Cardiac D-Dimer Rapid Test Kits for Fluorescence Immunoassay

Quick read D-Dimer test kits：

Methodology： Fluorescence  Immunoassay

D-Dimer：                                                                                         

1. Negative exclusion indicator of venous thromboembolism.

2. High sensitivity, VTE negative predictive value ≥99%.

3. D-dimer is a product of fibrin clot digestion and therefore is an indicator of recent or

    current clot formation and lysis. 

4. It is the most frequently used marker of coagulation and fibrinolysis.

Clinical Utility Of  The D-dimer Assay：                               

1. The utility of the assay lies in its negative predictive value since a high D-dimer is a 

non-specific finding. A negative result (D-dimer concentration below the cut-off) can 

be used to assist in the exclusion of VTE in certain patient populations.

2. D-dimer testing is often utilized in a diagnostic algorithm which combines clinical decision 

rules and imaging studies. If the clinical decision rule categorizes a patient as low or unlikely

to have VTE and the patient has a negative D-dimer test (using a sensitive assay), then the 

diagnosis is excluded.

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.

Applicable department：                                                           

ICU, outpatient emergency, surgery, respiration, cardiology, internal medicine-

neurology, geriatric, oncology, gynecology.

Product Advantage：                                                                    

1. High sensitivity:0.1mg/l.

2. Convenient use: test card is aluminum foil bag for 1 person per bag, test  immediately

    when patient comes.

3. Small sample size: 30ul (plasma).

4. High accuracy: 99% correlation with Siemens D-Dimer.

5. Wide linear range:0.1-10mg/l.

Performance Analysis：                                                              

1. Correlation analysis between Norman D-Dimer and Siemens D-Dimer European society of Cardiology

Guidelines for the diagnosis and treatment of acute pulmonary embolism.

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

diagnosis in emergency department.

3. Clinical and laboratory standards institute.

4. 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 mainly for the in vitro quantitative determination of D-Dimer in human plasma. 

D-Dimer is a good index of active cellulose dissolution. It is of diagnosis value in diseases 

caused by thrombosis such as disseminated intravascular coagulation (DIC), deep vein thrombosis,

 pulmonary embolism, cerebrovascular disease, liver disease, acute myocardial infarction after the surgery, 

gynecology, pediatrics and other diseases. At the same time, D-Dimer detection can also be used as an index 

in the treatment of thrombolytic drug.

Test Principle

The reagent is based on immunofluorescence sandwich assay to detect D-Dimer concentrations quantitatively. 

Add the sample to the sample well of the cartridge. Through chromatography sample reacts with the fluorescent

 latex particles coated with D-Dimer monoclonal antibody I on the conjugate pad. The complex spread ahead 

along the nitrocellulose membrane captured by D-Dimer monoclonal antibody II on the test line.The more 

D-Dimer the sample contains, the more complexes the test line accumulates. The intensity of fluorescent 

antibody signal reflects the amount of captured D-Dimer. Immunofluorescence quantitative analyzer produced

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

Related products

Package & Delivery：                                                                    

Inflammation/Infection： PCT(whole blood), PCT (surum),  hs-CRP

Cardiovascular： NT-proBNP, D-Dimer cTnI,CK-MB, MYO

Nephropathy： NAGL, RBP,Cys-c, mAlb, B2-MG

Gastrosis： PGⅠ/ PGⅡ/ PGR/ HP/ FOB

Rheumatism：RF

Diabetes：C-Peptide

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.

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.

R&D shapes future, and concentration determines success. Driven by the commitment to

"provide complete solution to improve human health", Norman will consistently do its

utmost to drive the IVD industry forward and contribute more to human health.

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