Nanjing Synthgene Medical Technology Co., Ltd

【PRODUCT NAME】 HCG Rapid Test Kit (Colloidal gold method) 

【PACKING SPECIFICATIONS】 1 test/bag, 1/5/10/25/50 test(s)/kit  

【INTENDED USE】  This product is used to qualitatively detect human chorionic gonadotropin (HCG) in  human urine in vitro, and is mainly used for auxiliary diagnosis of early pregnancy in  clinical practice. Human chorionic gonadotropin (HCG) is a glycoprotein secreted by placental  trophoblast cells, which is composed of alpha and beta dimerized glycoproteins.  Modern thought that HCG is produced by trophoblast transitional cells and syncytial  cells. Proliferation is rapid in the first 8 weeks of pregnancy to maintain pregnancy.  After about 8 weeks of gestation, HCG gradually declines until it reaches a relatively  stable level at about 20 weeks. The product is used to detect HCG in the urine of  women of pregnancy age, and the result can be quickly obtained in the early stage of  pregnancy, which is an effective means of auxiliary diagnosis. The double-antibody  sandwich immunocolloidal gold chromatography technique is used to achieve the  qualitative detection of human chorionic gonadotropin in human urine in vitro, but it  cannot be used for the detection of trophoblastic tumors. This product is suitable not  only for professional medical personnel to test in medical units. The main detection methods are chemiluminescence and immunochromatography.

【TEST PRINCIPLE】 This product adopts the principle of immunochromatographic double antibody  sandwich method. The test area (T) and the quality control area (C) on the nitrocellulose membrane were respectively coated with mouse anti-human β-HCG monoclonal  antibody 2 and goat anti-mouse IgG polyclonal antibody, and the binding pad contains  colloidal gold mouse anti-human β-HCG monoclonal antibody 1. During the test, the  urine sample is dripped onto the test strip and chromatographed upwards due to the  capillary effect. If it is positive, HCG in the specimen will be combined with the  colloidal gold HCG antibody during the chromatography process, and then continue to  be chromatographed upwards, subsequently the complex will be combined by the  HCG antibody immobilized on the membrane, and a red band will appear in the  detection line area (T). If it is negative, there will be no red band in the test line area  (T). The uncombined colloidal gold HCG antibody complex will bind to goat  anti-mouse IgG, and a red band will appear in the control line area (C). The red band  displayed in the control line area (C) is the standard for judging whether there are  enough samples and whether the chromatography process is normal, and it also serves  as an internal control standard for reagents. 

【MAIN COMPONENT】 1. Test pad, individually packaged in aluminum foil bag (1 piece/bag, 1/5/10/25/50  piece(s)/kit) 2. Instruction manual (1 copy/bag, 1 copy/kit) Note: The components in kits of different batch numbers are non-interchangeable. 

【OPTIONAL COMPONENTS】 □ Medical waste bag (1 piece/bag, 1/5/10/25/50 piece(s)/kit) □ Disposable plastic straw (1 piece/bag, 1/5/10/25/50 piece(s)/kit) □ Urine cup (1 piece/bag, 1/5/10/25/50 piece(s)/kit)