Nichols James H
Tufts University School of Medicine and Baystate Health, Springfield, Massachusetts 01199, USA.
Adv Clin Chem. 2009;47:121-37. doi: 10.1016/s0065-2423(09)47005-7.
Method verification, a one-time process to determine performance characteristics before a test system is utilized for patient testing, is often confused with method validation, establishing the performance of a new diagnostic tool such as an internally developed or modified method. A number of international quality standards (International Organization for Standardization (ISO) and Clinical Laboratory Standards Institute (CLSI)), accreditation agency guidelines (College of American Pathologists (CAP), Joint Commission, U.K. Clinical Pathology Accreditation (CPA)), and regional laws (Clinical Laboratory Improvement Amendments of 1988 (CLIA'88)) exist describing the requirements for method verification and validation. Consumers of marketed test kits should verify method accuracy, precision, analytic measurement range, and the appropriateness of reference intervals to the institution's patient population. More extensive validation may be required for new methods and those manufacturer methods that have been modified by the laboratory, including analytic sensitivity and specificity. This manuscript compares the various recommendations for method verification and discusses the CLSI evaluation protocols (EP) that are available to guide laboratories in performing method verification experiments.
方法验证是在测试系统用于患者检测之前确定性能特征的一次性过程，它常与方法确认相混淆，方法确认是确定新诊断工具（如内部开发或修改的方法）的性能。一些国际质量标准（国际标准化组织（ISO）和临床实验室标准协会（CLSI））、认可机构指南（美国病理学家学会（CAP）、联合委员会、英国临床病理认证（CPA））以及地区法律（1988年临床实验室改进修正案（CLIA'88））都对方法验证和确认的要求进行了描述。市售检测试剂盒的使用者应验证方法的准确性、精密度、分析测量范围以及参考区间对机构患者群体的适用性。对于新方法以及实验室对制造商方法进行修改后的方法，可能需要进行更广泛的确认，包括分析灵敏度和特异性。本文比较了方法验证的各种建议，并讨论了可用于指导实验室进行方法验证实验的CLSI评估方案（EP）。
