MRX D-Dimer

Latex-based liquid components for quantifying D-dimer fragments in human citrated plasma using readers with wavelengths 350-900nm.

Medirox D-Dimer series is developed for unified D-dimer reporting across multiple systems. Each reagent in the series utilizes the same monoclonal antibody, but is suitable for different systems, ensuring a coverage of most measuring systems. The reagent series is composed of three different assays, MRX143 made to work on measuring systems using red light, and two different reagents MRX147 and MRX 147B for blue light. MRX147 is designed to work on semi- and fully automated instruments with short beam paths, whereas MRX147B is designed to work on the classic instruments having a wider beam path. 

 

Latex based assay

Liquid components, ready to use

Adoptable to most 350-900 nm measuring systems

Excellent correlation between 405 nm / 660 nm / 800 nm methods

High sensitivity, low cut-off value (200 ng/mL) for a high exclusion
rate of DVT and PE

 

General Description

D-dimer is a key indicator of thrombotic events such as deep venous thrombosis (DVT), pulmonary embolism (PE) and disseminated intravascular coagulation (DIC). MRX D-Dimer is used to exclude a diagnosis of DVT or PE and to monitor therapy in DIC.

 

Performance Characteristics

The reaction is obtained through latex particles coated with a monoclonal antibody directed against D-dimer. In the presence of D-dimer the latex particles will aggregate and an optical change can be measured. An obstacle in standardising D-dimer reporting has been that manufacturers of instrument have developed reagents based on a unique series of monoclonal antibodies. 

This has led to a variation in results between systems, and besides the risk of confusion regarding patient results it complicates all forms of external control programs. MediRox series of D-Dimer is unique to share one monoclonal antibody for all reagents. With the same antibody MRX143 and MRX147/147B can be used on most reading devices, and can be jointly calibrated.

Sensitivity & specificity

Details & typical data, MRX147/147B

Product form: Liquid components
Available volumes: • MRX147 kit: 3 mL latex + 7 mL reaction buffer
• MRX147B kit: 6 mL latex diluted + 7 mL reaction buffer
• MRX143 kit: 4 mL latex + 7 mL reaction buffer
• Other filling volumes upon request
Origin: Monoclonal antibodies
Additional products needed: • Eximius Control Basic or Plus (L1/L2/L3) (MRX170-MRX173, MRX180-MRX183)
• Scandinavian Controls Multi and Multi Plus (GHI162/GHI167B, GHI164/GHI170)
• D-Dimer Calibrator (MRX144) or Multi Calibrator I (MRX1202)
• Sample Diluent (0,9 % NaCl) for calibrator dilutions (MRX184)

Parameters: MRX147, MRX147B MRX143
Wavelength: 400-600 nm 600-800 nm
Sensitivity: 99% NPV using 200 ng/mL cut off 98% NPV using 200 ng/mL cut off
Hook effect: No Hook effect <100 000 ng/mL No Hook effect <130 000 ng/mL
Dynamic range: 41,3 - 1000 000 pg/mL 41,3 - 1000 000 pg/mL
Specificity: >100-fold specificity for D-dimer (Fibrin or purified D-dimer), over Fibrinogen, Fibrinogen D or Fragment E >100-fold specificity for D-dimer (Fibrin or purified D-dimer), over Fibrinogen, Fibrinogen D or Fragment E
Interfering substances: No interferences with UF and LMW Heparin <100 U/mL Bilirubin < 0,1 g/L Triglycerides <2,5 g/L Hemoglobin <4 g/L No interferences with UF and LMW Heparin <100 U/mL Bilirubin <0,5 g/L Triglycrides <20 g/L Hemoglobin <10 g/L

Stability & storage

Storage: 2-8 °C
Shelf-life: 18 months at 2-8 °C
Open vial stability: 4 weeks at 2-25 °C

Ordering information

Reference number Product description Pack size
MRX147 MRX D-Dimer (latex + reaction buffer) 5x3 mL + 5x7 mL
MRX147B MRX D-Dimer (latex diluted + reaction buffer) 5x6 mL + 5x7 mL
MRX143 MRX D-Dimer (latex + reaction buffer) 5x4 mL + 5x7 mL
MRX170 Eximius Control Basic, L1+L2+L3 4+4+2x1 mL
MRX171/172/173 Eximius Control Basic, L1/L2/L3 10x1 mL pack per level
MRX180 Eximius Control Plus, L1+L2+L3 4+4+2x1 mL
MRX181/182/183 Eximius Control Plus, L1/L2/L3 10x1 mL pack per level
GHI162/167B Scandinavian Control Multi, L1/L2 10x1 mL pack per level
GHI164/170 Scandinavian Control Multi Plus, L1/L2 10x1 mL pack per level
MRX144 D-Dimer Calibrator 1x1 mL
MRX1202 Multi Calibrator I (AT, fibrinogen, D-dimer) 1x1 mL
MRX184 Sample Diluent (0,9 % NaCl) 10x8 mL

MRX D-Dimer product line

Item & description
Pack size

MRX143

600-800 nm D-Dimer Kit

5x4 mL Latex
5x7 mL Reaction Buffer

MRX147B

400-600 nm D-Dimer Kit, pre-diluted

5x6 mL Latex
5x7 mL Reaction Buffer

MRX147

400-600 nm D-Dimer Kit, conc

5x3 mL Latex
5x7 mL Reaction Buffer

MRX171

Eximius Control Basic L1

10x1 mL

MRX172

Eximius Control Basic L2

10x1 mL

MRX173

Eximius Control Basic L3

10x1 mL

MRX181

Eximius Control PLUS L1

10x1 mL

MRX182

Eximius Control PLUS L2

10x1 mL

MRX183

Eximius Control PLUS L3

10x1 mL

MRX144

D-Dimer Calibrator for calibration of MRX D-Dimer assays (MRX147B/MRX147/MRX143), suitable for instrument readers with wavelengths of 400-600 nm or 600-800 nm. 

1x1 mL

MRX1202

Multi Calibrator I (AT, Fib, DD) intended for calibration of AT, Fib Clauss and D-Dimer assays.

1x1 mL (MRX1202)

10x1 mL (MRX1202-10)

 
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