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.
Supporting healthier lives, for individuals, communities and wider society.
Enabling responsive, personal relationships between patients and care teams.
Controlling and reducing costs to help ease pressure on healthcare budgets.