Evidence-based, Accurate, High-sensitivity Troponin I Results
99th URL (ng/L)
Streamlined Patient Testing Workflow
- Sample type flexibility: The system can produce results on lithium-heparin whole blood, lithium-heparin plasma, and capillary samples.
- Sample volume: minimum of 30 µL of blood required to perform the test.
- Test results are sent securely through our POC Ecosystem™ Solution via WI-FI or Ethernet for storage in the LIS/HIS and EMR.
Clinical value of high-sensitivity cTn from ESC Guidelines2
Compared with conventional troponin assays:
- Higher NPV for AMI
- Reduced “troponin-blind” interval, leading to earlier detection of AMI
- Result in ~4% absolute and ~20% relative increases in the detection of type 1 MI and corresponding decrease in the diagnosis of unstable angina
- Associated with 2-fold increase in the detection of type 2 MI
Levels of hs-cTn are quantitative markers of cardiomyocyte damage:
- Elevations greater than 5 times the URL have high (90%) PPV for acute type 1 MI.
- Elevations up to 3 times the URL have limited (50–60%) PPV for AMI.
- It is common to detect circulating levels of cardiac troponin in healthy people.
Rising and/or falling cardiac troponin levels differentiate acute from chronic cardiomyocyte damage.
The cartridge is disposable (single-use) and specific for one or more assays, with no warm-up time from refrigerated storage.
Each disposable cartridge is identified by a unique Radio Frequency identification (RFID) chip, that contains information on the type of test, calibration data, and lot-specific information.
- Instructs the instrument to automatically starts the correct assay protocol
- Integrated assay quality control in every cartridge
Troponin: High-Sensitivity vs. Contemporary1
- Contemporary assays must detect cTn in 20% to <50% of healthy individuals.
- High-sensitivity assays must detect cTn in at least 50% of healthy individuals and must have <10% CV at the 99th percentile of normal.
- Units of measure:
- Contemporary: ng/mL
- High-sensitivity: ng/L
- Software version/validity
- Electronic system
- Temperature control system
- Storage space
- Imaging system
- Analyzer orientation
- Battery level
- Magnetic system
- RFID version/validity
- Cartridge use data
- Light intensity reference
- Cartridge type
- Cartridge alignment
- No sample added
- Expiry date
- Optical image quality
- Sample application
- Cartridge filling time
- Sample volume check
- Analyzer cap closed
- Cartridge temperature
- Dynamic readout
- Power button disabled
- Light intensity
- Cartridge movement
- Analyzer orientation/shock