BS EN ISO 20166-2:2018

Overview

BS EN ISO 20166-2:2018 establishes critical specifications for pre-examination processes of formalin-fixed and paraffin-embedded (FFPE) tissue when isolating proteins for molecular in vitro diagnostic examinations. This standard provides essential guidance for laboratories conducting protein-based molecular diagnostics, ensuring consistent and reliable results in clinical testing environments.

The standard addresses the unique challenges associated with protein extraction from FFPE tissue samples, which are widely used in histopathology and molecular pathology laboratories. By standardising pre-examination procedures, this document helps laboratories maintain specimen integrity and optimise downstream analytical processes.

Key Requirements

The standard specifies comprehensive requirements for handling FFPE tissue samples during protein isolation procedures. Key areas covered include:

• Sample identification and documentation protocols throughout the pre-examination process
• Storage conditions and temperature requirements for FFPE tissue blocks and sections
• Sectioning procedures and thickness specifications for optimal protein recovery
• Deparaffinisation methods and solvent selection criteria
• Protein extraction protocols and buffer system requirements
• Quality control measures for assessing protein integrity and concentration
• Documentation requirements for traceability and audit purposes

The standard emphasises the importance of maintaining sample integrity from initial processing through to final analysis, recognising that pre-examination variables significantly impact diagnostic accuracy.

Implementation Benefits

Laboratories implementing BS EN ISO 20166-2:2018 gain several operational advantages. The standardised approach reduces variability between different operators and testing sessions, leading to more consistent diagnostic results. This consistency is particularly valuable in clinical settings where diagnostic accuracy directly impacts patient care decisions.

The standard's systematic approach to pre-examination processes helps laboratories identify and control critical variables that could affect protein analysis outcomes. By following established protocols, laboratories can minimise the risk of pre-analytical errors that might compromise test results or require sample re-processing.

Implementation also supports laboratory accreditation requirements, providing documented evidence of standardised procedures that meet international best practices. This documentation proves valuable during external audits and quality assessments.

Quality Assurance Framework

The standard establishes a robust quality assurance framework for protein isolation from FFPE tissues. This includes specific requirements for:

• Equipment calibration and maintenance procedures
• Reagent qualification and storage protocols
• Environmental monitoring and control measures
• Staff competency assessment and training requirements
• Internal quality control procedures and acceptance criteria

These quality measures help laboratories maintain consistent performance and identify potential issues before they impact diagnostic testing.

Compliance Value

BS EN ISO 20166-2:2018 supports compliance with broader quality management requirements in medical laboratories. The standard aligns with ISO 15189 requirements for medical laboratories, providing specific technical guidance for molecular diagnostic applications.

For laboratories seeking accreditation or maintaining existing accreditation, this standard demonstrates commitment to international best practices in pre-examination processes. The documented procedures and quality controls specified in the standard provide auditable evidence of systematic approach to quality management.

Regulatory compliance benefits extend to meeting requirements for clinical trial laboratories and research institutions conducting molecular diagnostic studies. The standardised approach supports data integrity requirements and helps ensure reproducibility of results across different testing sites.

Technical Applications

The standard applies to various molecular diagnostic applications including biomarker analysis, companion diagnostics, and research applications requiring protein analysis from archived tissue samples. Common applications include oncology diagnostics, where protein expression analysis guides treatment decisions.

Laboratories conducting immunohistochemistry, Western blotting, or mass spectrometry-based protein analysis from FFPE tissues will find this standard particularly relevant. The pre-examination specifications help optimise sample preparation for these downstream analytical techniques.