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.
CONCLUSIONS: 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.
CONCLUSIONS: 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.
CONCLUSIONS: 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.
CONCLUSIONS: 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.
摘要：
免疫细胞化学（ICC）是诊断性细胞病理学中广泛可用且广泛使用的辅助方法，在所有测试阶段都具有很大的变异性，并且适当的质量管理水平较低。现在，随着新的欧洲（EU）体外诊断医疗器械法规（IVDR）的引入，非标准化的ICC格局受到了挑战。根据这个条例,细胞切片上的ICC属于实验室开发测试（LDT）类别，这需要严格的标准化，验证,全面的质量管理。由于方法的复杂性和不断发展的抗体，不可能完全标准化ICC中的分析前和分析步骤。检测系统,和平台。然而,类似于免疫组织化学(IHC)的方法，改进和规范质量管理中的“最佳实践”将导致高质量，正确,准确,和可靠的ICC结果。以与患者样品相同的方式制备的对照载玻片，优化的ICC协议和参与ICC的外部质量控制是良好质量管理的支柱，对于确保安全可靠的患者诊断至关重要。在这次审查中,将讨论当前免疫细胞化学（ICC）在诊断细胞病理学中的挑战，以及对ICC标准化和验证的实际见解。
