Pdf package insert for d-dimer

Hemosil reagents instrumentation laboratory worldwide. This approach can reduce the need for costly and invasive imaging tests, typical in the diagnosis of vte. The ddimer assay on the stratus cs analyzer is an in vitro diagnostic test for the quantitative measurement of crosslinked fibrin degradation products ddimer in human citrated or heparinized plasma. The innovance ddimer is substantially equivalent to the vidas ddimer exclusiontm k040882 assay. The d dimer values are presented in units of mass ngml of d dimer, also known as d dimer units d du. There are no international standards for ddimer and different assays use antibodies with differing specificities for ddimer and other fibrin degradation products. Qdl97000bd bonus pack 25 x 3, 1 kit of each test triage cardiac panelbnp, d dimer combo 3 kits, 25 tests per kit one of bnp. The innovance ddimer method, like the vidas ddimer exclusiontm method, is intended for use in conjunction with a clinical pretest probability ptp assessment model to exclude pulmonary embolism pe disease. Nanopia pfdp blood coagulation diagnostics business. Sampling center sample and all axsym d dimer reagents required for one test are pipetted by the sampling probe into various wells of a reaction vessel rv. Staliatest ddi plus, less interferences for even more confidence back to list as part of stagos continuous improvement commitment, sta liatest ddi plus was developed as an evolution of the sta liatest ddi, one of the most published ddimer assays, also fda approved for aid in the diagnosis of venous thromboembolism vte.

Reagent preparation manual test procedure allow all vials to. Reagents that require calibration are described in the reagent package insert. Please contact your beckman coulter account representative for more information. Disseminated intravascular coagulation dic in dic the fibrinolytic system is activated and therefore the ddimer level increases. Coagulopathy both ddimer and fibrinogen must apply ddimer from day 6 onwards increase to 6 mgkg reference id. Target level ddimer ngml feu level low 250 level 1 550 level 2 1600 level 3 3200 the values listed are approximate targets. Ddimer assays can help in the diagnosis of dic, and in dic patients management 5, 8, 14, 18. From june 2011, this document is the only relevant source for assay application information on the sysmex ca500 series system. D dimer is a specific marker of degradation of fibrin clot and an indirect marker of clot formation. Carry out semiquantitative detection of fibrin and fibrinogen degradation products in human serum and urine using thermo scientific thrombowellcotest rapid latex agglutination test.

Stago detail staliatest ddi plus, less interferences. Ddimer is a coagulation marker that reflects the degree of thrombin turnover. Provide content correction we continue to work to improve your shopping experience and your feedback regarding this content is very important to us. Implementation of a rapid whole blood ddimer test in the emergency department of an urban academic medical center. Alere triage ddimer test product insert pi, english. Pdf evaluation of the innovance ddimer analytical performance. Insert the test device into the test slot of the analyzer. Through this activation, fibrin is degraded by plasmin to various soluble fragments in which the ddimer configuration occurs. The adverse drug reactions reported included headache, pain in the extremities, pain at the injection site, and increase in fibrin d dimer levels without evidence of thromboembolic events. The types of immunoassays available for ddimer measurement include. My name is laura worfolk and i am the scientific and clinical research manager for diagnostica stago. The eurolyser ddimer test allows quick and easy determination of the parameter at the point of care.

Use the reagent code chip module supplied with the new lot of test devices to transfer the data to the meter. During early clot formation, thrombin cleaves fibrinopeptides from the fibrinogen, a soluble plasma protein, converting it into fibrin monomers. The alere triage ddimer test is a fluorescence immunoassay to be used. Refer to figure 1 and the package insert for detail intended use bioway chemistry reagent series ddimer reagent kit the kit is a latexenhanced immunoturbidimetric assay intended for in vitro quantitative detection of ddimer protein in human serum or.

Refer to figure 1 and the package insert for detail intended use bioway chemistry reagent series ddimer reagent kit the kit is a latexenhanced immunoturbidimetric assay intended for in vitro quantitative detection of ddimer protein in human serum or plasma on automated clinical chemistry analyzers. Total fdp is always higher than the ddimer value when using nanopia ddimer. Widely used types and clinical applications of ddimer assay. To share the full product catalog, please use the product catalog download option from the navigation bar at the top of the page. The ddimer assay of the plasmas to be tested is automatically carried out by the. A plasma ddimer test is commonly the first step in patient apte risk assessment, and is considered to have clinical value 15.

