Nanjing Synthgene Medical Technology Co., Ltd

【Product name】 CK-MB Rapid Test Kit (Colloidal gold method)  

【Packaging specifification】 1/5/10/25/50/100 test(s)/kit  

【Intended use】 This kit is used for clinical in vitro qualitative detection of creatine kinase  isoenzyme (CK-MB) in human serum/plasma/whole blood. Creatine kinase isoenzyme (CK-MB) is an isoenzyme of creatine kinase. Creatine  kinase (CK) is a highly sensitive indicator of myocardial infarction. It can be  detected in the blood of patients in the early stage when myocardial cells have not  been necrotic in a large area, and can be used as a reliable first diagnosis for clinical  myocardial infarction. After acute myocardial infarction (AMI), CK-MB increases  at 3-8 hours, peaks at 8-24 hours, and returned to normal at 48-72 hours, the pattern  of rise and fall indicates for myocardial injury. During myocardial infarction, serum  CK-MB levels increase to 10-25 times the normal level. Therefore, the detection of  CK-MB can provide a basis for physicians in the early diagnosis of AMI.  The determination of CK-MB mainly includes enzymatic method and mass method.  The mass method can avoid possible interference in the determination of enzymatic  activity, and has higher sensitivity and accuracy. The common detection methods of  CK-MB in clinical or laboratory are fluorescence immunochromatography,  chemiluminescence method, etc. The methodology used in this kit is colloidal gold  method. 

【Testing principle】 This product adopts the double antibody sandwich method, and the determination is  carried out in the form of solid-phase immuno-chromatography. The sample to be  tested diffuses upward by capillary force at the sample end, and when passing  through the binding pad, the CK-MB in the sample combines with the colloidal gold  mouse anti-human CK-MB monoclonal antibody 1 conjugate to form a colloidal  gold-labeled antibody-antigen complex. The colloidal gold-labeled antibody-antigen complex continues to diffuse upward to the nitrocellulose membrane with the  sample, and is intercepted by the T line (detection line) coated with mouse anti-human CK-MB monoclonal antibody 2 to form colloidal gold labeled antibody-antigen-coated antibody immune complexes. The un-intercepted colloidal gold-labeled  complexes continue to move upward, and bind to the goat anti-mouse IgG antibody  coated on the C line (quality control line), indicating the completion of the reaction.  CK-MB in the sample is qualitatively detected by visually inspecting the color  development of the detection line under natural light.

【Main components】

1. Test pad, individually packaged in aluminum foil bag (1/5/10/25/50/100  piece(s)/kit) 

2. Disposable plastic straw(1/5/10/25/50/100 piece(s)/kit) 

3. Instruction manual (1 copy/kit) 

Note: The components in kits of different batch numbers are non-interchangeable.