Instrumentation Laboratory Launches HemosIL® FDP Assay in Europe, Asia and Other International Regions
Augments Fully Automated Assay Menu for the Detection of Fibrinolytic Disorders
BEDFORD, Mass.– Instrumentation Laboratory (IL) today announced the release of the HemosIL FDP assay as a European CE IVD Mark product under the European Directive on in vitro Diagnostic Medical Devices. The assay will be commercialized in countries throughout Europe, Asia, and other international markets. FDP is an immunoturbidimetric assay designed for the detection of Fibrinogen Degradation Products (FDP) on the fully automated ACL TOP® Family of Hemostasis Testing Systems.
HemosIL FDP offers significant improvements over traditional manual and qualitative methods through full automation and quantitative detection to achieve enhanced accuracy and efficiency. Its liquid, ready-to-use formulation minimizes waste and hands-on prep time. Innovative assay technology offers reduced fibrinogen interference and an extended measurement range for superior analytical performance. Optimized for use on the ACL TOP® Family of Hemostasis Testing Systems, HemosIL FDP provides results in less than 7 minutes and is available on-demand, 24 hours/day, 7 days/week.
"Many FDP reagents are manual and rely on qualitative interpretation, leading to error and delays in treatment. The HemosIL FDP assay eliminates these obstacles, adding enhanced quantitative detection, broad linearity range, and allows an entire fibrinolytic work-up from the same citrated plasma sample," said Remo Tazzi, Director, Hemostasis Marketing at IL. "This new assay exemplifies our commitment to providing innovative solutions for greater efficiency and analytical excellence."
Elevated FDP levels are observed in patients with Venous Thromboembolism (VTE) and Disseminated Intravascular Coagulation (DIC). Therefore, FDP is an important marker for evaluating fibrinolytic disorders, diagnosing thrombosis and monitoring thrombolytic treatment. HemosIL FDP adds to IL's robust portfolio of fibrinolysis testing solutions for VTE and DIC.
HemosIL FDP assay is an automated, latex-enhanced immunoturbidimetric assay for the quantitative determination of FDP in human citrated plasma. It features latex particles coated with monoclonal antibodies highly specific to fragment D included in fibrin/fibrinogen-soluble derivatives. When plasma containing FDP is mixed with the reagent and reaction buffer, coated particles agglutinate. The degree of agglutination is directly proportional to the FDP concentration in the sample, and is determined by measuring the decrease in transmitted light at 671 nm caused by the aggregates.(4)
About Fibrin Degradation Products (FDP)
FDP are fragments produced by the action of plasmin on deposited fibrinogen, fibrin monomers, and unstable or stable fibrin, during clot degeneration. FDPs are generated before clot formation, via fibrinogenolysis, and after clot formation, via fibrinolysis. D-Dimer is a type of FDP that is generated when plasmin degrades a stabilized fibrin clot. In addition to being used as a marker for monitoring fibrinolytic disorders,(1,2) FDP tests are performed in conjunction with D-Dimer tests to enhance clinical information on the status of these conditions. Abnormal FDP levels may be observed in myocardial infarction, stroke, post-operative state, liver disease, obstetric disorders, and malignant tumors.(3)
HemosIL FDP Assay is not currently 510(k) cleared.
1 Palareti G. Fibrinogen/fibrin degradation products: Pathophysiology and clinical application. Fibrinolysis. 1993; 7:60-61.
2 Gaffney PJ. The occurrence and clinical relevance of fibrin fragments in blood. Annals New York Academy of Sciences. 1983, 408: 407-423.
3 Kotte-Marchant K. An algorithmic approach to hemostasis testing. CAP. 2008.
4 Newman DJ, et al. Particle enhanced light scattering immunoassay, Ann Clin Biochem. 1992;29:22-42.
Instrumentation Laboratory (www.ilus.com), founded in 1959, is a worldwide developer, manufacturer and distributor of in vitro diagnostic instruments, related reagents and controls for use primarily in hospitals and independent clinical laboratories. The company's product lines include critical care systems, hemostasis systems and information management systems. IL's GEM(® )product offerings, part of the critical care line, include the GEM Premier™ 4000 analyzer with Intelligent Quality Management (iQM(®)), GEM Premier 3500, GEMweb(®) Plus Custom Connectivity, and the GEM PCL Plus, a portable coagulation analyzer. IL's hemostasis portfolio includes the ACL TOP(®) Family of Hemostasis Testing Systems, fully automated, high-productivity analyzers, including the ACL TOP 700, ACL TOP 700 LAS, ACL TOP 500 CTS and the new ACL TOP 300 CTS. IL also offers the new ACL AcuStar(®), ACL ELITE(®) and ELITE PRO, other hemostasis analyzers and the HemosIL(®) line of assays. IL is based in Bedford, Massachusetts.
CONTACT: Sally McCraven, Instrumentation Laboratory,
Web Site: http://www.ilus.com