- Individual ready-to-use cartridges
- Combines the sandwich immunoassay technique with enzyme-catalyzed chemiluminescence detection
- Sample volume: 75 μL
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.
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:
Substance | Concentration |
Hemoglobin | 1000 mg/dL |
Bilirubin | 34 mg/dL |
Triglyceride | 1500 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 CK-MB concentration up to 5000 ng/mL.
Reagents and Materials Provided:
- 19-well CK-MB reagent cartridge
- Sample well
- Reading well for chemiluminescent signal (19th well)
- Foil-sealed wells (2nd to 18th wells) comprised of a barcode indicating reagent assay information, the reagent lot number and the expiration date
- 3 Calibrators lyophilized powder with CK-MB at:
- 0 ng/mL
- 5 ng/mL
- 50 ng/mL
- Registration card
- Calibrator card
- Instructions for Use
Materials may be required and not provided:
- Commercial controls
Materials required but not provided:
- Pipette with disposable tip to dispense up to 100 μL
- For other specific materials and disposables, refer to CLIAlyzer user manual
- CLIAlyzer instrument
- Powderless gloves
CATALOG # | PRODUCT | QUANTITY | SPECIMEN |
L3020 | CK-MB CLIA Test | 60/kit | S/P/WB |
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MATERIALS REQUIRED BUT NOT PROVIDED… | |||
CLIA-1 | CLIAlyzer |
FOR EXPORT ONLY