State of the Art and Science of Immunocytochemistry.

IF 1.6 4区医学 Q3 PATHOLOGY Acta Cytologica Pub Date : 2024-06-10 DOI:10.1159/000539634

Irena Srebotnik Kirbis

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Abstract

Background: Immunocytochemistry (ICC) is a widely available and extensively used ancillary method in diagnostic cytopathology with great variability in all test phases and a low level of adequate quality management. The non-standardized ICC landscape is now challenged with the introduction of the new European (EU) In Vitro Diagnostic Medical Devices Regulation (IVDR). According to this regulation, ICC on cytological slides falls under the category of Laboratory-Developed Tests (LDT), which requires rigorous standardization, validation, and thorough quality management.

Summary: Complete standardization of pre-analytical and analytical steps in ICC is impossible due to the complexity of the method and the constantly evolving antibodies, detection systems, and platforms. However, similar to the approach in immunohistochemistry, improving and standardizing "best practices" in quality management will result in high-quality, correct, accurate, and reliable ICC results. In this review, the current challenges of ICC in diagnostic cytopathology will be discussed, along with practical insights into ICC standardization and validation.

Key messages: Control slides prepared in the same manner as the patient samples, optimized ICC protocols, and participation in external quality control for ICC are the pillars of good quality management and essential to ensure safe and reliable patient diagnostics.

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免疫细胞化学的艺术与科学现状。

免疫细胞化学（ICC）是细胞病理学诊断中一种广泛使用的辅助方法，但在所有检测阶段都存在很大差异，而且质量管理水平较低。随着新的《欧洲（欧盟）体外诊断医疗器械法规》（IVDR）的出台，非标准化的 ICC 现状受到了挑战。根据该法规，细胞切片上的 ICC 属于实验室开发检验（LDT）范畴，需要严格的标准化、验证和全面的质量管理。由于 ICC 方法的复杂性以及抗体、检测系统和平台的不断发展，ICC 分析前和分析步骤不可能完全标准化。不过，与免疫组化（IHC）的方法类似，改进质量管理并实现 "最佳实践 "的标准化将带来高质量、正确、准确和可靠的 ICC 结果。以与患者样本相同的方式制备对照切片、优化 ICC 方案以及参与 ICC 外部质量控制是良好质量管理的支柱，也是确保患者诊断安全可靠的关键。本综述将讨论免疫细胞化学（ICC）目前在细胞病理学诊断中面临的挑战，以及对 ICC 标准化和验证的实用见解。

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来源期刊

Acta Cytologica 生物-病理学

CiteScore

3.70

自引率

11.10%

发文量

审稿时长

4-8 weeks

期刊介绍： With articles offering an excellent balance between clinical cytology and cytopathology, ''Acta Cytologica'' fosters the understanding of the pathogenetic mechanisms behind cytomorphology and thus facilitates the translation of frontline research into clinical practice. As the official journal of the International Academy of Cytology and affiliated to over 50 national cytology societies around the world, ''Acta Cytologica'' evaluates new and existing diagnostic applications of scientific advances as well as their clinical correlations. Original papers, review articles, meta-analyses, novel insights from clinical practice, and letters to the editor cover topics from diagnostic cytopathology, gynecologic and non-gynecologic cytopathology to fine needle aspiration, molecular techniques and their diagnostic applications. As the perfect reference for practical use, ''Acta Cytologica'' addresses a multidisciplinary audience practicing clinical cytopathology, cell biology, oncology, interventional radiology, otorhinolaryngology, gastroenterology, urology, pulmonology and preventive medicine.