cTnl CLIA Test CE

The Cardiac Troponin (cTnI) Chemiluminescence ImmunoAssay (CLIA) Test is a chemiluminescence-based immunoassay for the quantitative detection of cTnI in human serum, plasma (lithium heparin, EDTA), or whole blood using the ALTA CLIAlyzer.

The creatine troponin complex, consisting of cardiac muscle troponin I (cTnI), troponin T (TnT) and troponin C (TnC), can adjust the interaction between actin and myosin. Concentration of cTnI is typically low in healthy human blood. However, when an acute myocardium infarction occurs, cTnI is released into the blood quickly, which leads to a rapid increase of cTnI concentration within hours and can last 6 to 10 days.

Therefore, the concentration of cTnI in blood or plasma is regarded as a marker for myocardial infarction. The cTnI CLIA Test is intended to detect cTnI in human serum, plasma or whole blood.

  • Individual ready-to-use cartridges
  • Combines the sandwich immunoassay technique with enzyme-catalyzed chemiluminescence detection
  • Sample volume: 75 μL

Range

Working range: 0.05 – 50 ng/mL

Detection Limits

Limit of Blank (LOB): ≤ 0.045 ng/mL

Precision

Intra-lot Precision

CV less than 8%

Inter-lot Precision

CV less than 10%

Linearity

Linearity between 0.05 and 50 ng/mL

Analytical Specificity

The cTnI assay is specific for cardiac troponin I. The following muscle proteins were tested and found to have an insignificant effect on the measured cTnL.

Substance Concentration Percent Cross reactivity
Troponin C (cardiac)1000 ng/mL≤ 0.1%
Troponin T (cardiac)1000 ng/mL≤ 0.1%
Troponin I (skeletal)1000 ng/mL≤ 0.1%

Interference

No significant interference was detected up to the concentrations mentioned below:

SubstanceConcentration
Hemoglobin500 mg/dL
Bilirubin20 mg/dL
Triglyceride3000 mg/dL
Total Protein10 g/dL
Rheumatoid Factor1500 IU/mL

HAMA Interference

Patient specimens containing human anti-mouse antibodies (HAMA) may give falsely elevated or decreased values.  Although HAMA-neutralizing agents are added, extremely high HAMA serum concentrations may occasionally affect the results.

Hook effect

There is no high-dose hook effect at cTnI concentration up to 1000 ng/mL.

Reagents and Materials Provided

  1. 19-well cTnI reagent cartridge
    1. Sample well (1st well)
    2. Reading well for chemiluminescent signal (19th well)
    3. Foil-sealed wells (2nd to 18th wells) comprised of a barcode indicating reagent assay information, the reagent lot number and the expiration date
  2. 3 Calibrators lyophilized powder with human cardiac troponin I protein at:
    1. 0 ng/mL
    2. 3 ng/mL
    3. 10 ng/mL
  3. Registration card
  4. Calibrator card
  5. Instructions for Use

Materials may be required and not provided

  1. Commercial controls

Materials required but not provided

  1. Pipette with disposable tip to dispense up to 100 μL
  2. For other specific materials and disposables, refer to CLIAlyzer user manual
  3. CLIAlyzer instrument
  4. Powderless glove
CATALOG #PRODUCTQUANTITYSPECIMEN
L3002cTnl CLIA Test60/kitS/P/WB
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FOR EXPORT ONLY