Evaluation of the diagnostic sensitivity (DSe) and specificity (DSp) of tests for infectious diseases in wild animals is challenging, and some of the limitations may affect compliance with the OIE-recommended test validation pathway. We conducted a methodologic review of test validation studies for OIE-listed diseases in wild mammals published between 2008 and 2017 and focused on study design, statistical analysis, and reporting of results. Most published papers addressed Mycobacterium bovis infection in one or more wildlife species. Our review revealed limitations or missing information about sampled animals, identification criteria for positive and negative samples (case definition), representativeness of source and target populations, and species in the study, as well as information identifying animals sampled for calculations of DSe and DSp as naturally infected captive, free-ranging, or experimentally challenged animals. The deficiencies may have reflected omissions in reporting rather than design flaws, although lack of random sampling might have induced bias in estimates of DSe and DSp. We used case studies of validation of tests for hemorrhagic diseases in deer and white-nose syndrome in hibernating bats to demonstrate approaches for validation when new pathogen serotypes or genotypes are detected and diagnostic algorithms are changed, and how purposes of tests evolve together with the evolution of the pathogen after identification. We describe potential benefits of experimental challenge studies for obtaining DSe and DSp estimates, methods to maintain sample integrity, and Bayesian latent class models for statistical analysis. We make recommendations for improvements in future studies of detection test accuracy in wild mammals.

评估野生动物传染病检测的诊断敏感性 (DSe) 和特异性 (DSp) 具有挑战性，一些限制可能会影响对 OIE 推荐的测试验证途径的遵守情况。我们对 2008 年至 2017 年间发表的 OIE 列出的野生哺乳动物疾病的测试验证研究进行了方法学审查，重点是研究设计、统计分析和结果报告。大多数发表的论文涉及牛分枝杆菌感染一种或多种野生动物。我们的审查揭示了样本动物、阳性和阴性样本的识别标准（病例定义）、源和目标种群的代表性以及研究中的物种的局限性或缺失信息，以及识别用于计算 DSe 和 DSp 的抽样动物的信息自然感染的圈养、自由放养或经过实验挑战的动物。这些缺陷可能反映了报告中的遗漏而不是设计缺陷，尽管缺乏随机抽样可能会导致对 DSe 和 DSp 的估计产生偏差。我们使用鹿出血性疾病和冬眠蝙蝠白鼻综合征测试验证的案例研究来展示当检测到新的病原体血清型或基因型并改变诊断算法时的验证方法，以及测试目的如何随着进化而演变病原体鉴定后。我们描述了获得 DSe 和 DSp 估计的实验性挑战研究的潜在好处、保持样本完整性的方法以及用于统计分析的贝叶斯潜在类模型。我们为改进野生哺乳动物检测测试准确性的未来研究提出了建议。我们描述了获得 DSe 和 DSp 估计的实验性挑战研究的潜在好处、保持样本完整性的方法以及用于统计分析的贝叶斯潜在类模型。我们为改进野生哺乳动物检测测试准确性的未来研究提出了建议。我们描述了获得 DSe 和 DSp 估计的实验性挑战研究的潜在好处、保持样本完整性的方法以及用于统计分析的贝叶斯潜在类模型。我们为改进野生哺乳动物检测测试准确性的未来研究提出了建议。