For reliable clinical decisions in transfusion medicine, assessing the performance of qualitative tests performed in medical laboratories is critical. When false results are reported, these can lead to an adverse reaction to blood components. Good performance assessment practices are essential for this kind of scenario, and they still remain as one of the many unmet high-priority challenges in this area. This paper aims to provide an overview of the current trends in this field. A review of the IFCC-IUPC. qualitative vocabulary was carried out, and a particular focus was given to the evaluation protocols CLSI EP12-A3 and Eurachem AQA, such as the European Union Regulation for class D diagnostic medical devices. There is a consistency between the current protocols and recognized performance assessment principles, which are mandatory in transfusion service labs. We believe that a revised imprecision interval approach and models based on emerging qualitative test types may prove beneficial in the long run. It is also important to emphasize the uncertainty of proportions to mitigate the risk of misclassification.

中文翻译：

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聚焦输血医学中定性体外诊断医疗器械性能评估的趋势

为了在输血医学方面做出可靠的临床决策，评估医学实验室进行的定性测试的性能至关重要。当报告错误结果时，可能会导致对血液成分的不良反应。良好的绩效评估实践对于这种情况至关重要，并且仍然是该领域许多未解决的高度优先挑战之一。本文旨在概述该领域的当前趋势。对 IFCC-IUPC 的审查。进行了定性词汇，特别关注评估协议 CLSI EP12-A3 和 Eurachem AQA，例如欧盟 D 类诊断医疗器械法规。当前协议与公认的绩效评估原则之间存在一致性，这些原则在输血服务实验室中是强制性的。我们相信，从长远来看，基于新兴定性测试类型的修订后的不精确区间方法和模型可能是有益的。强调比例的不确定性以减轻错误分类的风险也很重要。