COVID-19 test kit

infectionfor antigensSARS-COV-2

The LumiraDx SARS-CoV-2 Ag Test is a microfluidic immunofluorescence assay for the direct and qualitative detection of nucleocapsid protein antigen in nasal and nasopharyngeal swab specimens from individuals suspected of COVID-19 or asymptomatic individuals. Used with the LumiraDx Platform the test delivers rapid results at the point of care. Test benefits The use of a LumiraDx SARS-CoV-2 Ag Test on the LumiraDx Instruments will enable the physician to verify infection quickly, begin proper treatment and to initiate isolation precautions helping prevent further spread of infection. Easy to implement in point of care settings Clinical performance 97.6% positive percent agreement 96.6% negative percent agreement Analytical performance with a limit of detection of 32 TCID50/mL RT-PCR comparable results within 12 days of onset of symptoms Test workflow The Instrument and Test Strips are integrated with several quality control checks to ensure the Instrument and Test are functioning correctly for every test run. The workflow process is comprised of a simple sample prep along with step-by-step guidance of the Instrument to report a patient result in under 12 minutes from sample application. Test performance In clinical studies, the LumiraDx SARS-CoV-2 antigen test demonstrated 97.6% positive agreement versus RT-PCR in patients tested within 12 days of the onset of symptoms, to enable the physician to verify infection quickly, begin proper treatment and to initiate isolation precautions helping prevent further spread of infection. 100% positive agreement was achieved with samples with cycle threshold values (ct) < 33 (Roche Cobas 6800 SARS-CoV-2 reference method)