Flatland Bente, Friedrichs Kristen R, Klenner Stefanie
Department of Biomedical and Diagnostic Sciences, College of Veterinary Medicine, University of Tennessee, Knoxville, TN, USA.
Vet Clin Pathol. 2014 Dec;43(4):475-86. doi: 10.1111/vcp.12199. Epub 2014 Sep 24.
Prior to introduction of a new method to the diagnostic laboratory, analytical performance must be validated to ensure operation within the manufacturer's specifications and/or within predetermined quality requirements. In addition, the new method may require diagnostic performance assessment to ensure it differentiates between diseased and nondiseased individuals as intended. These 2 phases of assessment, while complementary, are not equivalent and require a different set of experiments, statistical analyses, and interpretation. Studies of analytical performance typically include a method comparison experiment, the purpose of which is to identify bias (inaccuracy) of the "test" (or "index") method (new method) relative to a "comparative method" (established method). Analysis of method comparison data is facilitated by commercial software programs that present the statistical significance of identified bias; however, the clinical relevance of any bias also should be considered. Studies of diagnostic performance should not be pursued until analytical performance is fully characterized and may not be required for well-established tests or for those for which results are nonspecific (ie, not referable to a specific disease or condition). Diagnostic performance assessment may include assessment of sensitivity, specificity, predictive values, odds ratios, and/or likelihood ratios. The purpose of this review is to clarify differences between the assessment of analytical and diagnostic performance, and to explore the method comparison study and bias assessment from a perspective not addressed in prior veterinary articles.
在将一种新方法引入诊断实验室之前，必须对分析性能进行验证，以确保其在制造商规定的规格范围内和/或在预定的质量要求范围内运行。此外，新方法可能需要进行诊断性能评估，以确保它能按预期区分患病个体和未患病个体。这两个评估阶段虽然相辅相成，但并不等同，需要不同的实验、统计分析和解释。分析性能研究通常包括方法比较实验，其目的是确定“测试”（或“指标”）方法（新方法）相对于“比较方法”（既定方法）的偏差（不准确）。商业软件程序有助于分析方法比较数据，这些程序会显示已识别偏差的统计学显著性；然而，还应考虑任何偏差的临床相关性。在分析性能得到充分表征之前，不应进行诊断性能研究，对于成熟的测试或结果不具特异性的测试（即，不能归因于特定疾病或病症的测试），可能也不需要进行诊断性能研究。诊断性能评估可能包括对敏感性、特异性、预测值、比值比和/或似然比的评估。本综述的目的是阐明分析性能评估和诊断性能评估之间的差异，并从先前兽医文章未涉及的角度探讨方法比较研究和偏差评估。
