Put the World's Leader in Cytokine Immunoassays to Work For You
The Quantikine family of cytokine immunoassays has earned the trust of researchers worldwide. Our development, manufacturing, and quality control systems ensure large-scale production of specific, sensitive, accurate assays with unparalleled reproducibility from plate-to-plate and from lot-to-lot. Now, with R&D Systems' Custom Assay Development & Manufacturing services, you can put these same systems to work for you. Whether you're starting from scratch or require large-scale production of a working assay, we have the expertise and capacity to meet the needs of your organization.
Assay Formats
- Quantikine® - Our standard top-selling colormetric sandwich ELISA format.
- QuantiGlo® - Chemiluminescent sandwich ELISA format offering increased sensitivity and dynamic range.
- Quantikine IVD® - Immunoassays for in vitro diagnostic use.
- Fluorokine E® - Fluorometric captured-enzyme activity assays for enzymatic analytes.
- Fluorokine® MAP (FMAP) - MultiAnalyte Profiling using the Luminex® 100™ platform.
The Assay Development Process
Phase 1 - Rough Assay Development
- Establish design goals
- Inventory and screen available reagents.
- Develop components of the rough assay.
- Assess stability of rough assay components.
- Assess performance characteristics of the rough assay.
- Generate written rough assay protocol
- Produce written feasibility report summarizing development.
Phase 2 - Optimize Assay
- Confirm design goals.
- Optimize assay components & design to improve performance characteristics.
- Write standard operating procedures (SOPs) for component and assay manufacture.
- Produce written design review.
Phase 3 - Validation, Scale-Up and Transfer to Manufacturing
- Transfer sops from development to manufacturing.
- Manufacture two validation batches of product. Execute validation studies based on performance parameters.
- Execute stability studies on manufactured kit components.
- Establish finished product release specifications for quality control department.
- Generate written validation report.
Phase 4 - Manufacture and Supply of Finished Product
- Manufacture, QC, and delivery of custom kits.
- Ongoing maintenance of manufacturing and QC records.
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Luminex 100 is a trademark of Luminex Corporation |