Rapid PCR delivers results in ~30 minutes, enabling same-day COVID-19 testing for surgical patients at a children’s hospital
Case study: Same-day point-of care testing helps make treatment more accessible for patients of all ages and allows healthcare systems to maintain surgical schedules
Within the first few months of the pandemic, the CDC estimated that 41% of U.S. adults had delayed or avoided medical care due to COVID-19 . The potential negative consequences of delayed care are many, with experts advising that putting off surgery, in particular, can lead to worsening medical conditions, compromised quality of life and, in some cases, even death . Children are not immune to these potentially harmful outcomes, with researchers estimating that pediatric institutions delayed or canceled more than 51,000 elective procedures from March to May of 2020 .
Delayed care can lead to worse outcomes and costs healthcare systems billions of dollars
Delays in patient care can result in significant financial burden to the overall healthcare system. From March to June of 2020 alone, the American Hospital Association estimated that canceled medical visits and procedures resulted in over $200 billion in losses for hospital and health systems , forcing some institutions to lay off a large amount of their workforce to stay open or to shut down entirely . With healthcare capacity especially critical during pandemic surges, such a reduction in resources can severely limit access to care and affect outcomes, particularly in rural settings where multiple clinic options might not be locally available.
As Children’s Hospital of Atlanta (CHOA) worked to overcome the many pandemic challenges facing hospitals and focused on restoring a normal cadence of scheduled patient procedures, care teams recognized that coordinating COVID-19 testing days ahead of scheduled procedures was posing a major challenge to some patients and families. Lab-based PCR testing was not a viable option in this setting, given the five-hour turnaround time and the need for complex equipment, specialized testing personnel and a more complex validation protocol. In an effort to overcome these logistical challenges while eliminating a potential barrier to patients and promoting timely delivery of care, the hospital sought a reliable COVID-19 test that could be administered at a patient’s bedside the same day as their procedure with accurate results delivered as quickly as possible.
Rapid PCR testing at the point of care brings convenience to pre-procedure COVID-19 tests
“We were looking for a process that was easier for families to navigate, and rapid PCR testing that could be done by nurses, in house, helped us get there.”
- Kim Faustin, medical technologist and lab team lead at CHOA
When lab-based PCR tests are used prior to surgery, patients must make a special trip to get their test done days in advance of the procedure. Timing this test can be complicated, as you need to be sure the lab will be able to return results before the scheduled procedure without allowing so much time to pass that the test result is no longer applicable. If a lab-based PCR test result is invalid, a patient will have to make another special trip for a new test. With a gap between testing and procedure day, it’s also possible for a person to become infectious between when the test is run and the procedure is scheduled.
To address these limitations, the team at CHOA chose to build a pre-procedure testing workflow using the Thermo Fisher Scientific Accula SARS-CoV-2 Test. The team’s model leveraged this platform’s rapid PCR technology which provides accurate results in approximately 30 minutes, allowing the medical staff to test patients when needed at the bedside on the same day. This approach helped CHOA eliminate the many potential roadblocks, inefficiencies and delays associated with lab-based pre-procedure testing.
Rapid PCR COVID-19 testing allows patients to be tested on the same day as their procedures and eliminates the need for extra trips to the hospital to get a test
Kim Faustin, medical technologist and lab team lead at CHOA, explains that being able to provide a better patient experience has been a major advantage in using the Accula platform for pre-procedure testing. “It was inconvenient for parents that are far from Atlanta to get a test in advance, so we wanted a solution that would allow families to come in for testing right before surgery and get everything done in one day. We were looking for a process that was easier for families to navigate, and rapid PCR testing that could be done by nurses, in house, helped us get there.”
Less invasive anterior nasal swabs are easier for staff to administer and provide comfort to young patients and their parents
Faustin also points out the benefit of the Accula test’s approved anterior nasal swab collection method, versus the more invasive nasopharyngeal swab collection. This method allows the CHOA staff to more easily test pediatric patients as young as infants with a less invasive approach. “Our teams and parents really like that the test isn’t nasopharyngeal. When working in pediatrics, patients’ noses are smaller, so it’s better for everyone that we don’t have to swab so far back to get a sample.”
Consistency enables an efficient and reliable rapid PCR testing model
Approved for use in CLIA-waived environments, the Accula system doesn’t require lab personnel or experience to process tests; it is, however, critical that instructions for use are followed every time.
“Pipetting technique is important with this test,” said Faustin. “If you don’t pipette according to the instructions, that’s when you get invalids.” Some test administrators were also veering away from instructions, thinking that rotating a sample swab in the buffer vial more than the recommended five times would lead to a more accurate result. Faustin shared the astute insight she passed along to the CHOA teams in response to this observation: “It’s PCR. If they have COVID-19, the test will pick it up.” For the Accula test, this statement has remained true with SARS-CoV-2 mutations entering the picture. Thermo Fisher Scientific has confirmed that the performance of the test has not been affected by the Delta and Omicron variants .
The Accula SARS-CoV-2 Test consists of a test cassette containing all necessary PCR components and a portable, palm-sized Accula Dock. The dock plugs into a standard wall outlet and does not require long initialization steps to begin testing, making set up easy and allowing for testing to be performed in areas where testing space may be limited or close to the patient. The compact design of the Accula platform allowed CHOA to allocate small, designated testing spaces throughout the hospital to run their rapid PCR tests. With one person collecting swabs and another dedicated to processing them, the CHOA teams can now efficiently run up to seven docks in one test setting and are able to reliably test over 300 patient samples per month.
Reliable, rapid PCR test for the detection of SARS-CoV-2 in ~30 minutes
The Accula system is small, portable, and easy to use with minimal training required. These features, along with the ability to deliver accurate PCR results in approximately 30 minutes, support the timely delivery of actionable care in a clinic setting.
To see what happens inside an Accula test cassette, watch this video that follows a patient sample from collection to results.
Rapid PCR COVID-19 testing can play an important role in delivering critical medical services during the pandemic
To promote health equity and ensure patients are able to maintain mental and physical wellness during a pandemic, the CDC’s report on delayed care highlights access to COVID-19 testing as a critical tool . As is shown by CHOA’s pre-procedure testing protocol, rapid PCR technologies that deliver same-day test results in approximately 30 minutes can effectively remove the barrier of inconvenience for patients scheduled to undergo critical procedures. Building a pre-procedure model that includes convenient, reliable testing helps providers deliver key medical services as scheduled, facilitating better health for those receiving care and allowing healthcare systems to remain available to treat patients in need during uncharacteristically turbulent times.
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5. Impact of SARS-CoV-2 Omicron variants on the performance of the Thermo Fisher Scientific Accula SARS-CoV-2 Test
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.