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Automated assay for HER-2/neu in serum
R C Payne1, J W Allard, L Anderson-Mauser
1Lab Testing Segment, Business Group Diagnostics, Bayer Corporation, Tarrytown, NY 10591, USA.
Clinical Chemistry
|February 5, 2000
Summary
This study developed an automated assay for the HER-2/neu protein extracellular domain, crucial for monitoring epithelial cancers. The assay is precise, reliable, and resistant to common interferences.
Area of Science:
- Oncology
- Biochemistry
- Immunology
Background:
- Elevated levels of the HER-2/neu oncogene product's extracellular domain are observed in sera of patients with epithelial cancers.
- Accurate quantification of this domain is essential for cancer patient monitoring.
Purpose of the Study:
- To develop and validate an automated serum assay for quantifying the extracellular domain of the HER-2/neu protein.
Main Methods:
- Utilized a dual monoclonal antibody-based immunoassay with fluorescein and alkaline phosphatase labeling.
- Employed magnetizable particles for separation of bound and free conjugates.
- Measured alkaline phosphatase activity kinetically.
Main Results:
- Demonstrated assay linearity from 0.1 to 250 microg/L with no hook effect up to 10,000 microg/L.
- Achieved high precision with within-run CV of 0.8-1.2% and total CV of 1.1-1.7%.
- Showed minimal cross-reactivity (<0.6%) and resistance to common interfering substances and Herceptin.
Conclusions:
- The automated Bayer Immuno 1(TM) assay for HER-2/neu is precise and robust against interferences.
- These characteristics are vital for the longitudinal monitoring of cancer patients.
- The assay provides reliable quantification of HER-2/neu extracellular domain in serum.