The alere triage ddimer test utilizes the 3b6 monoclonal antibody which is highly specific to crosslinked ddimer. Triage ddimer test 7 standardization the quidel triage ddimer test has been standardized using a puri. St1500 indication ddimer test kit ddimer control kit kit size 16 testskit 2 x 1 ml high and low summary. D dimer latex agglutination kit diagnostic reagent for the rapid qualitative or semiquantitative evaluation of circulating derivates of crosslinked fibrin degradation products xlfdp in human plasma t9515707 1 x 2,7 ml d dimer latex 1 x 25 ml d dimer buffer 1 x 0,5 ml positive control 1 x 0,5 ml negative control 5 pcs. Evolution of the ddimer assay in clinical medicine monet n. Please use the form below to provide feedback related to the content on this.

The document library provides customers with a single pointofaccess to technical documents for our entire portfolio of instruments, assays and test kits. Key to symbols used list number calibrator a lot number calibrator b in vitro diagnostic medical device. Ddimer determination is mainly used to exclude deep vein thrombosis of the leg and pulmonary embolism. Package insert instructions must be followed accordingly. This package insert must be read carefully prior to use. Pdf widespread use of ddimer in recent years has led to the development of a number of new fully automated quantitative ddimer assays. Purpose and scope the purpose of this document is to describe the procedure for performing a ddimer. All of the ddimer assays currently available incorporate antibody recognition of and binding to the ddimer molecules. In an exclusion strategy, a ddimer below the established threshold in a. The degree of agglutination is directly proportional to the concentration of ddimer in the sample and is determined by measuring the decrease of transmitted light caused by the aggregates turbidimetric immunoassay. This package insert must be read carefully prior to product use. Stago ddimer for the exclusion of thromboembolism diet.

For frontline healthcare providers, cobas h 232 poc system is a portable pointofcare system that supports optimized treatment of patients with symptoms of chest pain and dyspnea, because it enables confident onthespot diagnosis and assessment of the patients condition based on objective results, comparable with roche laboratory methods, that can be shared. Vidas ddimer exclusion ii is the first test indicated for use to safely exclude a diagnosis of dvt and pe in outpatients with suspected vte, in conjunction with a clinical pretest probability ptp assessment model. The stratus cs ddimer assay is intended for use in conjunction with a nonhigh clinical pretest probability ptp assessment model to. Apr 28, 2017 a plasma ddimer test is commonly the first step in patient apte risk assessment, and is considered to have clinical value 15. The ddimer rapid test cassette whole bloodplasma is a rapid chromatographic immunoassay for the qualitative detection of human d dimer in whole blood or plasma as an aid. Ddimer is a soluble degradation product of crosslinked fibrin under the action of the fibrinolytic system. Learn about the test, when you would need one, and what the results can tell you.

Hemosil ddimer assays are clinically validated with cutoff values for the exclusion of venous thromboembolism vte, including both pulmonary embolism pe and deep vein thrombosis dvt, in conjunction with a pretest probability assessment. Vidas d dimer exclusion ii features d dimer exclusion in a single test. There are no international standards for d dimer and different assays use antibodies with differing specificities for d dimer and other fibrin degradation products. Nycocard ddimer measures ddimer configurated molecules, which are released into the circulation by the activation of the fibrinolysis system. High levels of ddimer are commonly associated with complications in pregnancy. By definition, one feu is the quantity of fibrinogen initially present that leads to the observed level of ddimer. Ddimer methods, informing them of the confusion regarding the type and magnitude of ddimer units and the common practice by laboratories of converting the units.

Roche cobas h 232 ddimer method and sample collection6. Alere triage ddimer test product insert pi, english quidel. Quantitative ddimer assay student health center manuals. Vidas ddimer exclusion iidex2 vidas ddimer exclusion ii is an automated quantitative test for use on the instruments of the vidas family for the immunoenzymatic determination of fibrin degradation products fbdp in human plasma sodium citrate using the elfa technique enzyme linked fluorescent assay. Clinical utility of sta liatest ddimer laura worfolk. Check the expiration date printed on the pouch or package. Proper storage and use of products in compliance with the operator manual package inserts and with diagnostica stago, inc. Alere triage meterpro ddimer method and sample collection10. These products are intended for use in the united states only. Ddimer is elevated in several clinical conditions including dvt, pe and disseminated intra vascular coagulation dic. Ddimer levels are expressed in initial fibrinogen equivalent unitsfeu.

