June 7, 2021 | A new public health initiative is looking to determine whether widespread access to rapid at-home antigen tests can help reduce the spread of SARS-CoV-2, the virus that causes COVID-19. Dubbed “Say Yes! COVID Test,” the initiative launched by the Centers for Disease Control and Prevention (CDC) and the National Institutes of Health (NIH) is zeroing in on Pitt County, N.C., and Chattanooga/Hamilton County, Tenn.
During the program, Quidel’s QuickVue At-Home OTC COVID-19 Tests are being distributed to as many as 160,000 area residents free of charge, supplied through NIH’s Rapid Acceleration of Diagnostics (RADx) initiative. In late March, Quidel’s test was authorized by the Food and Drug Administration (FDA) for over-the-counter use to screen for COVID-19 at home. It allows participants to conduct testing themselves and receive results in about 10 minutes.
In addition to CDC, NIH, and Quidel, the effort includes state and local public health departments, research universities (including Duke University, the University of North Carolina, and North Carolina Central University), healthcare tech company CareEvolution, community engagement partners from the RADx Underserved Populations (RADx-UP) program, and Community-Campus Partnerships for Health.
“Reliable and widely available testing is a critical part of our efforts to stop the spread of COVID-19. Regular screening with at-home COVID-19 tests can strengthen our prevention efforts,” CDC Director Rochelle P. Walensky said in a statement.
The hope, added NIH Director Francis S. Collins, is that the program will gather foundational data that can be used to figure out how at-home tests can be used to reduce viral transmission during the current pandemic and future pandemics as well. The goal, he wrote in a blog post, is to consider the benefits of self-administered testing and “help guide other communities” as they put similar programs in place.
A recent study (doi: 10.1101/2021.03.19.21253964) backed by the NIH RADx program found that, when conducted at least three times per week, rapid antigen testing “achieves a viral detection level on par with the gold standard of PCR-based COVID-19 testing” that is processed within a lab. This finding is significant, he noted, considering the advantages of this form of rapid, self-administered testing.
“Say Yes! COVID Test” will help determine the extent to which people will accept this form of testing when it is made available to them, according to Collins, and he sees the endeavor as “an important next step” for informing testing strategies in communities across the country.
Digital Companion Tool Guides Test Takers
“Say Yes! COVID Test” is designed to see if access to rapid at-home testing (up to three times per week for a month) can significantly reduce spread in vulnerable communities. Participants have the option of ordering test kits online for home delivery or picking them up at a local distribution site.
An online companion tool, also available as a smartphone app, was developed by Michigan-based CareEvolution with support from NIH. It provides participants with test instructions, helps with interpreting and understanding the results, and delivers text message reminders.
“The core part of the digital assistant, as we’re calling it, is to recognize that performing a test at home is a new responsibility for most consumers,” Vik Kheterpal, a principal and one of the physician informaticists with CareEvolution, told Diagnostics World.
It is geared toward helping people unpack and identify all the test components, handle the procedural aspects of the kit, and interpret the test results. The technology can be thought of as a “virtual digital lab tech who is there to help out with each of those three aspects,” he added.
When the box arrives at a person’s home, it contains a QR code. After pointing a smartphone camera at that code, a welcome screen opens to explain what’s inside. From there, it guides the individual through the process of conducting the test. Pictures and text are used to explain how to swab the nostril, for example, and steps that require a specific time interval make use of a countdown timer.
One part of these tests involves a stretch of about 10 to 12 minutes where users need to leave the sample in a tube, Kheterpal explained. The first time around, it may be easier to remain patient and attentive. But after taking several of these tests, it’s easy to imagine the test takers becoming distracted by a phone call, for instance, or the dinner cooking on the stovetop.
“So we then send them a nudge,” he said, which notifies the user via text message that their test is almost ready to be read. When they click on the ping, this reminder feature brings them back to the step where they left off.
While this public health intervention and ecological experiment has been conducted under the “Say Yes! COVID Test” initiative within North Carolina and Tennessee, Kheterpal pointed out that a sub-study was conducted in Illinois and Massachusetts back in January and February to evaluate the digital tool.
The technology “has been shown in prior studies that we have conducted to be both helping in the procedural aspects and the interpretation aspects,” he said, noting that the data and feedback received helped inform the strategy of making it available more broadly.
Kheterpal also highlighted the initiative’s distribution dilemmas and innovations. Trying to reach so many households in a matter of weeks amid a pandemic poses some interesting challenges, he said.
