The test is authorised only for the identification of proteins from SARS-CoV-2 and not for any other viruses or pathogens
Qorvo Biotechnologies, a wholly-owned subsidiary of Qorvo, has secured an emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its Qorvo Omnia SARS-CoV-2 antigen test.
The EUA enables to use the test for the qualitative detection of nucleocapsid viral antigens from SARS-CoV-2 in nasal swab specimens from individuals who are suspected of Covid-19.
The Qorvo Omnia platform is said to use high frequency Bulk Acoustic Wave (BAW) sensors to complete SARS-CoV-2 antigen testing in around 20 minutes.
According to the company, BAW sensor technology permits low Limit of Detection (LOD) levels, which are similar to molecular testing capability.
The Qorvo Omnia platform consists of a portable test instrument, microfluidic cartridge and secure connectivity.
Qorvo said that the microfluidic cartridge design facilitates specific binding with additional wash steps similar to central lab instrument operation and have shown results including 100% specificity during clinical trials,
According to the company, the test is authorised only for the identification of proteins from SARS-CoV-2 and not for any other viruses or pathogens.
Qorvo Biotechnologies president James Klein said: “The FDA’s EUA is recognition that the Qorvo Omnia platform can help address the ongoing need for rapid, accurate and clinically-reliable diagnostic testing.
“We are honoured to leverage Qorvo’s technology portfolio to help public health officials respond to this global pandemic.”
Qorvo Biotechnologies is engaged in the development of point-of-care (POC) diagnostics solutions using BAW sensor technology.
Recently, Becton, Dickinson and Company (BD) secured FDA EUA status for its rapid antigen test to screen SARS-CoV-2 via serial testing of asymptomatic individuals.
The BD Veritor Plus System for Rapid Detection of SARS-CoV-2 is designed to facilitate the qualitative detection of SARS-CoV-2 nucleocapsid antigens in direct anterior nasal swabs from individuals who are either suspected of Covid-19 by their health care provider within the first five days of the onset of symptoms.