Alere poc 7d2628 determine rapid tests wilburn medical usa. Ddimer tats insufficient to make rapid clinical decisions for imaging. Contact with reagents within the test device may cause irritation. The alere triage ddimer test is a fluorescence immunoassay to be used with. Evaluation of the alere ddimer test for point of care testing article in journal of thrombosis and thrombolysis 382 august 2014 with 626 reads how we measure reads. Alere triage ddimer test product insert pi, english quidel. Refer to your manufacturer insert or contact your manufacturer for the. The ddimer values are presented in units of mass ngml of ddimer, also known as ddimer units ddu. Alere triage meterpro d dimer method and sample collection iecdd. It is useful as an aid in management and monitoring of post. Triage cardioprofiler panel pn 97100cp triage cardiac panel pn 97000hs triage profiler sob panel pn 97300 triage bnp pn 98000xr triage ddimer pn 98100 modelcataloglot numbers. The tip is available for order in a 500count package, as well as a new, 100count package.
The alere triage bnp test is a single use fluorescence immunoassay device designed to. Ddimer, a product of crosslinked fibrin degradation, is only produced when both the blood coagulation and fibrinolytic pathways are concomitantly activated. Troponin i, ntprobnp, ckmb, ddimer, hscrp and myoglobin ability to run whole blood or plasma samples testing and results unaffected by hemolysis six simultaneous tests in under 17 minutes flexibility to perform any of the assays from one to six tests per run single test reagent cartridge. Quantitative determination of crp hba1c ualbumin ddimer axisshield axisshield poc as pa rt of t he ax iss eld g up p. Ddimer can be measured and reported in either fibrinogen equivalent units feu or ddimer units ddu. Alere triage ddimer test product insert pi, english. Without ddimer screening, the positive rate is 5% 8% irradiates patients the radiation from one chest ct. Nycocard ddimer measures ddimer configurated molecules, which are released into the circulation by the activation of the fibrinolysis system.
Ddimer determination is mainly used to exclude deep vein thrombosis of the leg and pulmonary embolism. The quidel triage d dimer test is a rapid, quantitative immunoassay to aid in assessing and evaluating patients with suspected disseminated intravascular coagulation dic and thromboembolic events including pulmonary embolism pe and deep vein thrombosis dvt. Leelewandrowski and collaborators specifically evaluated the impact of implementing a poc ddimer assay biosite triage, biosite diagnostics now alere inc in the emergency department. The test device was inserted into the triage meter, and fluorescent signals are measured in approximately 20 min. Our systems, reagents and tests help you deliver accurate, timely results and support the improvement of patient care worldwide and our enzymes and specialty biochemicals foster the development and delivery of quality products for laboratory and research environments. The role of ddimer in venous thromboembolic disease and. Widely used types and clinical applications of ddimer. Alere triage ddimer test package insert english alere triage ddimer test sds english alere triage ddimer test total 5 calibration verification package insert multilingual alere triage total 5 controls package insert multilingual how to buy. Ntprobnp results are used as an aid to assist in the diagnosis and assessment of severity of congestive heart failure chf and risk stratification in patients with acute coronary syndromes acs. Sekisui diagnostics has a broad product portfolio to meet your diagnostics needs. Introduction to individualized quality control plan iqcp the new qc policy from cms.
Online order request or contact your local distributor. Retrieve technical documents for our entire portfolio of instruments, assays and test kitsall with a single pointofaccess. Quidel triage meterpro total controls level 1 includes bnp. The end of the dispensing tip aligns with the cartridge port to allow the enduser to moreeasily and accurately dispense the desired amount of blood. Ddimer hs 0020007700 english insert revision 042010 intended use hemosil ddimer hs is an automated latex enhanced immunoassay for the quantitative determination of ddimer in human. Can a pointofcare troponin i assay be as good as a central. Evaluation of the alere ddimer test for point of care. The study shows that the alere ddimer assay and the central laboratory standard assay show similar results. With ddimer screening, the positive rate of ct scans for pe is 11%. Refer to the alere triage meter user manual for complete instructions for. Level l ddimer hs 500 control is intended for the assessment of precision and accuracy of the assay around the clinical cutoff for vte 500nglml feu. Kinetic measurement of the ddimer concentration at 700nm absorbance.
