Intended Use
D-Dimer iClia is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of D-Dimer in human plasma as an aid in the diagnosis of exclude venous thrombosis, auxiliary diagnosis of disseminated intravascular coagulation and monitoring of thrombolytic therapy in conjunction with other laboratory and clinical findings. The assay kit is intended for in vitro diagnostic use.
Salient Features
• Based on Sandwich chemiluminescent microparticle immunoassay
• Acridinium Ester (AE) based kit for more accurate results
• Test result obtained at 20 minutes
• Analytical Sensitivity: 200 ng/ml
• Linearity: 200 ng/ml to 20000ng/ml
• Long shelf life: 12 months at 2-8oC
• Onboard stability of reagents: 30 days at 2-8oC
• Convenient pack size: 50 Tests
• Prompt service back-up
Principle
D-Dimer iClia is chemiluminescent immunoassay based on the “Sandwich” principle. The magnetic microparticles are coated with Anti- D-Dimer antibodies. In the first step, anti-D-Dimer IgG labeled magnetic microparticle, human plasma, Assay buffer and an anti-D-Dimer IgG labeled acridinium ester conjugate are mixed and incubated in an assay cup, which allows patient specific D-Dimer to bind to microparticle. After sample matrix is removed by washing, the Microparticle-anti-D-Dimer antibody/antigen/antibody immune complex is kept with the help of a magnetic separator. Excess acridinium ester conjugate is removed by washing and finally the bound acridinium ester is detected by addition of chemiluminescent substrate. The relative light unit (RLU) intensity is proportional to the amount of D-Dimer. According to the D-Dimer RLU-concentration standard curve, the RLU tested can be interpreted to D- Dimer concentration in the sample expressed as ng/mL.
