Overview - ISO/TS 23366:2023 (Nanotechnologies)
ISO/TS 23366:2023 specifies minimum requirements for performance evaluation when using fluorescent nanoparticles to quantify biomolecules by immunohistochemistry (IHC). Published by ISO/TC 229 (Nanotechnologies), the technical specification addresses the full quantification workflow - from nanoparticle selection and staining through microscopy, image processing, validation and reporting - to promote reliable, comparable relative quantification results across products and systems.
Key topics and technical requirements
The document outlines practical requirements for performance evaluation, including:
- Selection of fluorescent nanoparticles
- Characteristics to consider (brightness, photostability, aggregation/agglomeration behaviour, quantum yield).
- Quantification system design (section 6)
- Components: antibodies, staining protocols, imaging instrumentation and image processing software.
- Antibody attributes: type, specificity, titre, immunoglobulin class, species applicability.
- Staining and imaging
- Staining conditions, robustness of procedures, light-source adjustment and image quality factors.
- Performance characteristics (section 8)
- Background issues (autofluorescence, nonspecific adsorption, photobleaching), and reference-material dependent indices such as limit of detection (LOD), limit of quantification (LOQ), linearity and dynamic range.
- Comparability and reference materials (section 7)
- Use of calibrated reference material and light-source standardization to achieve comparable results.
- Validation and verification (section 9)
- Single-lab precision, reproducibility and robustness testing before routine use.
- Reporting requirements (section 10)
- Minimum information to document system performance and enable data comparability.
- Informative annexes provide examples for reference material and nanoparticle aggregation/agglomeration evaluation.
Applications and users
ISO/TS 23366:2023 is intended for organizations and professionals involved in quantitative fluorescence IHC using nanoparticles, including:
- Research laboratories performing biomarker quantification
- Clinical and diagnostic laboratories validating quantitative assays
- Biotech and reagent manufacturers developing nanoparticle-labelled IHC kits
- Quality teams and regulatory specialists assessing method performance
Practical uses include method development, product performance claims, inter-lab comparison studies, and establishing standardized reporting for nanoparticle-based IHC assays.
Related standards
While ISO/TS 23366:2023 focuses on nanoparticle-specific performance evaluation, users may also consult existing industry-specific and imaging standards (e.g., terminology and fluorescence measurement guidance) to complement method-specific criteria and regulatory requirements.
Keywords: ISO/TS 23366:2023, fluorescent nanoparticles, immunohistochemistry, performance evaluation, quantifying biomolecules, LOD, LOQ, photobleaching, aggregation, validation.