This study evaluates the LumiraDx SARS-CoV-2 Antigen Test, a microfluidic immunofluorescence assay used to detect the nucleocapsid protein of SARS-CoV-2 in point of care testing, for the diagnosis of acute COVID-19 in children and adults.
When compared to point of care testing, lab diagnostic testing for COVID-19 poses a number of challenges. It is a costly and time-consuming method for diagnostic testing which vulnerable populations may struggle to gain access to. Low and middle-income countries may also lack the supply of reagents required to adequately test their communities. Another issue presented by lab testing is the slow turnaround time for receiving a test result, which may cause a delay in timely self-isolation, therefore allowing further transmission of the infection.
There is a growing and urgent demand for rapid high sensitivity point of care testing for COVID-19 due to these challenges presented by laboratory diagnostic testing.
In this study, the LumiraDx SARS-CoV-2 Antigen Test demonstrated a sensitivity of 97.6% and specificity of 96.6% up to 12 days post symptom onset for nasal swab samples, and a sensitivity of 97.5% and specificity of 97.7% for nasopharyngeal swab specimens. Diagnostic sensitivity was found to be 98.7% for nasal swabs from participants who tested within 10 days of symptom onset.
These results show that the LumiraDx SARS-CoV-2 Antigen Test offers the benefits of verifying infection quickly through point of care testing, enabling better management of COVID-19 infection in community-based settings and clinics.