PHC Corporation

PATHFAST™ - Emergency Marker

High sensitivity Troponin I

Emergency Marker

Features

Diagnosis of Acute Myocardial Infarction (AMI)

PATHFAST™ determines the quantity of hs Trop INTproBNPD-DimerhsCRPMyoglobinCK-MB massBRAHMS PCT and Presepsin. From one single whole blood sample. The quantitative data of the parallel analyses provide results within minutes, which facilitate the therapeutical decision. Basis for a safe diagnosis on-site for patients with acute coronary syndrome, suspected coronary heart insufficiency, venous thromboembolism, inflammation and myocardial injury.

PATHFAST™ hs-cTnI is an immunoassay for the in vitro quantitative determination of cardiac Troponin I (cTnI) in human anticoagulated whole blood and plasma on the PATHFAST™ analyzer. PATHFAST™ hs-cTnI can be used as an aid in the diagnosis of acute myocardial infarction and in the risk stratification of patients presenting with acute coronary syndromes. In addition to the diagnosis of AMI, detection of low cardiac troponin levels may make it possible to predict information (risk stratification) in terms of short- and long term mortality of patients. 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. PATHFAST™ provides high accuracy and precision of test results similar to central lab analyser, combined with the flexibility of a POCT assay below 17 minutes out of whole blood and plasma by all in one cartridge solution. The new PATHFAST™ hs-cTnI assay fits for the recommen[1]dations on the IFCC and ESC guidelines for the early detection of AMI.

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Assay Specifications

Method Chemiluminescent Enzyme Immuno Assay - Magtration
Sample Material - Heparin-whole Blood
- Heparin-Plasma
- EDTA-whole Blood
- EDTA-Plasma
Sample Volume 100 μl
Reference Values < 29 ng/L | 99th %
Test Duration < 17 Minutes
Durability of Calibration 28 Days
Measurement Range 2,33 - 50 000 ng/L
Limit of Detection 2,33 ng/L
Pack size 60 tests

* for more detailed information, please refer to the instruction for use, delivered with each reagent

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