Information is power. As the COVID-19 pandemic has illustrated, timely and accurate information is essential to fighting infectious diseases. Vaccines and safety precautions can go a long way toward returning society to a sense of normalcy. But there is a reason that public health experts continue to promote rapid and reliable testing, particularly as new variants of interest or concern rear their heads.
Swift, accurate, and accessible testing gives community members vital information that impacts how they care for themselves and those around them to reduce the spread of disease. Pharmacies have become a hot-bed for COVID-19 testing options, but until recently, pharmacists and clinicians have often found themselves having to make trade-offs between sensitivity and specificity, speed, workflow fit, and error rates. Today, such sacrifices may no longer be necessary given the potential of the Qorvo Biotechnologies Omnia™ test platform and SARS-CoV-2 antigen test.
Seeking the Best of Both Worlds
Qorvo’s innovation seeks to straddle the gold standard for COVID-19 identification—polymerase chain reaction (PCR) molecular tests—and rapid antigen tests. PCR tests detect the virus’s genetic material, even at low levels, and are processed by a central laboratory in many instances, as well as with multiple product options in point-of-care (POC) settings. Turn-around time is lengthy for central laboratory testing, although even PCR POC is a time-consuming testing process.
Rapid lateral flow tests can provide results in just 15 to 20 minutes. Typically designed as antigen tests that spot viral proteins, these kits are relatively simple to use. However, these tests tend to perform best with more virus present given their reduced ability to detect low viral levels, so they can miss mild or asymptomatic cases, giving a false sense of security and increasing the risk of false negatives and associated risk of viral spread versus PCR testing. This is especially true for the most recent Omicron variant, whose viral load distribution has created challenges for rapid antigen lateral flow tests.
Beyond the performance issues mentioned above, workflow fit and error-rate issues remain for end users. In a pharmacy setting, the requirement of time-read windows combined with the manual data entry associated with lateral flows creates additional challenges. Even with POC molecular options, long time to result and high error rates associated with product designs not optimized for high-traffic testing environments have shown the problems that occur when products are not a good workflow fit. There remains a strong need for tools that can mimic the performance of PCR tests while providing the cost, accessibility, and convenience advantages of typical antigen tests. Qorvo’s Omnia system is poised to hit this sweet spot.
Unlike traditional diagnostic approaches that rely on optical or fluorescence detection, Qorvo uses high-frequency Bulk Acoustic Wave (BAW) sensors—tested technology already used in cellphones and Wi‑Fi routers—to detect the presence of COVID-19 antigens from an anterior nasal swab. A small cartridge the size of a credit card containing the BAW sensor is used to measure a reaction between the biochemical coating on the BAW sensor surface and the sample being tested. As mass is added to the surface, a change in frequency occurs that can be converted to a known concentration.
The BAW sensor’s extremely high frequency (it resonates at 3 GHz, or 3 billion cycles per second) enables a low limit of detection (LOD) and is 100% specific, which is critical in low-prevalence settings to minimize false positives. Like rapid tests, results can be available in as little as 20 minutes; but unlike current quick-turnaround tests familiar to most pharmacies, the level of accuracy in detecting even low viral loads approaches that of some PCR tests. Importantly, this performance benchmark has recently been confirmed in a clinical study of suspected Omicron samples. In this study, more than 100 samples were tested during the timeframe when Omicron was the dominant variant. A subset of these were sequenced, with 100% of sequenced samples showing to be the Omicron variant. Percent Positive Agreement was statistically matched to Qorvo’s existing EUA data collected prior to the Omicron variant. This is critical, because with the viral load distribution in Omicron samples, many lateral flow devices are unable to detect the virus at historically required levels. This data suggests that the Omnia platform is a great option for pharmacy environments where performance is important.
“This new approach to testing has the potential to transform disease detection,” said Fred S. Apple, PhD, a member of Qorvo Biotechnologies’ advisory board, co-medical director of the Toxicology Laboratory at Hennepin Healthcare and Hennepin County Medical Center, and professor of Laboratory Medicine & Pathology at the University of Minnesota. “The Qorvo Omnia system is focused on producing results comparable to PCR testing with the ability to be deployed for a wide range of rapid point-of-care diagnostic tests.”
Watch this video for a simple technical overview of Qorvo’s biotech platform.
NIH Study Validates Utility and Performance
In March 2021, the National Institutes of Health (NIH) conducted an internal investigation of Qorvo’s system, finding that LOD claims based on the company’s internal data, as well as the sensitivity of the detection core, were valid. The NIH’s study indicates that the Omnia platform can achieve results that are comparable to some high-sensitivity molecular (or PCR) testing systems, and the design of the system was noted as intuitive, simple, and easy to use.
In the following month, the Qorvo Biotechnologies Omnia™ test platform and SARS-CoV-2 antigen test gained Emergency Use Authorization from the FDA. Also in the spring, it was awarded a $24.4 million contract from the NIH to spur production and a market launch. The award, funded by the Biological Advanced Research and Development Authority through the Rapid Acceleration of Diagnostics initiative, underscores the capabilities of the new system to work rapidly while providing high assurance of the veracity of results.
Further, in May, the NIH-funded Atlanta Center for Microsystems Engineered Point-of-Care Technologies selected the Omnia platform for another internal study, this time to test for variants of interest and concern. The study indicated that Qorvo’s technology could detect variants circulating in the United States at that time with high sensitivity. Since then, epitope mapping has been completed by this group, confirming the high affinity of Qorvo antibodies and the lack of any mutations of concern of historical and current variants.
Easy Integration in Fast-paced Environments
Pharmacies and clinics conducting COVID-19 testing are doing so on top of their normal workloads, adding greater complexity and urgency to workflows. The Omnia apparatus was developed to fit seamlessly into the mix, with its testing platform designed with a small countertop footprint and compatible with compact testing cartridges. Electronic data management further streamlines the testing process, with a strong chain of custody built in.
Customers first scan a QR code to register their information, and their testing cartridge is then scanned and connected to their account. Once a nasal swab is received as a sample, it is encased in a lysis buffer in the cartridge to preserve its stability for 24 hours. Pharmacies have the flexibility to either process tests immediately in urgent situations or in batches as their workflow permits. Results, generated in 20 minutes, are then transmitted to a database and can be sent directly to a customer’s phone or other data management systems as required. Fewer manual inputs reduce the opportunity for error (0.3% in clinical trials) while enabling pharmacies to process more tests during operating hours. By offering such improved testing options, pharmacies are better equipped to provide their customers with accurate information and advice, enhancing their service level and reputation and building confidence and loyalty.
Embarking on a New Era in Disease Detection
The pandemic has driven rapid innovation in diagnostics, and pharmacies have an opportunity to bring their systems and processes into a new era. By harnessing existing BAW technology and applying it to disease detection through its Omnia platform, Qorvo offers a compelling new tool in accurate and rapid identification of infection, enabling pharmacists and clinicians to realize all three critical testing elements: sensitivity, specificity, and speed at low cost.
For more information, visit https://www.qorvobiotech.com.
This article was sponsored by Qorvo Biotechnologies, LLC.Disclaimer
*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.