Ochwo Sylvester, Perez Andres M, Pérez Aguirreburualde María Sol
Center for Animal Health and Food Safety, College of Veterinary Medicine, University of Minnesota, Saint Paul, MN, United States.
Front Vet Sci. 2023 Aug 31;10:1239111. doi: 10.3389/fvets.2023.1239111. eCollection 2023.
The growing availability of point-of-care tests (POCTs) for food-animal diseases offers opportunities for timely diagnosis, facilitating the efficient implementation of control measures. However, field assessment of new POCTs are yet to be standardized. This paper discusses the opportunity of expanding the current approach for the evaluation and validation of POCTs in food animal disease diagnosis, highlighting the limitations of traditional practice that primarily relies on estimating diagnostic accuracy (sensitivity and specificity). Here, the use of a protocol referred to as FIT-REASSURED, a modified framework combining the ASSURED and REASSURED criteria, is proposed to comprehensively assess POCTs. FIT-REASSURED encompasses key criteria such as fitness for purpose, real-time connectivity, ease of specimen collection, affordability, sensitivity, specificity, user-friendliness, rapidity and robustness, equipment-free operation, and deliverability. By incorporating these attributes, FIT-REASSURED provides a customizable approach to assess the accuracy, affordability, and utility of POCTs. Through collaborative efforts among stakeholders, the implementation of a standardized scorecard based on these FIT-REASSURED criteria can improve the reliability and practicality of POCTs in food-animal health.
用于食用动物疾病的即时检验（POCT）日益普及，为及时诊断提供了机会，有助于有效实施控制措施。然而，对新型POCT的现场评估尚未标准化。本文讨论了扩大当前食用动物疾病诊断中POCT评估和验证方法的机会，强调了主要依赖估计诊断准确性（敏感性和特异性）的传统做法的局限性。在此，提出使用一种称为FIT-REASSURED的方案，这是一种结合了ASSURED和REASSURED标准的改进框架，以全面评估POCT。FIT-REASSURED包含关键标准，如适用性、实时连接性、样本采集简便性、可承受性、敏感性、特异性、用户友好性、快速性和稳健性、无需设备操作以及可交付性。通过纳入这些属性，FIT-REASSURED提供了一种可定制的方法来评估POCT的准确性、可承受性和实用性。通过利益相关者之间的合作努力，基于这些FIT-REASSURED标准实施标准化记分卡可以提高POCT在食用动物健康方面的可靠性和实用性。
