Qorvo Biotechnologies OmniaTM Platform- BAW-Based Biosensors For COVID-19 And Beyond

ABSTRACT

This paper describes the Qorvo Biotechnologies Omnia testing system using bulk acoustic wave (BAW) sensor technology and performance data generated in a study conducted by the National Institutes of Health (NIH) as part of the RADx initiative for SARS-CoV-2 antigen testing. The Qorvo Omnia SARS-CoV-2 Antigen test was granted Emergency Use Authorization (EUA) for the qualitative detection of SARS-CoV-2 nucleocapsid viral antigens from direct anterior nasal swab specimens without transport media from symptomatic individuals who are suspected of COVID-19 by their healthcare provider within the first six days of symptom onset. The study illustrates the ease-of-use of the system and provides specific performance data Limit of Detection (LoD) determination and a prospective study in two patient cohorts versus two high sensitivity real time polymerase chain reaction (RT-PCR) comparative methods, the Roche cobas® 6800 RT-PCR system (1800 NDU/mL) and the Hologic Panther® RT-PCR system (600 NDU/mL). © 2022 MANTECH 2022. All rights reserved.