This can lead to poor correlation between methods reporting results in ddu. Quidel triage meterpro total controls level 1 includes. Package insert ddimer fs english diasys diagnostic systems. Ddimer is a soluble fibrin degradation product deriving from the plasminmediated. Quidel triage meterpro total controls level 1 includes bnp, d dimer, ckmb, myo, tni 5 vials per box triage total 5 controls are assayed materials to be used with the triage cardiac panel, triage bnp. Calibration verification control panel triage control 5 5. Troponin i, ntprobnp, ckmb, ddimer, hscrp and myoglobin ability to run whole blood or plasma samples testing and results unaffected by hemolysis six simultaneous tests in under 17. D dimer is a soluble fibrin degradation product deriving from the plasminmediated degradation of crosslinked fibrin. Alere triage meterpro ddimer method and sample collection10. The packaging rebrand will take place over the next 12 months. We wanted to let you know that fisher healthcare surevue test kits have a new look. Four key cms regulations for moderately complex tests. Cv for the alere ddimer method was well below 10 %.
Ddimer ichroma ddimer is a fluorescence immunoassay fia for the quantitative determination of ddimer in human whole blood plasma. Alere triage d dimer test quickly, easily, and inexpensively assess patients suspected of having pedvt in about 15 minutes with the alere triage d dimer test. Ddimer can hence be considered a biomarker of activation of coagulation and. Alere triage meterpro troponin i method and sample collection. In order to be evaluated appropriately, you must report the correct unit of measure. Disclaimers i work for alere alere produces testing devices for use at poc working with customers is my passion. User manual for complete instructions on use of the qc device. Through this activation, fibrin is degraded by plasmin to various soluble fragments in which the d dimer configuration occurs. Manufacturers were encouraged to contact their clients to promote the use of only the type and magnitude of ddimer units provided in the package. Disseminated intravascular coagulation dic in dic the fibrinolytic system is activated and therefore the ddimer level increases.
The alere triage ddimer test has been standardized using a purified protein preparation of ddimer based on the mass concentration of the analyte present in edta anticoagulated plasma. The alere triage ddimer test is a fluorescence immunoassay to be used with the alere. If decision limits are not provided in the package insert or fda summary information, institutional cutoffs must be established. It is designed for routine use to aid in verifying proper performance of the procedure and the antigen detection reagents of the alere binaxnow malaria test.
D dimer is a coagulation marker that reflects the degree of thrombin turnover. Deep venous thrombosis pulmonary embolism, ddimer and. Disseminated intravascular coagulation dic in dic the fibrinolytic system is activated and therefore. User manual for complete instructions for use of the. Preanalytical, analytical, postanalytical variables. First of all a comparison should be primarily a clinical comparison because the specificities for ddimer assays can be in the range from 30 to above 90 % 1. Iqcps must at minimum have a ra evaluation of the following components. The alere binaxnow malaria positive control is intended for use as an assayed positive external quality control with the qualitative alere binaxnow malaria test. The alere triage ddimer test is a fluorescence immunoassay to be used with the alere triage meters for the quantitative determination of crosslinked fibrin degradation products containing ddimer in edta anticoagulated whole blood and plasma specimens. If youve recently purchased or plan to purchase any surevue products in the future, just keep in mind that the packaging has changed. D dimer can hence be considered a biomarker of activation of coagulation and.
The document library provides customers with a single pointofaccess to technical documents for our entire portfolio of instruments, assays and test kits. Alere triage ddimer test 98100 98100eu alere triage 8 panel for drugs of abuse 90008. Alere triage meterpro the alere triage meterpro is a highperformance, comprehensive testing platform for use in the. Individualized quality control plan iqcp iqcps are a formal representation and compilation of risk assessment ra, quality control plan qcp, and quality assessment qa. Nycocard d dimer measures d dimer configurated molecules, which are released into the circulation by the activation of the fibrinolysis system. Introduction to individualized quality control plan iqcp.
The istat dispensing tip streamlines the bloodtransfer process to the istat test cartridge. There are no international standards for ddimer and different assays use antibodies with differing speci. List of medical device recalls alere, triage multiple tests. Alere triage meterpro troponin i method and sample. Widely used types and clinical applications of ddimer assay. It is an immunochromatographic dipstick test that detects. The alere medical test device test device kit is composed of hard plastic parts andor vials of diluents, conjugates, substrates, and wash solutions some of which are coated with or contain minute quantities of immunoassay reagents and stored in a sealed pouch containing desiccant. How to use ddimer in acute cardiovascular care sage journals. Level 2 d dimer hs 500 control is intended for the assessment of precision and accuracy of the assay at abnormal d dimer levels above the cutoff.
