IFCC interim guidelines on rapid point-of-care antigen testing for SARS-CoV-2 detection in asymptomatic and symptomatic individuals

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 allow appropriate clinical management and/or timely isolation infected individuals. Although nucleic acid amplification (NAAT) remains gold standard for detecting theoretically quantifying SARS-CoV-2 mRNA in various specimen types, antigen assays may be considered suitable alternative, under specific circumstances. Rapid tests are meant detect viral proteins biological specimens (e.g. nasal, nasopharyngeal, saliva), indicate current infection. The available assay methodology includes rapid chromatographic immunoassays, used at point-of-care, which carries some advantages drawbacks compared more conventional, instrumentation-based, laboratory immunoassays. Therefore, this document by International Federation Clinical Chemistry Laboratory Medicine (IFCC) Taskforce on COVID-19 aims summarize data performance currently detection (Ag-RDTs), providing interim guidance indications target populations, selection, evaluation, test interpretation limitations, as well pre-analytical considerations. This hence mainly aimed assist regulated health professionals selecting, validating, implementing regulatory approved Ag-RDTs.