Case study on how an easy-to-use, affordable point-of-care PCR platform delivers COVID-19 results in ~30 minutes to help a hospital run safely and efficiently.
Staff shortages due to COVID-19 have placed enormous pressure on hospitals and healthcare facilities . As beds fill up and medical workers fall ill, finding the resources to provide the critical care and services needed, especially during pandemic surges, is a major challenge. While healthcare professionals frequently work through minor ailments and discomfort, the pandemic changed things — even common, mild symptoms now mean possibly exposing people to a deadly disease. Following this shift, access to reliable testing has become an important tool in helping hospital staff to do their jobs, safely.
Rapid PCR quickly emerges as a solution for testing symptomatic staff
Williamson Medical Center (WMC) in Franklin, Tennessee is committed to keeping patients and staff healthy by using reliable testing, among other protective measures, to limit the spread of COVID-19. “Any patient or employee with COVID-19 symptoms is getting a PCR test,” shared Patti Walton, director of laboratory services and occupational health at WMC. And the PCR testing platform the medical center has come to favor over time is the Thermo Fisher Scientific Accula SARS-CoV-2 Test, which returns accurate results in approximately 30 minutes. “Everybody loves this test. It’s easy to use and very accurate,” said Walton.
Early in the pandemic, COVID-19 test supply issues and turnaround times made it difficult to deliver care safely and efficiently
Like most healthcare institutions, WMC struggled to access much needed tests early in the pandemic. Unable to get the reagents they needed to process lab-based PCR samples in house, at one point the team had to send swabs to outside testing laboratories even though they had the equipment they needed right at the hospital. “It just wasn’t manageable,” said Walton of this approach. “All of our effort was focused on finding other places that we could send tests to. It was overwhelming.”
And when the WMC laboratory staff did manage to find an alternate laboratory to run tests, it sometimes took up to 10 days to get results back. This turnaround time presented a spectrum of logistical challenges and made it very difficult to keep operations running smoothly, with workers having to stay home for over a week waiting to confirm they were safe to return.
For patients, those who were admitted and symptomatic were kept under isolation protocols until results were returned, calling on staff to rely on protective equipment that wasn’t readily available at the time. Similarly, patients who were tested in the emergency room (ER) but not admitted were sent home to quarantine and often called the hospital repeatedly for an update on their test results. “By the time results came in, patients were out of isolation. It was chaotic,” added Walton.
“A PCR test that delivered results in ~30 minutes was a gamechanger for us. We could send people home from the ER knowing if they needed to quarantine. If a patient was being admitted, we didn’t have to hold them for five to six hours waiting for an in-house test to come back. And we didn’t have to send anyone to the floor to isolate unnecessarily for seven to eight days, like was happening when we were sending tests out.”
— Patti Walton, director of laboratory services and occupational health at Williamson Medical Center
Rapid PCR provides fast, accurate results so patients can quarantine only as needed and staff can get back to work quickly
When Walton was first introduced to the Accula SARS-CoV-2 Test, she immediately recognized the value of the platform’s quick turnaround, accuracy, and small size. Ultimately, the WMC team opted to make the Accula test part of their testing workflow, solving many of the challenges the institution had been facing
“A PCR test that delivered results in ~30 minutes was a gamechanger for us,” she shared. “We could send people home from the ER knowing if they needed to quarantine. If a patient was being admitted, we didn’t have to hold them for five to six hours waiting for an in-house test to come back. And we didn’t have to send anyone to the floor to isolate unnecessarily for seven to eight days, like was happening when we were sending tests out.”
The Accula system is small and easy to use with minimal training required. These features, along with the ability to deliver accurate PCR results in approximately 30 minutes, allow healthcare workers to get tested and back to work more quickly.
“There were times when we tested 40 to 50 employees a day. We felt confident we were protecting both our patients and our workforce using an accurate PCR test with a quick turnaround time. From a staffing perspective, it saved us.”
Offering a more seamless patient experience was a definite win, however maintaining the ability to provide much needed care during such a critical time was probably the greatest benefit WMC gained from using the Accula platform. “Getting through the Omicron surge was especially challenging because this variant can present similarly to other common health issues. We were having to send people home for very minor symptoms,” Walton said. “When we had 80 COVID-19 patients on the floor and not enough people to take care of them, the Accula SARS-CoV-2 Test allowed us to bring employees back to work much quicker, on the same day. There were times when we tested 40 to 50 employees a day. We felt confident we were protecting both our patients and our workforce using an accurate PCR test with a quick turnaround time. From a staffing perspective, it saved us.”
