D-Dimer one step test kits with 

                             CE china supplier

D-Dimer                                                                                          

Negative exclusion indicator of venous thromboembolism
High sensitivity, VTE negative predictive value ≥99%.

Methodology                                                                                 

Fluorescence  Immunoassay

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).

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.

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.

Package & Delivery                                                                    

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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.

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