On March 11, 2020, the World Health Organization declared COVID-19 a pandemic. Wanting to get ahead of the curve, researchers at Wake Forest Baptist Health in Winston-Salem, NC designed a longitudinal study to monitor the pace of the pandemic and learn more about the scope and clinical representation of SARS-CoV-2, the virus that causes COVID-19. In a traditional study, volunteers interact in-person with the researchers or with laboratory staff. But with states locking down to decrease virus transmission, principal investigators John Walton Sanders, MD, MPH and David Herrington, MD needed a way to operate the study remotely and still collect data and blood samples for testing.
While looking at different systems for collecting and testing blood, Dr. Herrington read about Scanwell Health in The New York Times. He reached out to Jack Jeng, MD, Scanwell’s Chief Medical Officer, to learn more about the company and its work. Impressed by the accessibility and scalability of Scanwell’s technology, Dr. Herrington and Dr. Sanders agreed to partner with the company for their study, the COVID-19 Community Research Partnership, which began at Wake Forest Baptist Health in April 2020. By the end of 2020, the study expanded and now also includes sites at academic and community hospitals across North Carolina including Atrium Health, WakeMed, Vidant Health, New Hanover Regional Medical Center and Campbell University Osteopathic School of Medicine.
Study volunteers complete a daily questionnaire about their symptoms, possible exposures and healthcare visits and regularly test for the presence of COVID-19 antibodies using one of two at-home antibody tests – a traditional test that requires volunteers to mail their samples to a lab, and Scanwell’s test which uses a mobile app. Dr. Sanders and his team are using the results of these monthly tests to better understand whether the presence of antibodies offer protection from infection and how long they last. Antibodies may develop from past exposure to the virus or through vaccination. “There are a number of things that are appealing about Scanwell’s technology,” said Dr. Sanders. “The fact that study volunteers can test themselves and get an answer quickly is chief among them.”
Volunteers using Scanwell’s test open the app to receive video, audio and text instructions for the test. They collect a blood sample using a fingerstick, apply their sample to a test strip, add diluent to activate the test, and start a 13-minute timer in the app. After the built-in timer ends, lines appear on the strip to indicate whether antibodies are present. The app captures a picture of the test strip and computer vision algorithms ensure the image passes several quality checks before uploading it to Scanwell’s server. The image is then reviewed by Scanwell’s medical team and results are sent back to the participant and the study researchers within one to two days. “Scanwell’s test is very intuitive and [the app] comes with good instructions,” said Dr. Sanders. “Our volunteers are anxious to have an answer [about whether or not COVID-19 antibodies are present] and being able to receive a report from Scanwell so quickly has resulted in a high level of volunteer satisfaction.”
Using Scanwell’s technology, Dr. Sanders and his team estimate that about one third of North Carolinians were infected with COVID-19 prior to the availability of vaccines. These results are documented in a scientific manuscript currently under review and available on medRxiv. Although it’s still unclear whether the presence of antibodies reflect any ongoing immunologic protection, Dr. Sanders says that because of Scanwell, he and his team have one of the very few long-term, longitudinal studies of its size covering the region. “Quite frankly, we would not have been able to do this study had we not partnered with Scanwell Health,” he said. “The reason we could is a result of the tremendous convenience, ease [of use] and relatively low cost of Scanwell’s technology.”
While the study is nearing the end of enrollment for new adult volunteers, many of those participating will continue to test for antibodies through the summer until October 2021. Enrollment for pediatric volunteers, ages 17 and under, is underway and those volunteers will test for antibodies through September 2021.