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

Clin Chem Lab Med. 2021 Apr 28;59(9):1507-1515. doi: 10.1515/cclm-2021-0455. Print 2021 Aug 26.


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.

Keywords: SARS-CoV-2 antigen rapid detection tests; asymptomatic individuals; laboratory-based immunoassays for SARS-CoV-2 detection; point-of-care immunoassays for SARS-CoV-2 detection; severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2); symptomatic individuals.

MeSH terms

  • Antigens, Viral / immunology*
  • Asymptomatic Infections / classification
  • COVID-19 / diagnosis*
  • COVID-19 / immunology
  • COVID-19 / virology
  • Humans
  • Immunoassay / standards*
  • Point-of-Care Testing / standards*
  • Practice Guidelines as Topic / standards*
  • SARS-CoV-2 / immunology*
  • SARS-CoV-2 / isolation & purification*


  • Antigens, Viral