Recently, the World Health Organization established the Diagnostic Technical Advisory Group to identify and prioritize diagnostic needs for neglected tropical diseases, and to ultimately describe the minimal and ideal characteristics for new diagnostic tests (the so-called target product profiles (TPPs)). We developed two generic frameworks: one to explore and determine the required sensitivity (probability to correctly detect diseased persons) and specificity (probability to correctly detect persons free of disease), and another one to determine the corresponding samples sizes and the decision rules based on a multi-category lot quality assurance sampling (MC-LQAS) approach that accounts for imperfect tests. We applied both frameworks for monitoring and evaluation of soil-transmitted helminthiasis control programs. Our study indicates that specificity rather than sensitivity will become more important when the program approaches the endgame of elimination and that the requirements for both parameters are inversely correlated, resulting in multiple combinations of sensitivity and specificity that allow for reliable decision making. The MC-LQAS framework highlighted that improving diagnostic performance results in a smaller sample size for the same level of program decision making. In other words, the additional costs per diagnostic tests with improved diagnostic performance may be compensated by lower operational costs in the field. Based on our results we proposed the required minimal and ideal diagnostic sensitivity and specificity for diagnostic tests applied in monitoring and evaluating of soil-transmitted helminthiasis control programs.

中文翻译：

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被忽视的热带病诊断测试所需性能的评估和相应程序决策规则的开发：作为案例研究的土壤传播的蠕虫病控制程序的监测和评估。

最近，世界卫生组织成立了诊断技术咨询小组，以确定被忽视的热带病的诊断需求并确定其优先级，并最终描述新诊断测试的最低限度和理想特征（所谓的目标产品概况（TPP））。我们开发了两个通用框架：一个用于探索和确定所需的灵敏度（正确检测出患病者的概率）和特异性（正确检测出无病者的概率），另一个用于确定相应的样本量和基于一种多类别批次质量保证抽样 (MC-LQAS) 方法，用于解决不完美的测试。我们应用这两个框架来监测和评估土壤传播的蠕虫病控制计划。我们的研究表明，当程序接近淘汰赛的最后阶段时，特异性而不是敏感性将变得更加重要，并且两个参数的要求呈负相关，从而导致敏感性和特异性的多种组合，从而做出可靠的决策。MC-LQAS 框架强调，提高诊断性能会导致相同级别的程序决策的样本量更小。换句话说，具有改进的诊断性能的每次诊断测试的额外成本可以通过较低的现场操作成本来补偿。根据我们的结果，我们提出了用于监测和评估土壤传播的蠕虫病控制程序的诊断测试所需的最低和理想的诊断灵敏度和特异性。