Anti-SARS-CoV-2 Neutralizing Antibody Quantitative Detection Kit (Spike RBD)

组分（Materials Provided）

产品概述（Product Overview）

The newly identified Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) poses continual threat to human health due to rapid transmission worldwide.Anti-SARS-CoV-2 Neutralizing Antibody Quantitative Detection Kit (Spike RBD)to test the protective neutralizing antibody levels in post-vaccination serum or convalescent serum.

应用说明（Application）

This kit is developed for quantitative detection of Anti-SARS-CoV-2 neutralizing antibody in human serum. It is intended for research use only (RUO).

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）

1. Unopened kit should be stored at 2℃-8℃ upon receiving.

2. Find the expiration date on the outside packaging and do not use reagents past their expiration date.

3. The opened kit should be stored per components table. The shelf life is 30 days from the date of opening.

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 samples and Calibrator are added to the wells followed by addition of HRP-SARS-CoV-2 Spike RBD. 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 Spike RBD 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) The tested sample with ditlution buffer.

c) Add the HRP-SARS-CoV-2 RBD, diluted sample and Calibrator 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 calculate 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 protein 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