i-CHROMA D-Dimer

i-CHROMA D-Dimer

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Summary

D-dimer, a degradation product of cross-linked fibrin formed during activation of the coagulation system, is commonly used to excludethromboembolic disease in outpatients suspected of having deep venous thrombosis (DVT) and pulmonaryembolism (PE). DVT and PE are relatively common and can cause sudden, fatal embolic events in the pulmonary arteries and other regions. Measurement of the D-Dimer level in plasma has been used as a screening strategyfor subclinical DVT. D-Dimer is well known to be an importantprognostic indicator of heart diseases its most definitive role is onmonitoring post-treatment clinical status and the post therapeutic evaluation of patients.

Overview
Test Principle
ichroma™ D-Dimer Test is based on fluorescence immunoassay technology. ichroma™ D-Dimer uses a sandwich immunodetection method, such that by mixing detector buffer with blood specimen in test vial, the fluorescence-labeled detector anti-D-Dimer antibody in buffer binds to D-Dimer antigen in blood specimen. The sample mixture is loaded and migrates on the matrix of test cartridge; the complexes of detector antibody and D-Dimer are captured to anti- D-Dimer sandwich pair antibody that has been immobilized on test matrix.
Test Duration
Test takes approx. 12 minutes
Analytical Range
50~10,00 ng/mL

Specification

• Sample Type : Plasma/Serum

• Precision
CV < 10%
• Linearity: 50~10,000 ng/mL (R=0.998)