D-Dimer FS

D-Dimer FS

D-Dimer FS

Product catalog summary
Overview: This document provides detailed information about the D-Dimer FS test, a diagnostic tool used to exclude thrombosis, developed by DiaSys Diagnostic Systems GmbH. It highlights the test's clinical relevance, performance characteristics, and the company's commitment to quality and sustainability.
Clinical Relevance: The D-Dimer FS test detects fibrin degradation products, specifically D-dimer, which are indicative of thrombin activity and fibrin formation. Elevated D-dimer levels suggest venous thrombotic events (VTE) but can also be elevated in conditions like cancer or infections. The test is particularly useful for excluding deep vein thrombosis (DVT) and pulmonary embolism (PE) due to its high negative predictive value (NPV).
Diagnostic Value: The test is used to screen individuals with symptoms of thromboembolic events. A D-dimer level below 0.5 µg FEU/mL effectively rules out DVT, while levels above this threshold require further diagnostic imaging. The D-Dimer FS reagent shows a diagnostic sensitivity of 98% and specificity of 80.5% for DVT, meeting CLSI standards.
Test Characteristics: The D-Dimer FS is a ready-to-use, two-component reagent with a wide measuring range up to 8.7 µg FEU/mL and high prozone security up to 50 µg FEU/mL. It offers excellent precision and stability, suitable for various clinical chemistry analyzers.
Precision: The test demonstrates high precision with low coefficients of variation (CV) across different sample levels, ensuring reliable results.
Company Commitment: DiaSys emphasizes over 25 years of experience in clinical chemistry, offering high-quality, German-made products. Their processes are ISO 13485 certified, ensuring top quality and environmental sustainability.
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Catalog excerpts

D-Dimer FS-1

Leading Technology in Fluid-stable Reagents from DiaSys · · · · · · · · Emergency Test for Exclusion of Thrombosis Over 25 years of experience in development and production of clinical chemistry tests Premium service in technics, applications and after sales Quality products made in Germany High performance, ready-to-use reagents with minimized interferences, long shelf life and on-board stability as well as traceability to international references Perfectly matched fluid-stable reagents, calibrators and controls High grade raw materials from traceable origin Processes and resources certified according to ISO 13485, fulfilling highest quality standards Sustainable processes and products preserve the environment DiaSys Diagnostic Systems GmbH Alte Strasse 9 65558 Holzheim Germany Climate neutral print (Carbon neutral) ID: DE-626-212177 Printed on FSC certified paper Sensitive. Stable. Secure. Diagnostic Sensitivity Meets Perfo

 Open the catalog to page 1
D-Dimer FS-2

Performance Characteristics Clinical Relevance Sensitivity 98% Specificity 80.5% Cut-off 0.5 µg FEU/ml Elevated D-Dimer Sensitivity The fibrin degradation product, D-dimer is detectable after plasmin degradation of cross-linked fibrin. Elevated D-dimer values indicate increased thrombin activity and fibrin formation and are therefore an indirect marker of venous thrombotic events (VTE). D-dimer values are increased in various conditions, such as cancer, liver cirrhosis or infections, which make a reliable diagnosis of a thrombotic event difficult. However, D-dimer results have a high negative...

 Open the catalog to page 2
D-Dimer FS-3

Performance Characteristics Clinical Relevance Sensitivity 98% Specificity 80.5% Cut-off 0.5 µg FEU/ml Elevated D-Dimer Sensitivity The fibrin degradation product, D-dimer is detectable after plasmin degradation of cross-linked fibrin. Elevated D-dimer values indicate increased thrombin activity and fibrin formation and are therefore an indirect marker of venous thrombotic events (VTE). D-dimer values are increased in various conditions, such as cancer, liver cirrhosis or infections, which make a reliable diagnosis of a thrombotic event difficult. However, D-dimer results have a high negative...

 Open the catalog to page 3
D-Dimer FS-4

Leading Technology in Fluid-stable Reagents from DiaSys · · · · · · · · Emergency Test for Exclusion of Thrombosis Over 25 years of experience in development and production of clinical chemistry tests Premium service in technics, applications and after sales Quality products made in Germany High performance, ready-to-use reagents with minimized interferences, long shelf life and on-board stability as well as traceability to international references Perfectly matched fluid-stable reagents, calibrators and controls High grade raw materials from traceable origin Processes and resources certified...

 Open the catalog to page 4

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*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.