Myoglobin CLIA Test CE

The Myoglobin (MYO) Chemiluminescence ImmunoAssay (CLIA) Test is a chemiluminescence-based immunoassay for the quantitative detection of Myoglobin in human serum or plasma (Lithium heparin, EDTA) using the ALTA CLIAlyzer.

Myoglobin is an iron- and oxygen-binding protein found in the heart and skeletal muscles. In the human body, myoglobin is only found in the bloodstream after injury to the heart or muscle tissues. When injury occurs, myoglobin can be rapidly released into the blood and exceeds its normal levels in about one hour. Thus, myoglobin is a sensitive marker for heart or muscle injury, making it a potential indicator of heart attack in patients with chest pain. However, elevated myoglobin has low specificity for acute myocardial infarction (AMI). Therefore, CK-MB, cardiac Troponin, ECG, and clinical signs should be taken into account when making a diagnosis.

The Myoglobin CLIA Test was developed to detect the concentration of myoglobin in serum and plasma.

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

Range

Working range: 1-1000 ng/mL

Detection Limits

Limit of Blank (LOB) :1 ng/mL

Precision

Intra-lot Precision

CV less than 8%

Inter-lot Precision

CV less than 10%

Linearity

Linearity between 1-1000 ng/mL

Interference

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

SubstanceConcentration
Hemoglobin≤ 500 mg/dL
Bilirubin≤ 40 mg/dL
Triglyceride≤ 3000 mg/dL
Total Protein≤ 5 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 Myoglobin concentration up to 10000 ng/mL.

Reagents and materials provided

  1. 19-well myoglobin 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 myoglobin protein at:
    1. 0 ng/mL
    2. 25 ng/mL
    3. 500 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 Ml
  2. For other specific materials and disposables, refer to CLIAlyzer user manual
  3. CLIAlyzer instrument
  4. Powderless gloves
CATALOG #PRODUCTQUANTITYSPECIMEN
L3030Myoglobin CLIA Test36/kitS/P
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FOR EXPORT ONLY