D-Dimer Test Assay (chemiluminescence assay)
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- Classification: Biological Diagnostics
- Certification: CE, SGS, ISO13485, RoHS
- Methodology: Chemiluminescence Immunoassay
- Delivery Date: Two Weeks After Payment
- Test Quantity of One Box: 100 Test
- Trademark: NORMAN
- HS Code: 3002100009
- Type: Biochemistry Analyzer
- Group: All People
- Service: International After-Sales
- Reagent Type: Liquid
- Test Platform: Norman Chemiluminescence 411
- Origin: Jiangsu, China (Mainland)
D-DIMER reagent (chemiluminesence assay)
1.Negative exclutionindex of venous thromboembolism;
2.High sensitivity, VTE negative predictive value ≥99%, significantly reduce misdiagnosis rate;
3.One of the earlist D-dimer kits utilizingchemiluminescence methodology, leading the direction of high sensitivity D-dimer test direction.
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.
Following are reference ranges for D-dimer
adultFirst trimesterSecond trimester Third trimester
|First trimester||Second trimester||Third trimester|
|mg/L or µg/mL||< 0.5||0.05 - 0.95||0.32 - 1.29||0.13 -1.7|
|µg/L or ng/mL||< 500||50 - 950||320 - 1290||130 - 1700|
|nmol/L||< 2.7||0.3 - 5.2||1.8 - 7.1||0.7 - 9.3|
Indications of D-Dimer
D-dimer testing is of clinical use when there is a suspicion of deep venousthrombosis (DVT), pulmonary embolism(PE) or disseminated intravascular coagulation (DIC).It is under investigation in the diagnosis of aortic dissection.
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.
ICU, outpatient emergency, surgery, Department of respiration, Department of
Cardiology, Internal Medicine-Neurology,Geriatric department, oncology, gynecology.
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).
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.
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