The design of the Accula SARS-CoV-2 Test kit makes it easy to use and ensures all needed reagents and swabs are packaged together
Walton noted that another significant benefit she sees with the Accula platform is that all test components — test cassettes, swabs, buffer, and controls — are packaged as a kit. “One thing I really like about this test is that everything you need comes together. You’re not struggling trying to find swabs or buffer or needing to take extra steps to validate components.”
Walton shared that the nurses who collect patient samples like that the test relies on the use of an anterior nasal swab, which is easier to collect than more-invasive nasopharyngeal samples. Having these anterior nasal swabs included in the test kit was very helpful, and it was relatively easy for the team to build a workflow around the Accula test collection and processing for this reason. “The instructions that come with the kit are excellent, so we placed them in all the areas where collection is happening. Overall, the system didn’t require a lot of training. It’s easy to operate and everybody caught on very quickly,” she said.
WMC now has nine Accula docks on site and, during COVID-19 surges, was able to run up to 100 tests a day. While hospitals and laboratories are still navigating ongoing supply chain issues, the Thermo Fisher Scientific customer service and technical support teams have been supportive in addressing any issues and providing WMC with kits to meet the hospital’s testing needs.
The Accula platform’s low-cost and small size are ideal for healthcare institutions with limited space and budget
Williamson Medical Center is located about 30 minutes south of Nashville and has expanded in recent years to meet the community’s increasing healthcare needs. Walton has played an active role in adapting laboratory services to accommodate the increasing patient volume, and she also remains intimately connected to the needs of labs in rural community settings. Following a recent visit to a smaller hospital, she observed ongoing COVID-19 test challenges. “The lab couldn’t get reagents or kits. It’s very difficult for smaller hospitals because they might not have the budget to buy a big instrument. They want to perform PCR, but there are a lot of expenses associated with larger systems and most community hospitals have limited space,” said Walton.
“I think the biggest hurdle for rural hospitals is that they don’t even know that the Accula SARS-CoV-2 Test is out there and that they can afford it.”
The Accula platform includes a portable, palm-sized dock that plugs into a standard outlet, with a 10-second dock initiation/start-up and no data entry required. Walton says this testing platform offers a great, affordable testing solution for smaller hospitals with a limited budget and space for testing, but institutions simply don’t know what testing options are available. “Having a very small platform that is accurate, easy to use, and quick would be a gamechanger for rural hospitals. They would only need one or two docks, and the docks are not that expensive. The initial upfront costs are minimal, and the tests are cheaper than most. I think the biggest hurdle for rural hospitals is that they don’t even know that the Accula test is out there and that they can afford it,” she said.
As COVID-19 cases fluctuate over time, rapid PCR will remain a critical tool for hospital labs
Healthcare professionals expect that COVID-19 case counts will fluctuate over time, possibly like the seasonal flu. Because COVID-19 and flu symptoms overlap and treatment varies, being able to reliably confirm which virus a person has will remain critical. Walton believes PCR platforms will continue to be preferred into the future due to their superior accuracy and reliability versus antigen tests , along with institutional requirements and patient awareness. “PCR is just a better test,” she said. “We’ve seen too many false positives and too many false negatives with antigen tests. Patients might not know exactly how the technology works, but they know PCR is a better test,” she continued.
Walton sees a continued need for rapid, point-of-care PCR testing in the next phase of the COVID-19 pandemic, and for other infectious diseases such as the flu. “Most people who visit our lab want to know what we use to test for COVID-19 and I’m like, ‘You’ve got to come and look at this.’ I show them how it works, and they love it because there aren’t enough PCR options like this. A lot of the other platforms are much larger, more expensive, and complicated to operate. For a PCR platform, the Accula test is so easy and cost effective.”
Other case studies
1. Covid-19: Staff absences are continuing to stretch NHS hospitals, say leaders | The BMJ
2. JCM | Diagnostic Accuracy of Rapid Antigen Test Kits for Detecting SARS-CoV-2: A Systematic Review and Meta-Analysis of 17,171 Suspected COVID-19 Patients (mdpi.com)
Disclaimer: This Accula SARS-CoV-2 Test has not been FDA cleared or approved but has been authorized for emergency use by FDA for use by laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) of 1988, 42 U.S.C. §263a, that meet requirements to perform high, moderate, or waived complexity tests. The test is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation. This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. The emergency use of this test 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.
For Use under the Emergency Use Authorization (EUA) Only. For prescription use only. For in vitro diagnostic use.