Manual for a complete description of the quality control system. Evaluation of the alere ddimer test for point of care testing article in journal of thrombosis and thrombolysis 382 august 2014 with 623 reads how we measure reads. Alere triage meterpro ddimer method and sample collection iecdd. Clinical application of the innovance ddimer assay in the. It is left to the individual laboratory to define ddimer cut off values for use in the isth scoring system. Eleven single doses of tretten have been administered to nine subjects for pharmacokinetic investigations. Instrumentation laboratory company, bedford, ma 22017. The actual observed values will vary depending upon lot number, analyzer, reagent, method, and calibrator. Blood should be collected in a bluetop tube containing 3. The ddimer values are presented in units of mass ngml of ddimer, also known as ddimer units ddu.

Reliability of assay results cannot be guaranteed if there are any deviations from the instructions in this package insert. Offers 99% npv for all patients even those presenting with medium risk for the most serious condition, pulmonary embolism. Treatment day gamifant dose criteria for dose increase if abnormal at baseline and no improvement fibrinogen mgdl if baseline levels. Evaluation of the alere ddimer test for point of care testing. D dimer is elevated in several clinical conditions including dvt, pe and disseminated intra vascular coagulation dic.

The axsym d dimer reagents and sample are pipetted in the following sequence. Ddimer latex agglutination kit diagnostic reagent for the rapid qualitative or semiquantitative evaluation of circulating derivates of crosslinked fibrin degradation products xlfdp in human plasma t9515707 1 x 2,7 ml ddimer latex 1 x 25 ml ddimer buffer 1 x 0,5 ml positive control 1 x 0,5 ml negative control 5 pcs. Ddimer test has been standardized using a purified. Ddimer is a reliable and sensitive index of fibrin deposition and stabilization. D dimer analyzer aqt90 flex radiometer medical aps, is another sandwich immunoassay that uses tracer and capture antibodies to form d dimer sandwich complexes, which are then measured using timeresolved fluorometry trf, in which the tracer antibody signal is measured directly from the dried assay solution and calibrated to a d dimer. Manufacturers were encouraged to contact their clients to promote the use of only the type and magnitude of ddimer units provided in the package insert. Standard test mode according to the analyzers manual.

D dimer from day 6 onwards increase to 6 mgkg reference id. Ddimer refer to or the package insert of currently available lots for specific analyte and stability claims. Ddimer for exclusion of venous 0918 9311554010gbc this document is not legally binding. Noninvasive diagnosis of venous thromboembolism in outpatients. Ddimer is a specific marker of degradation of fibrin clot and an indirect marker of clot formation. Package insert a rapid test for the qualitative detection of ddimer in whole blood or plasma. The imuclone ddimer elisa is intended for the measurement of ddimer, crosslinked fibrin degradation product xlfdp, in human plasma.

Refer to package insert for complete instrument listing. Access important information about chemistry reagents and immunosuppressant drug monitoring assays, including application sheets, package inserts, safety data sheets, and videos. Ddimer level is a useful tool for the evaluation of risk of vte recurrence in such patients 12, 14, 17, 18. For additional information, refer to the alere triage meter user manual. Treatment day gamifant dose criteria for dose increase if abnormal at baseline and no. Ddimer results are critical to the diagnostic algorithm for the exclusion of vte in low and moderate pretest probability patients and their use is guided by clsi document h59a. Axsym d dimer is based on microparticle enzyme immunoassay meia technology. The stratus cs ddimer assay is intended for use in conjunction with a nonhigh clinical pretest probability ptp assessment model to exclude pulmonary embolism pe disease and as an aid. First d dimer test cleared by the fda for exclusion of pe and dvt. The ddimer test is a quick way to check if you might have a serious blood clot. To demonstrate reliable clinical performance and compliance with the rigorous requirements of clsi h59a. It aims to better serve our customers while helping to preserve the planet.

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