Custom antibody development and validation for food allergen lateral flow assays

Overview

This offering covers the development, characterization, and validation of high-performance antibodies specifically designed for lateral flow assay (LFA) detection of food allergens. The core challenge in LFA is the limited interaction time between capture antibodies, detection antibodies, and target analytes as the sample flows by capillarity. To overcome this, antibodies with high affinity (KD < nM) and high specificity (>90%) are essential for reliable, sensitive detection of allergenic food proteins.

The solution targets food safety applications, including the detection of traces from almonds, peanuts, hazelnuts, soy, sesame, pout, and shrimp in commercial food products. Two antibody pairs have already been validated for multiplexed detection of almond and peanut allergens, achieving detection limits of 185 and 229 µg/kg respectively, with 77% selectivity and 5–25% relative standard deviation (RSD) accuracy. The offering also extends to allergy diagnostics, with validated nanobody calibrators for antibiotic allergy diagnosis.

Technical specifications

Antibody development platforms:

• Polyclonal antibodies developed through rabbit immunization with recombinant allergenic proteins, followed by affinity chromatography isolation
• Monoclonal antibodies via hybridoma technology
• Single-domain antibodies (nanobodies) for compact, stable detection reagents
• Synthetic antibodies via phage display technology, previously applied for allergy diagnosis reference materials

Validated performance characteristics:

• Sensitivity: detection limits of 185 µg/kg (almond) and 229 µg/kg (peanut) in multiplexed LFA format
• Selectivity: 77% in commercial food matrix analysis
• Accuracy: RSD range of 5–25%

Characterization and validation capabilities:

• Surface plasmon resonance (SPR) analysis for affinity determination
• ELISA titrations and checkerboard assays
• Cross-reactivity and stability assays
• Western blot analysis
• Analytical characterization of antibody performance in LFA format
• Cross-validation against commercial ELISA kits

Technology readiness level

The antibody pairs for almond and peanut multiplexed LFA detection have been fully validated in commercial allergen-suspicious food consumables and are ready for licensing or further co-development. Additional antibodies against hazelnut, soy, sesame, pout, and shrimp allergens are currently under validation in lateral flow assay format. The team has also demonstrated capability in developing nanobody calibrators and synthetic IgE reference materials for allergy diagnosis. Depending on partner needs, the offering includes both licensing of already-developed antibodies and collaborative development of new antibodies for additional allergens, with full characterization and LFA validation included.