Nanjing Synthgene Medical Technology Co., Ltd

【Product Name】 SARS-COV-2 Virus Neutralization Test Kit (Colloidal gold method) 

【Packaging specification】 1/5/25/50 test(s)/kit 

【Intended use】 This product is used for in vitro qualitative detection of novel coronavirus  (SARS-COV-2) neutralizing antibodies in human serum/plasma/whole  blood/fingertip blood. The 2019-nCoV neutralizing antibody is a protective antibody produced by  the human body after being vaccinated with the novel coronavirus vaccine or  infected with the novel coronavirus. Neutralizing antibodies have the function  of recognizing the surface S-RBD protein of the novel coronavirus, blocking  the binding of S-RBD to the cell surface specific receptor (ACE2), and  exerting an antiviral effect. Whether neutralizing antibodies are produced and  the amount or titer produced is an important indicator of the immune  protection effect after vaccination with the novel coronavirus vaccine, and it is  also an important basis for vaccine evaluation and quality control. One of the  important indicators of its cure evaluation, it is helpful for the screening of  novel coronavirus vaccinated population and the judgment of the effect after  vaccination.  

【Testing principle】 This test kit detects the neutralizing antibody of 2019-nCoV by S-RBD double  antigen sandwich method. Take the sample from vaccinated people and drop  it on the sampling area of the test pad, add two drops of diluent, the blood  sample will be chromatographed forward under the capillary action. After  passing the sample pad containing ACE2 and the colloidal gold binding pad  labeled with RBD protein, the sample will enter the nitrocellulose membrane  area. If the sample does not contain neutralizing antibodies, the ACE2 in the  sample pad will bind to the RBD protein in the binding pad, and the detection  line (T line) will not develop color. If the sample contains neutralizing  antibodies, it will block the binding of ACE2 in the sample pad and the RBD  on the colloidal gold binding pad, and the colloidal gold-labeled S-RBD will  be produced on the detection line (T line), and the antibody in the serum will  conjugate with the RBD coated on the detection line (T line), which manifest  as color development of the detection line (T line). The antibody content in the  serum is proportional to the detection line color intensity. After the reaction,  the color development can be directly observed with the naked eye. 

【Main components】

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

2. Sample diluent（1/5/25/50 piece(s)/kit）

3. Disposable plastic straw (1/5/25/50 piece(s)/kit） 

4. Instruction manual (1 copy/kit)