Overview
EN ISO 21572:2019 - Foodstuffs: Molecular biomarker analysis - Immunochemical methods for the detection and quantification of proteins - specifies performance criteria and analytical considerations for immunochemical assays used to detect and/or quantify a specific protein or proteins of interest (POI) in defined food or biological matrices. Adopted by CEN in October 2019 (superseding EN ISO 21572:2013), the standard focuses on immunochemical protein-detection approaches such as ELISA and lateral flow devices and provides guidance on sample preparation, extraction, assay performance and result reporting.
Key topics and requirements
- Scope and principle: Defines applicability to a wide range of sample types and POIs, emphasizing immunochemical binding (antibody capture + detection signal).
- Sample handling and extraction: Selection of appropriate extraction buffers and procedures to maximize extraction efficiency and analyte stability without interfering with assays.
- Assay procedure and calibration: Preparation of calibration curves, positive controls and reference materials; guidance for both quantitative and qualitative formats.
- Performance parameters: Validation and routine-check criteria including accuracy, precision, sensitivity, selectivity, limits of detection (LOD) and limits of quantification (LOQ).
- Matrix and method effects: Considerations for matrix effects, parallelism/linearity, hook effect, selectivity and assay applicability to specific matrices.
- Interpretation and reporting: Standardized expression of qualitative, semi-quantitative and quantitative results and required elements for test reports.
- Annexes with examples: Informative Annex A (ELISA) and Annex B (lateral flow devices) provide example procedures and practical assay setups.
Practical applications
EN ISO 21572:2019 is designed for use in:
- Food safety testing (allergenic proteins, contamination monitoring)
- Crop and food production analysis (novel or expressed proteins in biotech crops)
- Food processing and marketing verification
- Biotechnology and disease indexing where protein biomarkers are relevant
- Method development and validation in analytical laboratories
The standard helps ensure reliable immunochemical protein detection across matrices, supports comparability of results, and provides a framework for method validation and routine quality control.
Who should use it
- Food and feed testing laboratories
- Regulatory agencies and enforcement laboratories
- Food industry quality and R&D teams
- Biotechnology and academic researchers developing immunoassays
- Manufacturers of ELISA kits and lateral flow devices seeking standardized performance criteria
Related standards
- ISO 16577 (terms for molecular biomarker analysis) is referenced for terminology and context.
- The document aligns with broader ISO/CEN guidance on food analysis and method validation.
Keywords: EN ISO 21572:2019, immunochemical methods, ELISA, lateral flow device, protein detection, molecular biomarker analysis, foodstuffs, assay validation, limits of detection, matrix effects.