is located in state-

level new Jiangbei district. Now there are over 100 R&D engineers, 40% of which hold a

PhD or master's degree.

Certifications                                                                                

Agent Wanted                                                                              

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