Rev Sci Tech. 2021 Jun;40(1):19-28. doi: 10.20506/rst.40.1.3207.
The World Organisation for Animal Health (OIE) has made leading contributions to the discipline of test validation science by providing standards and guidelines that inform the test validation process in terrestrial and aquatic animals. The OIE Manual of Diagnostic Tests and Vaccines for Terrestrial Animals, and the Manual of Diagnostic Tests for Aquatic Animals describe the test validation pathway in the context of fitness for purpose, elaborate on the importance of diagnostic sensitivity (DSe) and specificity (DSp) as measures of test accuracy, and designate additional factors (e.g. test cost, laboratory throughput capacity and rapidity of test results) that influence choices of a single test over others or the inclusion of a new test in a diagnostic process that includes multiple tests. This paper provides examples of each of the six main testing purposes listed in the Terrestrial Manual and describes additional metrics such as ruggedness and robustness that should be included in the validation of point-of-care tests. Challenges associated with new diagnostic technologies and platforms are described. Validated tests with estimates of DSe and DSp are needed to measure confidence in test results for OIE-listed diseases, to facilitate risk assessments related to animal movement, to estimate true prevalence, and for certification of disease freedom and use in epidemiological (risk factor) studies.
世界动物卫生组织（OIE）通过提供陆地和水生动物检验验证过程的标准和准则，为检验验证科学做出了主要贡献。《陆生动物诊断试验和疫苗手册》和《水生动物诊断试验手册》在适合目的的背景下描述了检验验证途径，详细说明了诊断灵敏度（DSe）和特异性（DSp）作为检验准确性衡量标准的重要性，并指定了其他影响选择单个检验而不是其他检验的因素（例如检验成本、实验室吞吐量和检验结果的快速性）或包含多个检验的诊断过程中的新检验。本文提供了《陆生手册》中列出的六个主要检验目的中的每一个的示例，并描述了其他指标，如坚固性和稳健性，这些指标应包含在即时检验的验证中。还描述了与新诊断技术和平台相关的挑战。需要具有 DSe 和 DSp 估计值的经过验证的检验来衡量对 OIE 列出疾病的检验结果的信心，以促进与动物运动相关的风险评估、估计真实流行率，以及用于疾病自由认证和流行病学（风险因素）研究。
