NORTHFIELD, Ill.--(BUSINESS WIRE)--The College of American Pathologists (CAP) updated the “Principles of Analytic Validation of Immunohistochemical Assays” guideline to provide increased precision and accuracy of clinical immunohistochemical assays. This update assesses evidence published since the release of the original guideline in 2014 and provides new recommendations on how to analytically validate/verify immunohistochemical assays used for diagnostic and predictive purposes..

美国病理学家学院（CAP）更新了“免疫组织化学检测分析验证原则”指南，以提高临床免疫组织化学检测的精确度和准确性。本更新评估了自2014年原始指南发布以来发布的证据，并就如何分析验证/验证用于诊断和预测目的的免疫组织化学检测提供了新的建议。。

“This updated guideline provides new and revised recommendations for analytic validation/verification of immunohistochemical assays, which often guide therapeutic decision making for cancer treatment,” explains guideline chair, Jeffrey D. Goldsmith, MD, FCAP. “This guideline update serves to revise validation guidelines for all immunohistochemistry assays with particular focus on predictive markers; major changes to validation of immunohistochemistry assays performed on cytology specimens are also included.”.

“这项更新的指南为免疫组织化学分析的分析验证/验证提供了新的和修订的建议，这些建议通常指导癌症治疗的治疗决策，”FCAP医学博士Jeffrey D.Goldsmith指南主席解释道。“本指南更新旨在修订所有免疫组织化学检测的验证指南，特别关注预测标记；还包括对细胞学标本进行的免疫组织化学检测验证的主要变化。”。

Validation Recommendations

验证建议

While many of the original guideline statements remain similar, there are several new recommendations which provide guidance for validation/verification of IHC assays performed on cytology specimens and predictive marker assays that have distinct scoring systems, such as programmed death receptor-1 (PD-L1)..

虽然许多原始的指南声明仍然相似，但有一些新的建议为验证/验证对细胞学标本进行的IHC检测和具有不同评分系统的预测标记检测（如程序性死亡受体-1（PD-L1））提供了指导。。

For initial analytic validation/verification of every assay used clinically, laboratories should achieve at least 90% overall concordance between the new assay and the comparator assay or expected results. This guideline revision also applies to estrogen receptor (ER), progesterone receptor (PR), and human epidermal growth receptor 2 (HER2) IHC performed on breast carcinoma, also reset at 90% concordance, superseding the previously different concordance thresholds.

对于临床上使用的每种测定的初始分析验证/验证，实验室应在新测定与比较测定或预期结果之间实现至少90%的总体一致性。本指南修订版也适用于对乳腺癌进行的雌激素受体（ER），孕激素受体（PR）和人表皮生长受体2（HER2）IHC，也重置为90%的一致性，取代了以前不同的一致性阈值。

This recommendation harmonizes validation requirements for all immunohistochemical markers..

该建议统一了所有免疫组织化学标记的验证要求。。

“Although the systematic review did not identify substantive new literature, the numerical considerations and modeling discussed in the initial guideline document remains relevant,” states Dr. Goldsmith. “If validation/verification yields unexpected results, the causes should be investigated by the immunohistochemistry medical director.”.

戈德史密斯博士说：“虽然系统评价没有发现实质性的新文献，但最初指南文件中讨论的数值考虑和建模仍然是相关的。”。“如果验证/验证产生意外结果，则应由免疫组织化学医学主任调查原因。”。

Another strong recommendation pertains to predictive marker assays, such as HER2 and PD-L1, in which more than one scoring system is used. The recommendation stipulates separate validation/verifications based on antibody clone/scoring system combination.

另一个强烈的建议涉及预测标记物测定，例如HER2和PD-L1，其中使用了多个评分系统。该建议规定了基于抗体克隆/评分系统组合的单独验证/验证。

Additional specific guidance is offered for validating immunohistochemistry performed on cytology specimens.

为验证在细胞学标本上进行的免疫组织化学提供了额外的具体指导。

These updated recommendations, now available in an early online release in the Archives of Pathology & Laboratory Medicine, were established through the assessment of evidence published since the release of the original guideline in 2014.

这些更新的建议现已在《病理学与检验医学档案》的早期在线版本中发布，是通过评估自2014年原始指南发布以来发布的证据建立的。

Current tools, resources, and information for the Principles of Analytic Validation of Immunohistochemical Assays: Guideline Update can be found on the guideline webpage on cap.org.

关于免疫组织化学分析分析验证原则的当前工具，资源和信息：指南更新可以在cap.org上的指南网页上找到。

About the College of American Pathologists

关于美国病理学家学院

As the world’s largest organization of board-certified pathologists and leading provider of laboratory accreditation and proficiency testing programs, the College of American Pathologists (CAP) serves patients, pathologists, and the public by fostering and advocating excellence in the practice of pathology and laboratory medicine worldwide.

美国病理学家学院（CAP）是世界上最大的经董事会认证的病理学家组织，也是实验室认证和能力验证计划的领先提供商，通过培养和倡导全球病理学和检验医学的卓越实践，为患者、病理学家和公众提供服务。

For more information, visit the CAP Newsroom, CAP.org and yourpathologist.org to watch pathologists at work and see the stories of the patients who trust them with their care..

有关更多信息，请访问CAP新闻编辑室、CAP.org和yourpathologist.org，观看病理学家的工作，并了解信任他们的患者的故事。。