本指南概述了样本要求；绩效标准；可能使用顺序或重复测试的算法；用于检测传染病的免疫检测试剂盒的方法间比较建议；以及标准物质开发规范。本文件不再作为CLSI共识过程的一部分进行审查。然而，由于它对医疗保健界的有限部分有用，CLSI正在继续提供该文档的信息内容。本文件仅提供电子版。

This guideline outlines specimen requirements; performance criteria; algorithms for the potential use of sequential or duplicate testing; recommendations for intermethod comparisons of immunological test kits for detecting infectious diseases; and specifications for development of reference materials.This document is no longer being reviewed as part of the CLSI consensus process. However, because of its usefulness to a limited segment of the healthcare community, CLSI is continuing to make the document available for its informational content.This document is available in electronic format only.