Nanjing Synthgene Medical Technology Co., Ltd

【Product name】 cTnI 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 cardiac troponin I (cTnI)  in human serum/plasma/whole blood. Troponin (trporin, Tn) is a structural protein that constitutes striated muscle  filaments, and its subunits I, T and C form a complex. The content of cTnI in normal  blood is very low. After myocardial injury, the cardiac troponin complex is released  into the blood. After 4 to 6 hours, the elevated cTnI can be detected in the blood,  which remains in the blood for 6 to 10 days, providing a longer detection period.  cTnI has high myocardial specificity and sensitivity, so it has become the "gold  standard" for acute myocardial infarction (AMI). The clinical significance of cTnI  detection lies in: early diagnosis and risk stratification of AMI; assessment of  myocardial ischemic injury area and clinical treatment effect; auxiliary diagnosis  and detection of myocardial injury diseases caused by various reasons.  cTnI is currently detected in clinical or laboratory methods using chemiluminescence, fluorescence immuno-chromatography, etc. The methodology of 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 immunochromatography. The sample to be  tested diffuses upward by capillary force at the sample end, and when passing  through the binding pad, cTnI in the sample combines with the colloidal gold mouse  anti-human cTnI monoclonal antibody 1 conjugate to form 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 (test line) coated with mouse anti-human cTnI monoclonal  antibody 2 to form immune complexes of colloidal gold-labeled antibody-antigen-coated antibody. The un-intercepted colloidal gold-labeled complexes continue  to move up, and bind to goat anti-mouse IgG antibody coated on the C line (quality  control line), indicating the completion of the reaction. By visually inspecting the  color development of the detection line under natural light, cTnI in the sample is  qualitatively detected. 

【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 different batch numbers of kits are not interchangeable.