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State of the Art and Science of Immunocytochemistry

Irena Srebotnik Kirbis1

  • 1Institute of Pathology, Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia.

Acta Cytologica
|June 10, 2024
PubMed

Insights

Immunocytochemistry (ICC) quality management is crucial for accurate diagnostic cytopathology. Standardizing best practices, despite inherent complexities, ensures reliable ICC results under new EU regulations.

Area of Science:

  • Cytopathology
  • In Vitro Diagnostics
  • Immunocytochemistry

Background:

  • Immunocytochemistry (ICC) is a common diagnostic tool in cytopathology.
  • Significant variability exists in ICC testing phases, with inadequate quality management.
  • The new EU In Vitro Diagnostic Medical Devices Regulation (IVDR) impacts ICC as a Laboratory-Developed Test (LDT), demanding standardization and validation.

Purpose of the Study:

  • To discuss the challenges of ICC in diagnostic cytopathology.
  • To provide practical insights into ICC standardization and validation.
  • To highlight the importance of quality management for reliable ICC results.

Main Methods:

  • Review of current ICC practices and challenges.
  • Analysis of the impact of the EU IVDR on ICC.
  • Discussion of standardization and validation strategies.

Main Results:

  • Complete standardization of ICC pre-analytical and analytical steps is challenging due to method complexity and evolving reagents/platforms.
  • Improving and standardizing quality management "best practices" is key to achieving high-quality ICC results.
  • The EU IVDR necessitates rigorous standardization, validation, and quality management for ICC.

Conclusions:

  • While full standardization is difficult, robust quality management is essential for accurate and reliable ICC.
  • Key elements of quality management include control slides, optimized protocols, and external quality control participation.
  • Adherence to "best practices" in quality management ensures safe and dependable patient diagnostics using ICC.
Abstract

Keywords:
Control slidesImmunocytochemistryQuality controlQuality managementStandardizationValidation

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