Lateral Flow Immunoassays

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