Contract Assay Development
Creative Diagnostics is experienced in providing a wide range of immunoassay development services.
Based on our unparalleled expertise in developing highly specific diagnostic antibodies used in Sandwich ELISA kits, Competitive ELISA kits and Colloidal gold immuno-chromatography strips, we have made a large number of diagnostic kits for quantitative detection of enzymes, proteins, peptides, antibodies, receptors, small molecules,metabolites and drug derivatives from biological samples, including cell culture supernatant, cell lysate, tissue homogenate, serum, plasma, ascites, cerebrospinal fluid and urine, that are collected from preclinical animal studies and clinical human studies.
We have established proprietary antibody screening and recombinant protein standards manufacturing methods that are tailored for immunoassay development. Our staff scientists follow rigorous guidelines for quality control with a focus on thorough optimization and validation of every aspect of assay development, including antibody specificity, assay sensitivity, reproducibility (intra- and inter-assay), cross-reactivity, standard curve range, assay accuracy (linearity and recovery) and kit stability.
Our service expertise covers cardiovascular diseases, oncology, inflammatory and autoimmune diseases, infectious diseases and psychiatric disorders. Of note, we provide assay development services for multiple types of biomarkers, including proteins, nucleic acids, carbohydrates and lipids. We can also build up diagnostic kits that are intended for analysis of enzyme activity, protein-protein interaction, nucleic acid-protein interaction and inhibitor characterization.
Featured Immunoassay Development Services:
We would appreciate the opportunity to learn your specific needs and discuss how our custom immunoassay development services could contribute to your research.
Assay format supported:
- Lateral Flow and Flow Through
- ELISA
- Colloidal gold
- Fluorescent and Visual latex
- Qualitative (yes/no) assays
- Semi quantitative assays
- Fully quantitative assays
Pipeline:
- Phase 1: Feasibility Study
A development plan to conduct a feasibility study will be prepared based on the specifications. At the end of the feasibility study a report will be prepared and submitted along with a small number of early prototype tests.
- Phase 2: Optimization
A robust and reproducible test that fulfils the customer specification will be produced. A wide range of materials including membranes, coating buffers, conjugation parameters, buffer release pads and sample pads are evaluated using proven protocols.
- Phase 3: Validation
The validation stage involves the preparation and submission of a validation plan and the manufacture of three independent lots using different batches of critical materials. Prior to the validation batches, draft Application Notes will be prepared and used to conduct the three batch validation.
- Phase 4: Commercialization
We provide successful manufacture of multiple test lots within established specifications according to approved documentation. We provide transfer of test production to manufacturing & summary report.
Creative Diagnostics is committed to quality and customer satisfaction. A dedicated project manager will be assigned to each project to interact with the customer to meet his specific requirements.