Sample Proposal 3

Required materials and reagents to begin assay development:
1.Analyte.
2.Antibodies.
3.Analyte negative samples.
4.Analyte positive samples.

Step I: Reagent Preparation and Initial Assay Titration
1.Selection of compatible monoclonal antibodies and labeled analyte.
2.Titration of capture antibody and labeled analyte to working dilutions.
3.Development and optimization of ELISA plate coating procedures for optimal antigen capture and competitive inhibition of labeled antigen binding to the plate-bound capture antibody.

Step II: Assay Optimization
1.Selection of proper diluents for sample and conjugate signal generation.
2.Development of a functional assay protocol within the target sensitivity range of the analyte.
3.Construction of a functional standard curve to mimic performance characteristics of the sample matrix.

Step III: Assay Validation
1.Definition and documentation of assay performance characteristics essential for optimal assay utility (such as sensitivity and precision).
2.Documentation of diluent performance parameters to assure proper matrix composition (such as recovery and linearity).
3.Fine-tuning of specific assay components and incubation protocols to meet final performance requirements.

Step IV: Packaging of Final Test Kit Product
1.Quality control assessment of final kit components.
2.Final assembly, packaging, and delivery of components for 25 immunoassay kits.

Total Assay Development Cost: range of $10,000 - $15,000
Estimated Time: 21-27 weeks