Standardization of negative controls in diagnostic immunohistochemistry: recommendations from the international ad hoc expert panel.
Standardization of negative controls in diagnostic immunohistochemistry: recommendations from the international ad hoc expert panel.
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诊断免疫组织化学阴性对照的标准化：国际特设专家小组的建议。
DOI：
10.1097/pai.0000000000000069
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发表时间：
2014
期刊：
影响因子：
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通讯作者：
InternationalAdHocExpertPanel
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文献类型：
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作者：
Torlakovic,EminaE;Francis,Glenn;Garratt,John;Gilks,Blake;Hyjek,Elizabeth;Ibrahim,Merdol;Miller,Rodney;Nielsen,Søren;Petcu,EugenB;Swanson,PaulE;Taylor,CliveR;Vyberg,Mogens;InternationalAdHocExpertPanel
诊断免疫组织化学(DIHC)需要标准化的阳性对照和阴性对照。IHC阴性对照的使用，无论是哪种类型，虽然已经很好地建立了，但并没有标准化。因此，阴性对照的相关性和适用性继续挑战病理学家和实验室预算。尽管有明确的理论概念，即适当的对照有助于证明DIHC试验的敏感性和特异性，但在日常临床实践中，哪些类型的阳性对照和/或阴性对照适用和/或有用仍不清楚。人们认为有必要为消极控制的使用提供“最佳做法建议”。这种看法不仅是由物流和成本问题驱动的，也是因为对准确的IHC检测的压力增加，特别是当IHC用于预测标记物时，随着个性化药物的不断发展，IHC的数量正在上升。在此，一个国际特设专家小组回顾了与临床实践相关的阴性对照的分类，提出了阴性对照的标准术语，考虑了病理学家可获得的IHC特异性的全部证据，并根据“适合使用”的原则制定了一套在DIHC中使用阴性对照的建议。背景为标准化诊断免疫组织化学(DIHC)，特别是通过建立免疫组织化学的外部质量控制评估(EQA)服务，已经做出了很大努力。英国国家免疫细胞化学和原位杂交外部计划(UK NEQAS ICC&ISH)提供DIHC能力测试和教育已有25年，随后发展了其他几个项目[例如，北欧免疫组织化学质量控制(NordiQC)、美国病理学家学院-外部质量保证/能力测试(CAP-EQA/PT)、加拿大免疫组织化学质量控制(CIQC)、澳大利亚皇家病理学家学院质量保证计划(RCPAQAP)等]。然而，直到最近十年，技术的进步，包括抗体质量的提高、自动化染色平台和高灵敏度的检测系统，才产生了更具重复性的染色方法，这对IHC结果的解释和患者护理产生了直接影响。1-12这些标准化工作源于执业病理学家、国家和国际专业组织以及行业。虽然DIHC的标准化包括分析前、分析和分析后阶段，但本文集中于控制的标准化，特别是阴性对照，而不是总体上的IHC协议的标准化。必须强调的是，DIHC的标准化必须包括控制的标准化，这是质量控制(QC)(分析阶段)的基本要素，以及对IHC结果的解释(分析后阶段)。DIHC的正确解释依赖于对已知阳性和阴性对照所获得的预期染色结果的观察。日常阳性和阴性对照(定义如下)是IHC检测的分析部分和分析后部分之间的重要联系。13本文的重点是DIHC阴性对照的标准化问题。
Standardization of controls, both positive and negative controls, is needed for diagnostic immunohistochemistry (dIHC). The use of IHC-negative controls, irrespective of type, although well established, is not standardized. As such, the relevance and applicability of negative controls continues to challenge both pathologists and laboratory budgets. Despite the clear theoretical notion that appropriate controls serve to demonstrate the sensitivity and specificity of the dIHC test, it remains unclear which types of positive and negative controls are applicable and/or useful in day-to-day clinical practice. There is a perceived need to provide “best practice recommendations” for the use of negative controls. This perception is driven not only by logistics and cost issues, but also by increased pressure for accurate IHC testing, especially when IHC is performed for predictive markers, the number of which is rising as personalized medicine continues to develop. Herein, an international ad hoc expert panel reviews classification of negative controls relevant to clinical practice, proposes standard terminology for negative controls, considers the total evidence of IHC specificity that is available to pathologists, and develops a set of recommendations for the use of negative controls in dIHC based on “fit-for-use” principles.BACKGROUNDGreat efforts have been made to standardize diagnostic immunohistochemistry (dIHC), especially with the establishment of external quality control assessment (EQA) services for immunohistochemistry. The UK National External Scheme for Immunocytochemistry and in situ Hybridization (UK NEQAS ICC & ISH) has been providing proficiency testing and education in dIHC for 25 years, and several other programs have subsequently developed [eg, Nordic immunohistochemical Quality Control (NordiQC), College of American Pathologists-External Quality Assurance/Proficiency Testing (CAP-EQA/PT), Canadian Immunohistochemistry Quality Control (CIQC), Royal College of Pathologists of Australasia Quality Assurance Program (RCPAQAP), and others]. However, it is only in the last decade that technical advances, including improved quality of antibodies (Abs), automated staining platforms, and highly sensitive detection systems have resulted in more reproducible staining methods, which have had a direct impact on interpretation of IHC results and patient care. 1–12 These standardization efforts have originated from practicing pathologists, national and international professional organizations, and industry. Although standardization of dIHC includes preanalytical, analytical, and postanalytical phases, this paper concentrates on the standardization of controls, specifically negative controls, rather than on standardization of IHC protocols overall. It is important to emphasize that the standardization of dIHC must include standardization of controls, which are essential elements of quality control (QC)(analytical phase), as well as interpretation of IHC results (postanalytical phase). The correct interpretation of dIHC is reliant on observation of the expected staining results achieved on known positive and negative controls. Daily positive and negative controls (as defined below) are an important link between analytical and postanalytical components of IHC testing. 13 The focus of this paper is standardization of negative controls for dIHC.