By Brian Bothwell, Senior Director, Qorvo Biotechnologies, LLC
[Partner content] Senior living facilities can access clinically reliable COVID-19 testing in-house with new Qorvo Biotechnologies Omnia™ test platform and SARS-CoV-2 antigen, offering residents and staff greater peace of mind.
As the COVID-19 pandemic has illustrated, timely and accurate information is essential to fighting infectious disease and protecting vulnerable populations. Vaccines and safety precautions can go a long way toward returning society to a sense of normalcy. But there is a reason public health experts continue to promote rapid and reliable testing, particularly as new variants emerge.
Swift, accurate and accessible testing gives operators of senior living facilities vital information that impacts how they care for residents and employees to reduce the spread of disease. Up until recently, however, users 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 lab in many instances, as well as with multiple product options in point-of-care (POC) settings. Turn-around time is lengthy for central lab testing, although even PCR POC is a time-consuming testing process. Depending on demand, residents could wait several days for their results, losing precious time to protect at-risk individuals around them.
Rapid lateral flow tests, on the other hand, can provide results in as little as 15 to 20 minutes. Typically designed as antigen tests that spot viral proteins, these kits are relatively simple to use. However, they are more likely to provide false readings. The tests tend to perform best when more virus is present. One of the most worrisome aspects is they can miss mild cases or cases in which patients are asymptomatic, giving a false sense of security, which can be particularly dangerous in congregate settings with higher-risk populations. This is especially true for the most recent Omicron variant whose viral load distribution has created challenges for rapid antigen lateral flow tests.
There also remains workflow fit and error rate issues for end users. The requirement of time-read windows combined with the manual data entry associated with lateral flows creates additional challenges. Even with specific POC molecular testing options, issues associated with product designs not optimized for volume testing environments highlight the need for 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 fill the gap.
Unlike traditional diagnostic approaches that rely on optical or fluorescence detection, Qorvo uses high- frequency Bulk Acoustic Wave (BAW) sensors — tested technology used in cellphones and WiFi 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 able to measure 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 just 20 minutes, but the level of accuracy approaches that of some PCR tests, even at low viral levels. Importantly, this performance benchmark has recently been confirmed in a clinical study of suspected Omicron samples. This data suggests that the Omnia platform is a great option for senior living environments where performance is important.
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 were valid, as was the sensitivity of the detection core. The NIH’s study indicates that the Omnia platform can achieve results that are comparable to some high-sensitivity PCR testing systems, and the system’s design 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 (EUA) from the Food and Drug Administration. Also in the spring, it was awarded a $24.4 million contract from the NIH to spur production and a market launch. The award underscores the capabilities of the new system to work rapidly while providing high assurance of the veracity of results.
Easy integration in fast-paced environments
Senior living facilities conducting COVID-19 testing are doing so on top of their normal workloads, adding complexity and urgency to workflows. The Omnia apparatus was developed to fit seamlessly into the mix, 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.
Residents and employees first scan a QR code, and their testing cartridge is scanned and connected to their information. Once a nasal swab is received as a sample, it is processed in a lysis buffer tube to preserve its stability for 24 hours. Testing sites have flexibility to process tests immediately in urgent situations or in batches as their workflow permits. Results, generated in 20 minutes, are transmitted to a database and can be sent directly to a resident’s or employee’s phone, or other data management systems as required. Few manual inputs reduce the opportunity for error (0.3% in clinical trials) and automated processes allow staff to engage in other necessary tasks while tests run. By offering such improved testing options, senior living facilities are better equipped to provide their residents and employees with accurate information and to take safety precautions and action to isolate infected individuals.
Embarking on a new era in disease detection
The pandemic has driven rapid innovation in diagnostics, and senior living facilities have an opportunity to bring their 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 senior living facilities to better maintain the well-being of their populations.
*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.
