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Abstract：
With an almost unremittent progression of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections all around the world, there is a compelling need to introduce rapid, reliable, and high-throughput testing to allow appropriate clinical management and/or timely isolation of infected individuals. Although nucleic acid amplification testing (NAAT) remains the gold standard for detecting and theoretically quantifying SARS-CoV-2 mRNA in various specimen types, antigen assays may be considered a suitable alternative, under specific circumstances. Rapid antigen tests are meant to detect viral antigen proteins in biological specimens (e.g. nasal, nasopharyngeal, saliva), to indicate current SARS-CoV-2 infection. The available assay methodology includes rapid chromatographic immunoassays, used at the point-of-care, which carries some advantages and drawbacks compared to more conventional, instrumentation-based, laboratory immunoassays. Therefore, this document by the International Federation for Clinical Chemistry and Laboratory Medicine (IFCC) Taskforce on COVID-19 aims to summarize available data on the performance of currently available SARS-CoV-2 antigen rapid detection tests (Ag-RDTs), providing interim guidance on clinical indications and target populations, assay selection, and evaluation, test interpretation and limitations, as well as on pre-analytical considerations. This document is hence mainly aimed to assist laboratory and regulated health professionals in selecting, validating, and implementing regulatory approved Ag-RDTs.
摘要：
随着严重急性呼吸道综合症冠状病毒2（SARS-CoV-2）感染在世界各地几乎没有进展，迫切需要引入快速，可靠,和高通量测试，以允许适当的临床管理和/或及时隔离受感染的个体。尽管核酸扩增检测（NAAT）仍然是检测和理论上定量各种标本类型中SARS-CoV-2mRNA的金标准，抗原测定可以被认为是一个合适的替代方案，在特定情况下。快速抗原测试旨在检测生物标本中的病毒抗原蛋白（例如鼻，鼻咽,唾液)，表明当前SARS-CoV-2感染。可用的测定方法包括快速色谱免疫测定，用于护理点，与更传统的相比，它具有一些优点和缺点，基于仪器的，实验室免疫测定。因此,国际临床化学和实验室医学联合会(IFCC)COVID-19工作组的这份文件旨在总结目前可用的SARS-CoV-2抗原快速检测试验(Ag-RDT)性能的现有数据，为临床适应症和目标人群提供临时指导，测定选择，和评估，测试解释和限制，以及分析前的考虑。因此，该文件主要旨在协助实验室和受监管的卫生专业人员选择，正在验证,并实施监管批准的Ag-RDT。
