Overview
ISO 22942-1:2022 specifies general requirements for development, validation and routine use of nucleic acid analytical methods based on isothermal polymerase chain reaction (isoPCR). Applicable to food, feed, plant matrices and propagules, plant pathogens and animals, the standard defines principles, laboratory practices, performance criteria and reporting expectations for isoPCR workflows. It also provides technology-specific guidance (LAMP, RCA, RPA, HDA, SDA, NASBA, Cas9nAR) in informative annexes.
Key topics and technical requirements
- Principle and scope: Defines isoPCR as constant-temperature enzymatic amplification methods that can operate without precision thermal cycling.
- Method development: Requirements for intended purpose, scientific rationale, units of measurement and documentation (including Minimum Information for an isoPCR Experiment - MIIPCRE).
- Validation and performance criteria: Structured validation covering sensitivity, limit of detection (LOD), limit of quantification (LOQ), linearity, range, precision, accuracy, selectivity/specificity, robustness and applicability to target matrices.
- Nucleic acid quality: Guidance on extraction, sample preparation and assessment of extract quality for reliable amplification.
- Controls and contamination management: Use of environmental, positive, negative and extraction controls; workspace design and procedural segregation to reduce false positives/negatives.
- Interpretation and reporting: Criteria for interpreting assay controls, expression of negative/positive/quantitative/ambiguous results, and required content for test reports.
- Annexed methods: Informative examples and protocol-level guidance for LAMP, RCA, HDA, RPA, SDA, NASBA and Cas9nAR to support practical implementation.
Applications and who should use it
ISO 22942-1:2022 is designed for:
- Diagnostic and regulatory laboratories performing molecular biomarker analysis in food safety, plant health and veterinary contexts.
- Test developers and kit manufacturers creating isoPCR-based assays (LAMP, RPA, etc.).
- Accreditation bodies, quality managers and scientists implementing method validation, establishing LOD/LOQ, and producing compliant test reports.
- Field-deployable testing programs where rapid, low-instrumentation nucleic acid detection is required (e.g., on-site plant pathogen screening, food authenticity checks).
Practical value: enables consistent, validated isoPCR workflows that reduce false results, streamline reporting and facilitate regulatory acceptance for food/feed and plant/animal testing.
Related standards
- Other parts of the ISO 22942 series (technology- or application-specific parts).
- Relevant laboratory and accreditation guidance such as ISO/IEC 17025 for testing laboratory competence and quality systems.
Keywords: ISO 22942-1:2022, isoPCR, isothermal PCR, LAMP, RPA, method validation, limit of detection, molecular biomarker analysis, food testing, plant pathogen detection.
Open preview (PDF)Molecular biomarker analysis — Isothermal polymerase chain reaction (isoPCR) methods — Part 1: General requirements
