Catalog No.
KDC09602
Description
PRINCIPLE OF THE ASSAY This assay employs the quantitative competitive enzyme immunoassay technique. Recombinant Human CD340 has been pre-coated onto a microplate. Standards or samples are premixed with biotin-labeled antibody and then pipetted into the wells. Pertuzumab in the sample competitively binds to the pre-coated protein with biotin-labeled Pertuzumab. After washing away any unbound substances, Streptavidin-HRP is added to the wells. Following a wash to remove any unbound enzyme reagent, a substrate solution is added to the wells and color develops in inversely proportion to the amount of Pertuzumab bound in the initial step. The color development is stopped and the intensity of the color is measured.
Applications
Used for the quantitative determination of Pertuzumab concentration in serum and plasma.
Detection method
Colorimetric
Sample type
Plasma, Serum
Assay type
Quantitative
Range
93.75 - 6,000 ng/mL
Sensitivity
26.04 ng/mL
Precision
Intra-Assay Precision (Precision within an assay): <20%
Three samples of known concentration were tested sixteen times on one plate to assess intra-assay precision.
Inter-Assay Precision (Precision between assays): <20%
Three samples of known concentration were tested in twenty four separate assays to assess inter-assay precision.
| Intra-Assay Precision | Inter-Assay Precision |
Sample | 1 | 2 | 3 | 1 | 2 | 3 |
n | 16 | 16 | 16 | 24 | 24 | 24 |
Mean (ng/mL) | 3,894.6 | 864.4 | 193.5 | 3,865.5 | 892.3 | 212.4 |
Standard deviation | 232.9 | 60.4 | 17.1 | 377.5 | 60.2 | 9.6 |
CV (%) | 6.0 | 7.0 | 8.8 | 9.8 | 6.7 | 4.5 |
Recovery
80-120%
Shipping
2-8 ℃
Stability and Storage
When the kit was stored at the recommended temperature for 6 months, the signal intensity decreased by less than 20%.
Alternative Names
OMNITARG, rhuMAB 2C4, CAS: 380610-27-5
Background
Pertuzumab (also called 2C4, trade name Perjeta) is a humanized (from mouse) monoclonal antibody (mAb) used in combination with trastuzumab and docetaxel for the treatment of metastatic human epidermal growth factor receptor 2 (HER2)-positive breast cancer; it also used in the same combination as a neoadjuvant in early HER2-positive breast cancer. It was discovered and developed by Genentech, a subsidiary of Roche, and was first approved in 2012. It is manufactured recombinantly in Chinese hamster ovary (CHO) cells. The monoclonal antibody 2C4 appears to have first been published in 1990 by scientists from Genentech. By 2003 Genentech understood that 2C4 prevented HER2 dimerizing with other HER receptors and had begun Phase I trials, aiming for a broad range of cancers, not just one’s overexpressing HER2. It was the first known HER dimerization inhibitor. In 2005 Genentech presented poor results of Phase II trials of pertuzumab as a single agent in prostate, breast, and ovarian cancers, and said that it intended to continue developing it in combination with other drugs for ovarian cancer. In 2007 Genentech dropped the trade name Omnitarg. In 2012 the results were published of the CLEOPATRA trial, a randomized placebo-controlled Phase III trial of pertuzumab in combination with trastuzumab and docetaxel in HER2-positive metastatic breast cancer. Pertuzumab received US Food and Drug Administration (FDA) approval for the treatment of HER2-positive metastatic breast cancer later that year. The FDA approved the neoadjuvant indication in 2013. Pertuzumab was approved in Europe in 2013.
