D-DIMER reagent (chemiluminesence assay)

Methodology                                                                                 

chemiluminesence immunoassay(CLIA)

D-Dimer                                                                                          

Negative exclutionindex of venous thromboembolism

High sensitivity, VTE negative predictive value ≥99%, significantly reduce misdiagnosis rate.

One of the earlist D-dimer kits utilizingchemiluminescence methodology, leading the 

direction of high sensitivity D-dimer test direction.

D-Dimer  Definition                                                                   

D-dimer (or D dimer) is a fibrin degradation product (or FDP), a small protein fragment 

present in the blood after a blood clot is degraded by fibrinolysis. It is so named because 

it contains two crosslinked D fragments of the fibrin protein.

D-dimer concentration may be determined by a blood test to help diagnose thrombosis. 

Since its introduction in the 1990s, it has become an important test performed in patients

with suspected thrombotic disorders. While a negative result practically rules out 

thrombosis, a positive result can indicate thrombosis but does not rule out other potential 

causes. Its main use, therefore, is to exclude thromboembolic disease where the probability 

is low. 

In addition, it is used in the diagnosis of the blood disorder disseminated  intravascular 

coagulation.

Principles of  D-Dimer                                                              

Coagulation, the formation of a blood clot or thrombus, occurs when the proteins of 

the coagulation cascade are activated, either by contact with damaged blood vessel 

wall and exposure to collagen in the tissue space (extrinsic pathway) or by activation 

of factor VII by tissue activating factors (intrinsic pathway). Both pathways lead to 

the generation of thrombin, an enzyme that turns the soluble blood protein fibrinogen

into fibrin, which aggregates into proteofibrils. Another thrombin-generated enzyme,

factor XIII, then crosslinks the fibrin proteofibrils at the D fragment site, leading to 

the  formation of an insoluble gel which serves as a scaffold for blood clot formation.

D-dimers are not normally present in human blood plasma, except when the coagulation 

system has been activated, for instance because of the presence 

of thrombosis or disseminated intravascular coagulation. The D-dimer assay depends 

on the binding of a monoclonal antibody to a particular epitope on the D-dimer fragment. 

Several detection kits are commercially available; all of them rely on a different monoclonal

antibody against D-dimer. For some of these, the area of the D-dimer to which the

antibody binds is known. The binding of the antibody is then measured quantitatively by

one of various laboratory methods.

For DVT and PE, there are possible various scoring systems that are used to determine 

the a priori clinical probability of these diseases; the best-known is the Wells score.

Interpretation                                                                             

Reference ranges

Following are reference ranges for D-dimer

UnitsNonpregnant

adultFirst trimesterSecond trimester Third trimester

Indications of D-Dimer                                                            

D-dimer testing is of clinical use when there is a suspicion of deep venous

thrombosis (DVT), pulmonary embolism(PE) or disseminated intravascular 

coagulation (DIC).It is under investigation in the diagnosis of aortic dissection.

Clinical Significance                                                                  

Deep vein thrombosis (DVI) and exclusion diagnosisof 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.

Applicable Department                                                           

ICU, outpatient emergency, surgery, Department of respiration, Department of 

Cardiology, Internal Medicine-Neurology,Geriatric department, oncology, gynecology.

Product Advantage                                                                    

1.High sensitivity:50ng/ml

2.High accuracy:99% result correlation with Siemens INNOVANCE D-dimer

3.Wide linear range: 50-10000ng/ml(FEU)

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

European society of Cardiology

Guidelines for the diagnosis and treatment of acute pulmonary embolism

Recommend to use D-dimer testing as the screening indicator of pulmonary 

embolismdiagnosis in emergency department

Clinical and laboratory standards institute

H59-P guideline: In low and middle clinical risk peak, D-dimer quantitive testing is used 

for excluding diagnosis of Venous Thrombus Embolism(VET).

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About us                                                                                         

Powered by advanced technology and excellent talents in the IVD field, Norman has been 

consistently improving its innovation platform , and increasing R&D investment. Self-

innovation, combined with long-term strategic cooperation with universities and research

institutes and with outsourced technologies, ensures consistent improvement on product

quality. Norman's R&D field has covered instruments, reagents, and raw materials, and 

has  been entrusted by the Nanjing government to build a R&D center specialized in 

biological chemistry and immunity diagnosis. Up to now, Norman has acquired over 20 

patents.

Being an expert in automated chemiluminescence analysis , Norman owns independent and 

completed intellectual property rights, and its products provide top-notch sensitivity, 

precision and accuracy . Thanks to the self-developed antigens and self-manufactured 

antibodies, Norman's products features minimized intra-and inter- batch difference.

After 8 years development, Norman is now on the fast track. An over 30,000m2 global 

R&D center is in construction, and will hold more than 1,000 R&D engineers in the future.

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