Boone D J
Division of Assessment and Management Consultation, Centers for Disease Control, Atlanta, GA 30333.
Arch Pathol Lab Med. 1988 Apr;112(4):354-6.
Historically, the quality of laboratory performance that must be provided to adequately support medical decision-making has been defined in three major ways: by the analytical variance of the state of the practice; by the total variance, including the expected analytical and biological variability; and by medical-usefulness criteria. Quality goals defined by these approaches have influenced instrument manufacturers, professional societies, governmental agencies, and even the precision and accuracy of medical practice. Despite past efforts, a consensus has not emerged on a scientifically and medically supportable set of laboratory performance requirements. Medically relevant goals for analytic performance would help avoid costly and unnecessary regulatory requirements and permit steady improvement in instrumentation and methods.
从历史上看，为充分支持医疗决策而必须提供的实验室检测性能质量主要通过三种方式来定义：根据实际操作状态的分析方差；根据总方差，包括预期的分析和生物变异性；以及根据医学实用性标准。这些方法所定义的质量目标已经影响了仪器制造商、专业协会、政府机构，甚至医疗实践的精度和准确性。尽管过去做出了努力，但尚未就一套科学和医学上可支持的实验室检测性能要求达成共识。分析性能的医学相关目标将有助于避免代价高昂且不必要的监管要求，并使仪器和方法得以稳步改进。
