Biochip Langdao (Tianjin)Medical Technology Limited

1.Product Overview

[Product Name] : Creatine kinase isoenzyme (CK-MB)

[Package Specification] : 30 tests/kit;60 tests/kit

[Applicable Device] : CLite-160i

[Specimen Type] : plasma

[Storage] : 2-8℃

[Product validity] : 12 months

[Detection method] : magnetic particle chemiluminescence method

2.technique principle

Double antibody sandwich method was used in the kit. The detection principle is: the sample to be tested, R1 reagent, R2 reagent and M reagent are mixed for incubation, and the fluorescein (FITC) labeled CK-MB antibody 1 in R1 reagent and the alkaline phosphatase (ALP) labeled CK-MB antibody 2 in R2 reagent are combined with the CK-MB antigen molecules in the sample to form an immune complex. The immune complex is further captured by anti-FITC antibodies coupled to the surface of the magnetic particle and adsorbed to the surface of the magnetic particle. After washing, the unbound material was removed and the luminescent substrate was added, ALP catalyzed the luminescence of the substrate, and the relative luminescence intensity (RLU) was determined

3.Clinical significance

Creatine kinase (CK) is a dimeric enzyme with four isoenzyme forms: mitochondrial creatine kinase, CK-MM (muscle), CK-BB (brain), and CK-MB (hybrid).The concentration of CK-MB in plasma is an important indicator for the diagnosis of myocardial ischemia diseases such as acute myocardial infarction and myocarditis. CK-MB can be detected in the blood 3 to 8 hours after the onset of cardiac symptoms and can remain detectable for long periods, depending on the course of the disease. CK - MB also can appear in other clinical diseases, such as rhabdomyolysis and stroke. Within the scope of laboratory diagnosis, measurement of total CK, troponin I, troponin T, and myoglobin is helpful for clinical differentiation.

4.Product features and indicators

High sensitivity: the detection limit is not higher than 0.3ng/mL;

Wide linear range: [0.3,300] (ng/mL) within the scope of sample without dilution;

Good correlation: correlation R > 0.95 with ROCHE reagent;

Good stability: the calibration cycle can be up to 14 days, the reagent can be stored at 4℃ for 1 year;

Fast results: only 16-18 minutes to get results.