Nanjing Synthgene Medical Technology Co., Ltd

【PRODUCT NAME】 Syphilis (TP) Antibody 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 for the qualitative detection of Treponema pallidum (TP) antibodies in human whole blood/serum/plasma in vitro. Treponema pallidum is the causative agent of human syphilis, mainly sexually  transmitted. Clinically, it can be manifested as primary syphilis, secondary syphilis,  tertiary syphilis, latent syphilis and congenital syphilis (fetal syphilis). The clinical  manifestations are extremely complex. In the early stage, it mainly invades the skin  and mucous membranes, and in the late stage, it can invade the blood vessels, central  nervous system and various organs of the whole body. Clinically, this product is  mainly used for the auxiliary diagnosis of Treponema pallidum infection. This product  is suitable not only for professional medical personnel to test in medical units, but also  for consumer self-test. The traditional laboratory diagnostic techniques are isolation, culture and identification of viruses. The rapid diagnosis of patients is mainly using chemiluminescence,  immunochromatography and latex methods. 

【TEST PRINCIPLE】 The product adopts the principle of double antigen sandwich. When the sample  contains Treponema pallidum antibody, the Treponema pallidum antibody in the  sample reacts with the syphilis recombinant antigen 1 in the colloidal gold label on the  binding pad to form a labeled antigen-antibody complex, and the complex is chromatographed upward through capillary action, is captured by the detection area (T line)  antigen (recombinant syphilis antigen 2) coated on nitrocellulose membrane, and a red  band appears. The complex continues to be chromatographed upward, and the chicken  IgY in the colloidal gold marker is captured by the quality control area (C line)  antibody (goat anti-chicken IgY antibody) coated on the nitrocellulose membrane, and  a red band appears. When the content of the analyte in the sample is lower than the  minimum detection limit, the detection area (T line) does not develop color.

【MAIN COMPONENT】

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

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

3. Medical waste bag (1 piece/bag, 1/5/10/25/50 piece(s)/kit) 

4. Instruction manual (1 copy/bag, 1 copy/kit) 

Note: The components in the kits of different batch numbers are not interchangeable.