ISO 20813:2019

Overview

ISO 20813:2019 - "Molecular biomarker analysis - Methods of analysis for the detection and identification of animal species in foods and food products (nucleic acid‑based methods) - General requirements and definitions" - sets minimum performance and reporting requirements for DNA‑based molecular methods used to detect, identify and quantify animal species in food. The standard covers conventional PCR, real‑time PCR, probe‑based assays, post‑PCR detection methods and combinations thereof, and applies to mammals, birds, reptiles, amphibians, fishes, molluscs, crustaceans and insects (see Annex A).

Key topics and technical requirements

• Performance characteristics: Defines minimum expectations for method performance, including specificity, sensitivity, limit of detection (LOD), limit of quantification (LOQ), dynamic range, precision and trueness.
• Specificity testing: Requires both in silico (bioinformatics) and experimental assessment of inclusivity (target species detection) and exclusivity (non‑target discrimination). Tools like BLAST are referenced for sequence checks.
• Sensitivity and quantification: Distinguishes qualitative presence/absence from quantitative results expressed as DNA copy number ratios (c/c) and discusses limitations when converting DNA copy ratios to mass/mass ratios.
• Applicability considerations: Addresses target location (nuclear vs mitochondrial), copy number per cell, target length, matrix effects and processing‑related DNA degradation. Recommends DNA extraction from multiple representative matrices.
• Validation: Specifies requirements for single‑laboratory validation and interlaboratory (collaborative) studies to establish method robustness, reproducibility and fitness for purpose.
• Laboratory practices: Covers facilities, equipment, sample preparation, controls, data analysis, expression of positive/negative/quantitative results, and test reporting.
• Annexes: Informative lists of typical species for testing (Annex A) and examples for converting DNA copy numbers to mass ratios (Annex B).

Applications and users

ISO 20813 is essential for organizations that implement or evaluate nucleic acid‑based animal species testing in food safety, authenticity and regulatory compliance contexts:

• Food testing laboratories and contract analytical services
• Method developers and assay manufacturers (PCR kits, probes, platforms)
• Regulatory agencies and inspection bodies performing species verification
• Research laboratories focused on food fraud, allergen/source tracing and supply‑chain verification

The standard supports reliable species identification in processed foods, ingredient verification, halal/halal authentication, allergen/source control and legal compliance.

Related standards

• ISO 16577 - Molecular biomarker analysis - Terms and definitions
• ISO 24276 - Detection of genetically modified organisms - General requirements and definitions

Keywords: ISO 20813, molecular biomarker analysis, PCR, real‑time PCR, DNA detection, species identification in food, method validation, LOD, LOQ, specificity, inclusivity, exclusivity, food authenticity.