Alere medical test devicetest device kit safety data sheet according to regulation ec no. 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. Level l d dimer hs 500 control is intended for the assessment of precision and accuracy of the assay around the clinical cutoff for vte 500nglml feu. It is vital that you refer to the manufacturers package insert to determine the type of units that you report with the test that you are using. However, spurious ddimer results were observed on the sta analyzer after adding high. Ddimer is a soluble fibrin degradation product deriving from the plasminmediated degradation of crosslinked fibrin. Alere triage ddimer test quickly, easily, and inexpensively assess patients suspected of having pedvt in about 15 minutes with the alere triage ddimer test. Can a pointofcare troponin i assay be as good as a.
Through this activation, fibrin is degraded by plasmin to. Evaluation of the alere ddimer test for point of care testing. D dimer, a product of crosslinked fibrin degradation, is only produced when both the blood coagulation and fibrinolytic pathways are concomitantly activated. 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.
Manual elisas do not meet the recommended tat, whilst recent central laboratory. 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. The comprehensive test menu includes cardiovascular, renal, toxicology, and womens health assays some assays not available in. Leelewandrowski and collaborators specifically evaluated the impact of implementing a poc ddimer assay biosite triage, biosite diagnostics now alere inc in the emergency department of a large urban academic medical center where the vidas ddimer central laboratory assay biomerieux sa was also used. Alere medical test devicetest device kit safety data sheet sds4616 according to regulation ec no. Assay menu immunoassay cancer afp ca 125 ii ca 153 ca 199 xr cea cyfra 211 free psa he4 pivkaii progrp roma scc total psa ca724 nse cardiac bnp galectin3 stat high sensitive troponini alere ntprobnp for alinity i stat ckmb stat myoglobin fertility pregnancy bhcg dheas estradiol fsh lh progesterone prolactin shbg 2nd gen. Pdf ddimer is a soluble fibrin degradation product deriving from the plasmin mediated degradation of crosslinked. The vidas ddimer was the first assay to achieve an exclusion claim for dvtpe and was the best assay on the market a negative vidas ddimer could be used to exclude dvtpe with a relatively high. Quantitative ddimer assay student health center manuals. The alere medical test device test device kit is composed of hard plastic parts andor vials of diluents, conjugates, substrates, and wash solutions some of which are coated with or contain minute. This assay is a monoclonal anti ddimer antibody coupled to latex particles that forms high molecular weight immunocomplexes. Refer to package insert of currently available lots for specific analyte, amr, and stability claims.
If youve recently purchased or plan to purchase any surevue products in the future, just. Calibration verification linearity, analyzer index. Ddimer level is a useful tool for the evaluation of risk of vte recurrence in such patients 12, 14, 17, 18. It is useful as an aid in management and monitoring of post therapeutic evaluation of thromboembolic disease patients. Alere triage meterpro ddimer method and sample collection iecdd. Triage cardioprofiler panel pn 97100cp triage cardiac panel pn 97000hs triage profiler sob panel pn. Alere triage bnp calibrators 98202 alere triage ddimer test alere triage ddimer test 98100 alere triage. Alere triage meterpro troponin i method and sample collection iectni.
List of medical device recalls alere, triage multiple. Pdf ddimer is a soluble fibrin degradation product deriving from the plasminmediated degradation of crosslinked. Ddimer assays can help in the diagnosis of dic, and in dic patients management 5, 8, 14, 18. Include the correct units that you use clinically ie, ngml. The alere triage bnp test offers an objective, noninvasive measurement for assessing patients for chf and risk stratification in patients with acute coronary syndromes acs. Assay performance characteristics are reported in table 2 10. The quidel triage ddimer test is a rapid, quantitative immunoassay to aid in assessing and evaluating patients with suspected disseminated intravascular coagulation dic and thromboembolic events. Calibration verification control panel triage control 5 5 levels 2 x 0. The alere triage meterpro is a highperformance, comprehensive testing platform for use in the laboratory or at the point of care, and is the trusted choice in thousands of hospitals and physician offices worldwide.