Laboratories worldwide find it challenging to identify enough tissues and cases for verification and validation studies of low-incidence, rare antigens. These antigens have a low frequency of occurrence in the population, or have little or no expression in normal tissues. Validation studies are essential to assure testing standardization before introducing a new instrument, product, or test into the clinical laboratory. The College of American Pathologists has published comprehensive guidelines for the verification and validation of new immunohistochemical tests introduced into the laboratory menu. Within the guidelines, varied numbers of cases are required for nonpredictive versus predictive markers. However, regarding low-incidence antigens, the laboratory medical director determines the extent of validation required. Recommended practical solutions available to clinical laboratories for low-incidence validation include developing internal resources using the laboratory information system with retrospective and prospective search(s) of archival material and purchase of tissue microarray blocks, slides, or cell lines from external resources. Utilization of homemade multitissue blocks has proved to be extremely valuable in biomarker research and demonstrated great utility in clinical immunohistochemistry laboratories. Participation in External Quality Assessment program(s) may provide insufficient numbers or the ability to calculate concordance rates. However, supplementation with in-house tissues can allow a laboratory to reach the optimal number of cases needed for verification and/or validation schemes. An alternative approach is conducting a thorough literature search and correlating staining patterns of the new test to the expected results. These solutions may be used uniquely or together to assure consistent standardized testing.

中文翻译：

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发生频率较低的稀有组织和抗原的免疫组织化学验证

世界各地的实验室发现识别足够的组织和病例以进行低发生率稀有抗原的验证和验证研究具有挑战性。这些抗原在人群中出现的频率较低，或者在正常组织中很少或没有表达。在将新仪器、产品或测试引入临床实验室之前，验证研究对于确保测试标准化至关重要。美国病理学家学会发布了用于验证和确认实验室菜单中引入的新免疫组织化学检测的综合指南。在指南中，非预测性标记与预测性标记需要不同数量的病例。然而，对于低发生率抗原，实验室医学主任确​​定所需验证的程度。建议临床实验室用于低发生率验证的实用解决方案包括使用实验室信息系统开发内部资源，对档案材料进行回顾性和前瞻性搜索，以及从外部资源购买组织微阵列块、载玻片或细胞系。事实证明，自制多组织块的使用在生物标志物研究中极其有价值，并且在临床免疫组织化学实验室中表现出巨大的实用性。参与外部质量评估计划可能无法提供足够的数量或计算一致性率的能力。然而，补充内部组织可以使实验室达到验证和/或验证方案所需的最佳病例数。另一种方法是进行彻底的文献检索，并将新测试的染色模式与预期结果相关联。这些解决方案可以单独使用或一起使用，以确保一致的标准化测试。