Product Description
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 Wi-Fi connections.
Using Bulk Acoustic Wave (BAW) technology, the Qorvo Omnia platform is designed to deliver rapid test results for SARS-CoV-2 infections. BAW enables surface-based mass measurement using high frequency and surface binding. BAW allows for multi-plexing (multiple analytes from a single sample) and the test cartridge is designed to measure across multiple sample matrices such as whole blood, serum, plasma, saliva and more.
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.
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
Collecting and Processing Specimens
STEP 1: Add Sample
STEP 2: Insert Cartridge
STEP 3: Read Results
The system’s ease of use and rapid turnaround time of results enables a clinician’s access to test data in minutes.
THE TECHNOLOGY
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
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.
FEATURES & BENEFITS
- Fast: Results in approximately 20 minutes
- Versatile: Antibody and Antigen cartridges tested on the same instrument
- Easy to use: 3 simple steps
- Low limit of SARS-CoV-2 detection
- 100% Specificity; 89.5% Sensitivity
- Qualified using nasal swabs
PRODUCT DETAILS
You may place order by giving us a call
| Catalog Number | Description | Unit of Measurement |
| QBPR9002 | Qorvo Omnia Instrument | 1 Instrument |
| QBPR8302 | Qorvo Omnia SARS-CoV-2 Antigen Test | 20 tests/kit (MOQ: 2 kits) |
| QBPR8302QC | Qorvo Omnia SARS-CoV-2 Antigen Positive Control | 60 tests |
DOCUMENTATION AND VIDEOS
Brochure, package inserts and additional literature provided below:
The Qorvo Omnia™ Platform
The Qorvo Omnia™ Platform: How To Install
The Qorvo Omnia™ Platform Instructions
The Qorvo Omnia™ Platform: How To Use The Antigen Test
*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.
