ELISA Assay Kit for Anti-HER-2 h-mAb in Mouse Serum

背景（Background）

How a therapeutic antibody is metabolized in the body is pertinently relevant to its efficacy. Therefore, pharmacokinetics study is an important part of the drug development. HER-2 is probably the most targeted molecule in today’s pharmaceutical industry, thanking to the clinical success of Herceptin®. Many investigational anti-HER-2 mAbs are being developed. There is a growing need for a standard assay that can be used to facilitate the study of their pharmacokinetics.

重构方法（Reconstitution）

See Certificate of Analysis for details of reconstitution instruction and specific concentration.

存储（Storage）

Upon receipt, please store all items at -20°C.

After reconstitution, the stock solution should be kept at -80°C.

原理（Assay Principles）

The enclosed ELISA assay kit for anti-HER-2 h-mAb in mouse serum is based on an enzyme immunoassay (ELISA) between recombinant HER-2 protein (ECD) and a biotinylated anti-HER-2 monoclonal antibody. The method employs the principle of competitive ELISA, allowing quantification of monoclonal anti-HER-2 antibodies in mouse serum.

The assay only involves the following steps:

1. Coat the plate with human HER-2;

2. Add the mixture of your sample and biotinylated anti-HER-2 antibody;

3. Add Streptavidin-HRP followed by TMB or other colorimetric HRP substrate;

4. Record the OD readings and analyze the serum concentration.