Antigen-detection in the diagnosis of SARS-CoV-2 infection: interim guidance, 6 October 2021

ABSTRACT

Diagnostic testing for SARS-CoV-2 is a critical component to the overall prevention and control strategy for COVID-19. Countries should have a national testing strategy in place with clear objectives that can be adapted according to changes in the epidemiological situation, available resources and tools, and country-specific context. It is critical that all SARSCoV-2 testing is linked to public health actions to ensure appropriate clinical care and support and to carry out contact tracing to break chains of transmission. Since the early days of the SARS-CoV-2 pandemic, laboratories have been using nucleic acid amplification tests (NAATs), such as real time reverse transcription polymerase chain reaction (rRT-PCR) assays, to detect SARS-CoV-2, the virus that causes COVID-19. Since mid-2020, less expensive and faster diagnostic tests that detect antigens specific for SARS-CoV-2 infection have become commercially available, and several have achieved WHO Emergency use listing. Antigen-detecting diagnostic tests are designed to directly identify SARS-CoV-2 proteins produced by replicating virus in respiratory secretions (or oral fluid/saliva) and have been developed as both laboratory-based tests and rapid diagnostic tests (RDTs) intended for near-patient use. The diagnostic development landscape is dynamic, with over two hundred tests for SARS-CoV-2 antigen detection on the market, of which 85% can be delivered at the point of care and the other 15% for use on high throughput machines in laboratory-based settings.