Lateral Flow Immunoassays
Development and production of Lateral Flow kits under customer demand. Through Lateral Flow Service, you will have access to a cost-effective final Immunoassay product that eactly meet your requirements: limit of detection, diagnostic and analytical specificity and sensitivity, reproducibility (inter-lot, inter-day, inter-lab), and quality control definition.
Experimental procedure consists in the optimization of different input variables that affect directly the quality of the final product, defined by output variables:
1- Immunoassay Definition
- Type of immunoassay (sandwich, competitive assay, etc)
- Type of microparticle (latex, cellulose, etc)
- Matrix sample (sera, stool, urine, food, tissue)
- Membrane selection (flow rate, pore size, surface)
2- Reagent and Material Selection
- Control and test line reagents (type and concentration)
- Type of microparticle (size, colour)
- Microparticle derivatization procedure
- Membrane, conjugate and absorbent pads
- Buffer: components and pH
3- Sample Incubation
- Positive and Negative Controls
- Sample diluent design (components and pH)
4- Product Characterization
- Inter and intra (lot, assay, lab and user) reproducibility
- Cut-off definition (ROC curve analysis)
- Sample analysis, diagnostic and analytical specificity and sensibility
- Stability studies
5- Immunoassay Production