Kinas Carrie G, Carroll Bryan T
*Department of Dermatology, Eastern Virginia Medical School, Norfolk, Virginia;†Department of Dermatology, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.
Dermatol Surg. 2017 Apr;43(4):507-511. doi: 10.1097/DSS.0000000000001033.
The adoption of recently created protocols introduces Mohs laboratories to the principles of immunohistochemistry (IHC) performance validation and clinical laboratory regulations that are unique to these evolving technologies.
To review Food and Drug Administration (FDA) IHC reagent classifications, IHC validation protocols, and quality assurance (QA) procedures and documentation needed in conjunction with IHC test guidelines.
A focused review of IHC reagent classifications and guidelines in clinical testing laboratories was conducted using PubMed and FDA source documents.
The IHC regulation requirements are determined by the 3 FDA classifications of reagents: in vitro diagnostic reagents, analyte-specific reagents, and research use only reagents. To account for performance variability, IHC reagents benefit from routine validation and QA programs. We present our IHC adoption procedures for QA and documentation of IHC tests in a Mohs laboratory.
Incorporating a well-organized IHC validation and QA program into Mohs laboratories can increase regulatory compliance and reagent performance.
采用最近制定的方案使莫氏实验室了解免疫组织化学（IHC）性能验证原则以及这些不断发展的技术所特有的临床实验室法规。
回顾美国食品药品监督管理局（FDA）的免疫组化试剂分类、免疫组化验证方案以及结合免疫组化检测指南所需的质量保证（QA）程序和文件。
使用PubMed和FDA源文件对临床检测实验室中的免疫组化试剂分类和指南进行重点回顾。
免疫组化法规要求由FDA的3种试剂分类决定：体外诊断试剂、分析物特异性试剂和仅用于研究的试剂。为了应对性能变异性，免疫组化试剂受益于常规验证和质量保证计划。我们展示了我们在莫氏实验室中进行免疫组化检测的质量保证和文件记录的采用程序。
将组织良好的免疫组化验证和质量保证计划纳入莫氏实验室可提高法规合规性和试剂性能。
