Obtain SARS-CoV-2 Test Results within minutes
The Qorvo Omnia System is a small instrument measuring 10” x 9” x
5”. It features a menu-driven touchscreen that provides instructions
for every step of the test procedure, with on-screen test results
that can be printed or uploaded by Ethernet, Cellular or
The Qorvo Omnia System is a mini lab bench:
- The test cartridge is a self-contained, wet-chemistry testing device
The instrument processes the reaction steps
in the cartridge
- The instrument generates rapid results in approximately 20 minutes
Video of the Qorvo Omnia SARS-CoV-2 Antigen Test:
Designed to Achieve Rapid Test Results.
The U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for the Qorvo Omnia SARS-CoV-2 Antigen Test. The SARS-CoV-2 Antigen test uses immunoassay principles for the qualitative detection of nucleocapsid viral antigens from individuals within the first six days of symptom onset.
- Low limit of SARS-CoV-2 detection
- 100% Specificity; 89.5% Sensitivity
- Qualified using nasal swabs
IgG Antibody Test**
- Detects both S1 and nucleocapsid
Quantifiable results with antibody level compared
to cut-off value
- Qualified using serum, plasma and whole blood samples
*This product has not been FDA cleared or approved, but has been
authorized by FDA under an EUA for use by authorized laboratories.
This product has been authorized only for the detection of proteins
from SARS-CoV-2, not for any other viruses or pathogens; and the
emergency use of this product is only authorized for the duration of
the declaration that circumstances exist justifying the
authorization of emergency use of in vitro diagnostics for detection
and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal
Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the
declaration is terminated or authorization is revoked sooner.
**These statements reflect the data submitted to the FDA under the EUA process. The Qorvo Biotechnologies IgG Antibody Test has not been reviewed by the FDA and is not available for sale. An application for Emergency Use Authorization (EUA) of this test has been submitted to the FDA and is pending. The application is for use of the test in CLIA laboratories certified to perform moderate- and high-complexity testing.
Innovative Radio Frequency Technology Aims to Achieve High
Sensitivity and Specificity
Qorvo Biotechnologies brings a unique approach to the health diagnostics testing landscape by leveraging the power of BAW radio frequency (RF) technology—a proven technology currently used in applications you are already familiar with, such as Wi-Fi routers, 5G cellular towers and mobile phones.
It Starts with the Sensor
Probe Signal In The RF signal is delivered to the BAW sensor as the fluid moves over the surface.
Piezo Device Vibrates The sensor resonance frequency is modulated as mass is added to the surface.
Modified Signal Out The RF signal is output to the instrument.
- With BAW RF technology, sensitivity (Limit of Detection) increases with frequency
- Qorvo’s BAW resonates at 3GHz frequency — 3 billion cycles per second
- Sensitivity scales with the square of the frequency, making certain assays capable of 1 pg/mL LOD with BAW
- Changes in mass from surface binding are easily measured through RF detection
- Fundamental technology enables millions of mobile phones worldwide — repurposed as a high sensitivity sensor for use in biotechnology applications
Initial frequency reading under fluidic conditions
Mass is added to the surface causing a frequency reduction
The final output signal can be used to calculate a total frequency shift proportional to the mass binding
Test Cartridge and Reagent Carousel
- Low-cost injection molded cartridge body contains the BAW sensor and a pipette tip
- The foil-sealed reagent carousel contains reagents and wash buffers to reduce non-specific binding—the cartridge acts as a portable laboratory chemistry bench
- The Qorvo Omnia instrument actuates the carousel motion during the test process
Download necessary documents such as test cartridge Instructions for Use, the Qorvo Omnia Instrument Operating Manual, Quick Start Guides and Safety Datasheets (SDS).
News and Events
Here you'll find the latest news and information from Qorvo Biotechnologies. Browse through our press releases, latest videos, upcoming events and related content.