Local distribution partners such as churches, health departments, the YMCA, and employers played a key role. Still, those options involve asking participants to leave their home, get in a car or public transportation, travel to a central site, wait in line, get the test, and return home again before putting it to use.
“One of the real innovations here was our partnership with Amazon that provided the fulfillment service,” he said. This alternative method meant “consumers got the test at their doorstep without ever leaving the comfort and privacy of their home. And that was all mediated through our platform. So we manage the inventory, storage, and fulfillment aspects.”
Much like the vaccination, there’s the scientific aspect of ensuring that the test is good and effective, he added, but the reach and accessibility of that technology is a critical aspect as well.
Research Findings Still to Come
Pitt County, N.C., and Chattanooga/Hamilton County, Tenn. were selected to take part in “Say Yes! COVID Test” based on factors such as infection rates, availability of accurate COVID-19 tracking data, the availability of local infrastructure, and existing community relationships with RADx-UP.
The rapid, self-administered testing will give the residents of Hamilton County one more way to help reduce COVID-19 spread, Fernando Urrego, interim health officer for the Hamilton County Health Department, said in a statement. Each of the test kits can support home testing three times per week for two members of a household. Those who had not yet received a vaccine and those with the highest risk of exposure were seen as ideal candidates, but anyone over the age of 8 was invited to participate.
During a May 20 media session, Pitt County Health Director John Silvernail indicated that nearly 24,000 test kits had been distributed in the county (as of May 17). Roughly 3 in 4 of those kits were distributed by the health department and community partners whereas about one quarter were ordered online and fulfilled by Amazon.
Silvernail pointed out that one of the things recognized before this initiative began is that transmission often occurred within family units, or at least within groups of people who live together. The fundamental thinking behind the study is that putting these rapid tests into home settings could help identify the source case sooner, which could, help prevent transmission within the home.
“If we prevent transmission to other family members,” he said, “then maybe we prevent transmission outside of the home as well.”
The next step moving forward will be an evaluation of the program. NIH-supported researchers at the University of North Carolina and Duke University will work with CDC and NIH to study factors such as test positivity rate, COVID-19-related illness, and hospitalizations. Researchers will be monitoring viral particles in wastewater, too, to understand viral transmission.
Data from other comparable communities that have not received widespread at-home tests will also be analyzed to help determine the overall impact of regular at-home testing.
In addition, “Say Yes! COVID Test” participants have the option to volunteer for a research study that involves a weekly survey for five weeks and monthly surveys for four months. The survey questions are intended to determine whether at-home testing has altered behavior, knowledge of spread prevention, and thoughts on vaccination.
“If self-testing is shown to effectively reduce viral spread in the selected communities, the hope is that it will lead to wider distribution and acceptance of frequent home testing across the country—ultimately providing an easy and accessible new means of stemming the spread of the virus,” noted Elizabeth A. DiNenno, an associate deputy director for surveillance, epidemiology, and laboratory sciences at the CDC.
Screening Program Benefits and Caveats
“This initiative highlights the continued importance of diagnostic testing for pandemic control, despite the recent shift of focus within both the media and the R&D space towards vaccination and treatment,” Sarah Igoe, a medical research professional at Arizona State University’s College of Health Solutions told Diagnostics World.
While not involved in the “Say Yes! COVID Test” initiative, Igoe is part of the COVID-19 Diagnostics Commons—a program at ASU designed to address the pandemic with information about testing, diagnostics technologies, and strategies for keeping employees safe as the economy reopens. She added that “rigorous screening protocols are essential for infectious disease control in a post-vaccination world” as mask and social distancing guidelines loosen.
According to Igoe, the main benefit of a global at-home testing program is to scale up screening with minimal resource cost to the individual so that infected or potentially infected people can take appropriate protective measures.
However, rapid antigen tests already have a higher false-positive rate than the gold standard PCR test, she pointed out, and the screening of asymptomatic individuals inevitably leads to even higher levels of false-positive results. Because of this, extensive counseling and education need to accompany any serial screening program to help people interpret results and determine what actions to take next.
Igoe also cautioned that individuals likely to take part in at-home screening programs could be more interested in personal and public health than their peers, “potentially confounding any insights” to be gathered from an association between participation in these types of programs and higher levels of protection from transmission.
Paul Nicolaus is a freelance writer specializing in science, nature, and health. Learn more at www.nicolauswriting.com.