CK-MB In Vitro Diagnostic Reagents Chemiluminescencross Creatine Kinase Isoenzymes For Automatic Immunoassay Analyzer

CLIA Reagents of Inflammation (CK-MB)

【Expected usage】
This product is used to quantitatively detect the content of creatine kinase isoenzyme in human serum in vitro.

Creatine kinase (CK) is a dimeric enzyme that exists in four different forms: the mitochondrial and cytosolic isoenzymes CK-MM (muscle type), CK-BB (brain type) and CK-MB. The detection value of CK-MB in serum is an important indicator for the diagnosis of myocardial ischemia (such as acute myocardial infarction, myocarditis, etc.). CK-MB isoenzyme mainly exists in the myocardium, accounting for 20% of the total activity of CK. More than 5% of CK-MB is present in the prostate, spleen, or skeletal muscle, and the amount of CK-MB varies with muscle type function. When acute myocardial infarction (AMI) occurs, CK-MB appears in the blood circulation and indicates that the myocardium is damaged. CK-MB rises ly to peak values ​​(within 12 hours) and then declines to normal levels (36–72 hours). This rising and falling variation of the CK-MB value, accompanied by the evolution of the ECG (electrocardiogram) and a history of chest pain, is generally considered to be the diagnosis of AMI. Detection of CK-MB also facilitates the non-invasive assessment of the efficacy of multiple perfusions in the myocardium under thrombolytic therapy.

At present, the content of creatine kinase isoenzyme is clinically detected, and the methodologies used are mostly radioimmunoassay, enzyme immunoassay, chemiluminescence method, colloidal gold method and immunoturbidimetric method.

【Inspection Principle】
This kit adopts the principle of direct sandwich method, uses magnetic microparticles as the solid phase of immune reaction, and uses chemiluminescence enzyme-linked immunosorbent assay method to cooperate with chemiluminescence measuring instruments to detect the content of creatine kinase isoenzyme in human serum.

The technical principle is: Fluorescein isothiocyanate (FITC)-labeled mouse monoclonal anti-CK-MB antibody paired with alkaline phosphatase (AP)-labeled mouse monoclonal anti-CK-MB antibody and samples, calibrators or The CK-MB in the control product binds to form a "sandwich" complex. Then, the magnetic particles linked with goat anti-FITC antibody are added, and the antigen-antibody immune complex is bound to the magnetic particles through the specific binding of the anti-FITC antibody and FITC.

Under the action of an external magnetic field, the complex formed by the immune reaction is separated from other unbound substances, and after washing the complex, an enzymatic chemiluminescence substrate is added. The substrate is catalytically cleaved under the action of the enzyme to form an unstable excited state intermediate.

When the excited state intermediate returns to the ground state, photons are emitted to form a luminescence reaction, and the luminescence intensity of the reaction can be detected by a chemiluminescence instrument. In the detection wavelength range (230-700nm), the luminescence intensity is proportional to the content of CK-MB in the sample, and the CK-MB concentration in the sample can be calculated by fitting the modified four-parameter Logistic equation.