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PATHFAST™ high sensitivity troponin I

PATHFAST™ high sensitivity troponin I
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high sensitivity troponin I

PATHFAST TM hs-cTnI: early and immediate diagnosis of MI in the emergency department (ED) PATHFASTTM hs-cTnI is a chemiluminescent enzyme immunoassay (CLEIA) for quantitative measurement of cardiac troponin I (cTnI) concentration in whole blood or plasma at the point of care (POC). Low concentrations of cTnI can be analysed by using high sensitivity cardiac troponin (hs-cTnI) assays which meet the criteria defined by IFCC and ESC (1,2). PATHFAST TM provides high accuracy and precision of test results similar to central lab analyser, combined with the flexibility of a POCT assay within 17...

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PATHFAST™ high sensitivity troponin I - 3

Criteria for a high sensitivity cTn assay Fig. 2A: omparison ROC of PATHFASTTM and one central C LAB assay for NSTEMI patients at admission Recommendation from IFCC (1) 99th percentile of hs-assays should be measured with an analytical imprecision of <10% CV hs-cTn assays should measure cTn above the limit of detection (LOD) in 50% of healthy individuals Gender specific 99th percentile values should be established for men and women Recommendation from ESC guideline (2,3) rule-out or a 0 h /1 h rule-in/rule-out algorithm by using high sensitivity troponin assays as an alternative to the For...

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PATHFAST™ high sensitivity troponin I - 4

0 h / 1h Rule-out algorithm of NSTEMI for PATHFASTTM hs-cTnI A rule-out of NSTEMI is possible by the combination of a baseline concentration below a cut off level B and the delta from 0 h to 1 h < C (Fig. 3). 2015 ESC Guidelines recommend that in large validation cohorts the NPVs for rule-out of NSTEMI should exceed 98% (2). A diagnostic algorithm for a high-sensitive troponin I point of care assay was developed in a derivation dataset with 669 patients and validated in additional 610 patients. For PATHFAST TM hs-cTnI wide range of the combination was tested for 1.221 patients with...

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PATHFAST™ high sensitivity troponin I - 5

PATHFAST TM Test Principle PATHFAST TM Technical Specifications Instrument type Throughput Measuring time Sampling material Measuring principle Reaction temperature Sample volume Data storage Datatransfer Weight El. requirements Power consumption Monitor/keyboard Printer PC Interface Calibration 24-h operation (stand-by) Desktop Immunoassay Analyzer Up to 6 samples or parameters per run <17 minutes for 6 samples using emergency markers or PATHFASTTM Presepsin Whole blood, plasma, serum Chemiluminescence enzyme immunoassay technology (CLEIA) and Magtration® technology. 37 °C 100 µl Patient...

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PATHFAST™ high sensitivity troponin I - 6

Product List PATHFAST TM for critical care and sepsis diagnostics Item number Pack size PATHFAST TM pipette tips PATHFAST TM B.R. A.H.M.S PCT control set PATHFAST TM Presepsin control set SYSTEM PATHFAST TM Immunoanalyser Analyzer for the detection of cardiac and other emergency parameters and sepsis CONSUMABLES AND ACCESSORIES REAGENT KITS FOR CRITICAL CARE DIAGNOSTICS PHC Europe B.V. Nijverheidsweg 120, 4879 AZ Etten-Leur, The Netherlands Phone: + 31 76 543 38 33 email: marketing@eu.phchd.com REAGENT KITS FOR SEPSIS DIAGNOSTICS

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