EN ISO 21572:2019 PDF

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.