Anti-SARS-CoV-2 (B.1.617.2) Neutralizing Antibody Titer Serologic Assay Kit (Spike Trimer)

组分（Materials Provided）

产品概述（Product Overview）

It's been reported that coronavirus can infect the human respiratory epithelial cells through interaction with the human ACE2 receptor. The spike protein is a large type I transmembrane protein containing two subunits, S1 and S2. S1 mainly contains a receptor binding domain (RBD), which is responsible for recognizing the cell surface receptor. S2 contains basic elements needed for the membrane fusion.The S protein plays key parts in the induction of neutralizing-antibody and T-cell responses, as well as protective immunity.

应用说明（Application）

This kit is developed for qualitative detection or titer measurement of Anti-SARS-CoV-2 (B.1.617.2) neutralizing antibody (Spike Trimer) in human serum.

It is for research use only.

重构方法（Reconstitution）

Please see Certificate of Analysis for details of reconstitution instruction and specific concentration.

存储（Storage）

2-8℃

原理（Assay Principles）

This assay kit is used to measure the levels of Anti-SARS-CoV-2 neutralizing antibody through a competitive ELISA. The microplate in the kit has been pre-coated with Human ACE2 protein. First serum samples, Positive control, Negative Control are added to the wells followed by addition of HRP-SARS-CoV-2 S protein. After incubation, the wells are washed and substrate is added to the wells. The reaction is terminated by the addition of stop solution and the intensity of color is measured at 450 nm. The presence of neutralizing antibodies in samples will compete with ACE2 for HRP-SARS-CoV-2 S protein binding. The intensity of assay signal decrease proportionally to the presence of Anti-SARS-CoV-2 neutralizing antibody.

Your experiment will include 5 simple steps:

a) All reagents were returned to room temperature(20°C-25°C) before use.

b) Make series the tested sample and control with ditlution buffer, HRP-SARS-CoV-2 Spike protein diluted with dilution buffer.

c) Add the diluted sample, Control and the HRP-SARS-CoV-2 Spike protein add the plate respectively.

d) Wash the plate and add TMB or other colorimetric HRP substrate.

e) Stop the substrate reaction by add diluted acid. Absorbance (OD) is calculated as the absorbance at 450 nm minus the absorbance at 630 nm to remove background prior to statistical analysis. The OD Value reflects the amount of antibody bound.

质量管理控制体系（QMS）

1. 质量管理体系（ISO, GMP）
2. 质量优势
3. 质控流程