hs-cTnl CLIA Test CE

The high sensitivity Cardiac Troponin I (hs-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.

Cardiac troponins are sensitive and specific biomarkers used in clinical diagnosis of acute myocardial infarction (AMI).

Troponins appear 4-12 hours after the onset of AMI symptoms and remain abnormally high for 4-10 days in serum. Although conventional troponin assays are valuable diagnostic tools, their sensitivity are lower within the first few hours of symptom onset

The hs-cTnI assays provide higher sensitivity and improved precision than conventional assays. This higher analytical performance of hs-cTnI assays facilitates early diagnosis, risk stratification and effective patient management with early symptoms.

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

Range

Working range: 0.005 – 50 ng/mL.

Detection Limits

Limit of Blank (LOB): ≤ 0.005 ng/mL.

  1. Precision

Intra-lot Precision

CV less than 8%

Inter-lot Precision

CV less than 10%

  1. Linearity

Linearity between 0.05 and 50 ng/mL.

  1. Analytical Specificity

The following muscle proteins were tested and found to have an insignificant effect on the measured cTnl.

SubstanceConcentration% 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
Hemoglobin≤500 mg/dL
Bilirubin≤20 mg/dL
Triglyceride≤3000 mg/dL
Total Protein≤10 g/dL
Rheumatoid Factor≤1500 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 hs-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 Lyophilized powder calibrators 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 gloves
CATALOG #PRODUCTQUANTITYSPECIMEN
L3003hs-cTnl CLIA Test60/kitS/P/WB
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FOR EXPORT ONLY