Development and validation of multiplexed immunoassays is a core competence at RBM. Commercially available antigens and antibodies are screened for their suitability. If none are found, the necessary antigen and antibody development is outsourced to one of several reliable vendors. All Multi-Analyte Profiles (MAPs) are developed and validated using a standard procedure based upon the simple principles of immunoassay. Each assay is first developed as a single test to achieve the sensitivity and dynamic range necessary for that particular analyte. The resulting assay is then incorporated into a multiplex. At some point during multiplex development, the size of the multiplex is optimized to between 10 and 100 analytes. Multiplexed calibrators (8 levels per analyte) and controls (3 levels per analyte) are developed. Validation of the multiplex is completed and no additional changes or additions are made to that set of tests without repeating validation. Validation parameters that are determined for each multiplexed analyte assay include:
- Least detectable dose (LDD)
- Lower assay limit (LAL)
- Normal range
- Dynamic range
- Imprecision
- Spiked recovery
- Parallelism
- Correlation (where possible)
- Cross-reactivities
- Matrix interferences
Contact your sales representative or RBM directly at info@rbmmaps.com.
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Rules-Based Medicine, Inc. | 3300 Duval Road • Austin, TX 78759 • T: 866-RBM-MAPS • F: 512-835-4687 • E: info@rbmmaps.com |