Nanjing Synthgene Medical Technology Co., Ltd

【Product name】 D-Dimer 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 D-dimer in human  plasma and whole blood. D-dimer is a specific marker produced after fibrin is degraded. The increase in its  content represents the frequent occurrence of fibrinolysis in the human body and  predicts the prethrombotic state, thrombosis or secondary fibrinolysis. Increased or  positive D-dimer content is seen in secondary fibrinolytic hyperfunction, such as  hypercoagulable state, diffuse intravascular coagulation, kidney disease, organ  transplant rejection, and thrombolytic therapy, etc.; in addition, myocardial  infarction, cerebral infarction , pulmonary embolism, venous thrombosis, infection  and tissue necrosis can all lead to elevated D-dimer; D-dimer is a key indicator for  deep vein thrombosis (DVT), pulmonary embolism (PE), diffuse intravascular  coagulation (DIC). Currently, clinical and laboratory methods for detecting D-dimer include immunoturbidimetric method, chemiluminescence method, fluorescence immunochromatography, etc. The method 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 upwards by capillary force at the sample end, and when passing  through the binding pad, D-dimer in the sample combines with the colloidal gold-labeled mouse anti-human D-dimer monoclonal antibody 1 conjugate to form  colloidal gold-labeled antibody-antigen complexes; the colloidal gold-labeled  antibody-antigen complexes continue to diffuse to the nitrocellulose membrane  with the sample, and is intercepted by the T line (detection line) coated with mouse  anti-human D-dimer monoclonal antibody 2 to form immune complexes of  colloidal gold-labeled antibody-antigen-coated antibody. The non-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. By visually inspecting the color development of the  detection line under natural light, the D-dimer 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 non-interchangeable.