Research & Development
LumiraDx SARS-CoV-2 antigen test in symptomatic and asymptomatic patients shows encouraging results based on SKUP
13 January 2021 -

Diagnostic company LumiraDx announced on Tuesday that it has received a positive evaluation of the LumiraDx SARS-CoV-2 Antigen Test in point of care settings in a mixed population of symptomatic and asymptomatic subjects based on the Scandinavian evaluation of laboratory equipment for point of care testing (SKUP).

The LumiraDx SARS-CoV-2 Antigen Test reportedly uses Fast Microfluidic Immunofluorescence (FMI) technology to detect antigen nucleocapsid protein from nasal or nasopharyngeal swabs with high sensitivity results in 12 minutes. The test achieved 87-90% agreement with RT-PCR which increased to 92-95% in patients with viral load corresponding to Ct below 33. Test specificity was 99.5% in nasal swabs.

This SKUP evaluation was conducted in 448 subjects, including 197 who were asymptomatic and examined both nasal and nasopharyngeal samples, reported the company.

According to the company, the LumiraDx SARS-CoV-2 Antigen Test is currently commercially available in the US, Europe, Middle East, Africa and Asia Pacific under the US FDA's Emergency Use Authorization (EUA) for the detection of SARS-CoV-2 nucleocapsid protein.