Description
Product Specifications
COA
IFU
Instrument
Description
D-Dimer is a fibrin degradation product, a small protein fragment present in the blood after a blood clot is degraded by fibrinolysis. It is so named because it contains two D fragments of the fibrin protein joined by a cross-link, hence forming a protein dimer. D-Dimer levels are used as a predictive biomarker for the blood disorder, disseminated intravascular coagulation and in the coagulation, disorders associated with COVID-19 infection. A four-fold increase in the protein is an indicator of poor prognosis in people hospitalized with COVID-19. Determination of D-Dimer is used for diagnosis of deep vein thrombosis (DVT), pulmonary embolism (PE), disseminated intravascular coagulation (DIC) and stroke.
Product Specifications
Intended Use
D-Dimer Assay Kit is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of D-Dimer in human plasma. The assay kit is intended for in vitro diagnostic use.
Principle
The D-Dimer assay is a quantitative sandwich immunoassay to determine the presence of D-Dimer in human plasma and plasma using CMIA technology with flexible assay protocols.
- Sample, assay diluent, paramagnetic anti-D-Dimer coated microparticles and a conjugate containing acridinium-labeled anti-D-Dimer are mixed, D-Dimer present in the sample binds to anti-D-Dimer coated microparticles and acridinium-labeled anti-D-Dimer, forming an antigen antibody complex.
- After further incubation and washing, Pre-Trigger and Trigger Solutions are added to the reaction mixture.
- The resulting chemiluminescent reaction is measured as relative light units (RLUs). There is a relationship between the amount of D-Dimer in the sample and the RLUs detected by the optical system. Results are calculated automatically based on the previously established calibration curve.
Storage
The kit should be stored upright, not upside down or horizontally. Store at 2–8°C with a validity period of 12 months.
COA
IFU
Instrument