Validation Procedures for Quantification of Food Allergens by Enzyme-Linked Immunosorbent Assay (ELISA)

Methods Mol Biol. 2024:2717:285-304. doi: 10.1007/978-1-0716-3453-0_19.

Abstract

Enzyme-linked immunosorbent assay (ELISA) is a widely used analytical technique for food allergen detection and quantification. Validating ELISA protocols is important for both assay developers and end users as it ensures method reliability. This chapter describes the protocols for validating the sensitivity, specificity, precision, accuracy, robustness, and ruggedness of an ELISA. Example procedures are also provided for sample preparation, allergen extraction, and ELISA operation.

Keywords: Allergen detection; Assay validation; ELISA; Food allergy; Immunoassay.

MeSH terms

  • Biological Assay*
  • Enzyme-Linked Immunosorbent Assay
  • Reproducibility of Results
  • Research Design*
  • Specimen Handling