Why carry out this study?

There is an urgent need to improve access to point-of-care testing for SARS-CoV-2 during the COVID-19 pandemic.

The LumiraDx SARS-CoV-2 antigen test, which uses a high-sensitivity, microfluidic immunoassay to detect the nucleocapsid protein of SARS-CoV-2, was evaluated for diagnosing acute COVID-19 in adults and children across point-of-care settings.

What was learned from the study?

A 12-min nasal swab test detects 97.6% of COVID-19 infections, compared to gold standard real-time PCR testing, up to 12 days following symptom onset using a microfluidic immunoassay for SARS-CoV-2 nucleocapsid protein.

This rapid assay with high sensitivity and anterior nasal sampling offers significant advantages for identification and management of SARS-CoV-2 infection, particularly in clinic- and community-based settings.