CK-MB CLIA Test CE

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

Creatine kinase (CK) is an enzyme composed of two subunits, M and/or B, in three different possible combinations that give rise to three different isoenzymes: CK-MB, CK-BB, and CK-MM. The isoenzymes are normally present in the cytosol, in different tissues: CK-MB is expressed in cardiac muscle, CK-MM is expressed in skeletal muscles and the heart, and CK-BB is expressed in the brain and smooth muscles. Upon body injury, they are released into the blood and result in abnormal increased concentrations in serum or plasma. As a heart-specific isoenzyme, CK-MB can be used to assist diagnoses of an acute myocardial infarction. The levels of CK-MB in blood elevate in 3-6 hours after acute myocardial infarction, peak between 12-24 hours and then return to normal within about 48-72 hours. Other tests or diagnosis should be performed for comprehensive evaluations.

The CK-MB CLIA Test was developed to detect the concentration of CK-MB in 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: 0.3 ng/mL~300 ng/mL

Detection Limits

Limit of Blank (LOB): ≤ 0.1 ng/mL

Precision

Intra-lot Precision

CV less than 8%

Inter-lot Precision

CV less than 10%

 Linearity

 Linearity greater than 0.9900 between 0.3 to 300 ng/mL

 Interference 

 No significant interference was detected up to the concentrations mentioned in the following table:

SubstanceConcentration
Hemoglobin1000 mg/dL
Bilirubin34 mg/dL
Triglyceride1500 mg/dL
Total Protein5 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 CK-MB concentration up to 5000 ng/mL.

Reagents and Materials Provided:

  1. 19-well CK-MB reagent cartridge
    1. Sample 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 CK-MB at:
    1. 0 ng/mL
    2. 5 ng/mL
    3. 50 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
L3020CK-MB CLIA Test60/kitS/P/WB
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FOR EXPORT ONLY