New Revised Clinical and Laboratory Standards Institute Guidelines for Immunohistochemistry and Immunocytochemistry

摘要

The Clinical and Laboratory Standards Institute (CLSI) (www.clsi.org) is, in its own words, "an international, interdisciplinary, nonprofit, standards developing, and educational organization that promotes the development and use of voluntary consensus standards and guidelines within the health care community."1 As such CLSI develops and releases "Standards," "Guidelines," and "Reports," pertaining to diverse areas of clinical and diagnostic laboratory practice. "Standards," identifying "specific essential requirements for materials, methods, or practices;" and "Guidelines," describing "criteria for general operating practice, procedure or material," are developed by an extensive consensus process. In this context, the long awaited, extensively revised guidelines for immunohistochemistry (IHC) and immunocytochemistry (ICC) have recently been published, under the title, "Quality Assurance for Design Control and Implementation of Immunohistochemistry Assays; Approved Guideline-Second Edition (I/LA28-A2).