August 23, 2023—WASHINGTON, DC | Public health agencies have grappled with a succession of data problems associated with the COVID-19 pandemic, most notably how to accurately track prevalence rates when people are self-testing in the privacy of their home and don’t necessarily need or want to report the results. The current remedy being investigated by the National Institutes of Health (NIH) is a home “test to treat” approach set to make a nationwide rollout by this October, according to Andrew Weitz, Ph.D., program director of the National Institute of Biomedical Imaging and Bioengineering (NIBIB).
Weitz was making a keynote presentation on data modernization and treatment opportunities around home testing this week, helping to open Next Generation Dx Summit 2023 in Washington, DC. He leads the digital health strategy for the Rapid Acceleration of Diagnostics (RADx) Tech initiative and is the brains behind the RADx Mobile At Home Reporting through Standards (MARS) program as well as the MakeMyTestCount.org website, which facilitates standardized test results reporting from over the counter (OTC) diagnostics.
A COVID-era newcomer to the diagnostic testing space, Weitz says he is “a byproduct of the point-of-care [POC] testing innovation” ushered in by the pandemic. While the NIBIB is one of the smaller institutes of the NIH, it has had a major impact in recent years through the RADx program that has received more than $1.5 million from Congress to speed the development and commercialization of POC and home-based diagnostic testing for COVID-19.
The return on that investment has included the production of more than seven billion tests for the U.S. home market, 55 at-home tests authorized by the Food and Drug Administration (FDA), and support for more than 100 organizations as well as the first OTC test for home use, he reports.
In the early days of the pandemic, people would sometimes go to their favorite web tracker to get a read on how COVID cases were trending in their area and decide whether to mask up or isolate. But after the first SARS-CoV-2 antigen tests became available, the amount of testing happening in the home setting began to escalate and, in October 2021, finally surpassed what was occurring in labs and in POC settings, says Weitz.
It became quickly apparent that people would need to report their own COVID test results so public health agencies would have insights into infection levels around the country, he continues. The FDA, for its part, included a clause in its emergency use authorization letter telling test manufacturers they would need to develop a smartphone app or website enabling customers to voluntarily report their results to public health authorities.
Unfortunately, the agency offered no guidance to manufacturers regarding what data elements to capture in addition to test results, where to send those data, or how to represent those data in a standardized way, Weitz says. This was partly because more than 60 different state and local public health agencies around the country were serving as collection points for test results from different groups of individuals, and “it was not practical to expect every OTC test manufacturer out there to develop an individual IT connection with each of these jurisdictions.”
RADx MARS was developed to address confusion in the OTC testing market and enable companies to streamline solutions for capturing and reporting home COVID test results, he explains. “In this program we worked directly with many OTC test manufacturers, guided them through the process of developing apps to capture and transmit these data to public health agencies, and in doing so we standardized the data elements [e.g., age, address, and zip code] that should be captured along with the test result.”
At the same time, RADx MARS promoted the use of data hubs that would automatically route results from the mobile application of a test manufacturer to the correct public health jurisdiction of test-takers, says Weitz. This required a set of standard specifications (HL7V2 and FHIR) for representing the test results digitally that was natively compatible with the information systems being used by the different state and local agencies. Close to 20 test manufacturers have adopted the RADx MARS standard.
But as time went on, people became so familiar with how to run these tests that they stopped installing and using the smartphone apps guiding them through the process, he adds. That meant they also lost the ability to report their home COVID test results.
So, Weitz and his team developed the MakeMyTestCount website. Test results generated by any authorized OCT test for home use can be reported in seconds by clicking a button and inputting the required information.
“It was one thing for us to develop this website,” Weitz says. “It was another thing, and it still is, to grow awareness about this.” NIBIB is now partnering with test manufacturers to “grow our footprint,” he adds, and one way is by providing a link to MakeMyTestCount.org in their instructions for use to meet the FDA’s home test result reporting requirement.
Public health departments can likewise enable capture of home test results, he notes. In partnership with BIBIB, for example, the Alleghany County Health Department in Pennsylvania has developed a white label version of the MakeMyTestCount website to replace a reporting portal it had built from the ground up to capture data from residents. One of the appeals of this tactic is that it comes with customized guidance connecting people to local sources if they test positive.
Moving forward, the plan is to include data visualizations and other data metrics on the MakeMyTestCount website showing people how much data has been captured and current trends, and to help get data from home tests to public health agencies, Weitz says. The much more challenging problem, given the fragmented nature of the nation’s health system, is pushing those results to primary care providers in a standardized way.
One potential solution is to use smart health cards, embedding test results in QR codes that could be scanned to get the information into a personal health record app such as Apple Health. Those results could then potentially be pushed to the electronic health records held by healthcare providers.
Multiplex reporting will be a reality this fall for at-home tests for COVID, influenza, and possibly respiratory syncytial virus, he adds, noting that the ability to report flu test results through MakeMyTestCount was already added about a week ago. But the more critical step will be connecting people to care, which is where the test-to-treat approach is coming into play.
The test-to-treat concept is to enable individuals to be tested, see a healthcare provider, receive a prescription for treatment, and have that prescription filled “all in one location,” Weitz says. In March of 2022, the Biden administration rolled out a nationwide test-to-treat program enabling individuals to go to retail pharmacy locations for COVID testing and, if they’re positive, walk out of the store with their treatment in hand.
But as indicated by a map of test-to-treat sites around the country, access is highly variable. While some people need to drive no more than 30 minutes each way, those living in rural areas might end up traveling four hours both to and from the nearest pharmacy location, says Weitz, highlighting one of the key challenges of the bricks-and-mortar version of the test-to-treat approach. Safety is likewise an issue, since people making the trip to these sites for treatment could potentially infect others.
Considering those challenges, the RADx program is researching a twist on the concept whereby individuals can go through the entire test to treat process without ever having to leave their home, he continues. This is being accomplished by leveraging home COVID testing as well as telehealth for receiving care, online pharmacies for filling their prescriptions, and shipping carriers to bring oral antivirals to their door.
What sets the program apart from similar programs offered by industry is both the approach and rationale for doing it, he says. “We want to make sure resources for this home test to treat program are available to vulnerable [medically underserved] populations” as well as compare results with those obtained via bricks-and-mortar test to treat methods in terms of treatment speed, consumer preferences, patient outcomes, and sustainability with or without government support.
Implementation science approaches are being used to run the program and best practices in electronic medical records management are being leveraged, says Weitz. In fact, one major goal of the program is to enable telehealth encounters to be captured in a standardized way and then shared with individuals’ own primary care provider.
The NIH study is being conducted in partnership with the Administration for Strategic Preparedness and Response, the Centers for Disease Control and Prevention, eMed (telehealth provider), and the UMass Chan Medical School that is doing all the research analysis. In January, it launched as a small pilot in Berks County, Pennsylvania, and last week the program was made available in the greater Atlanta and Houston areas, he says. Anyone in those regions can sign up, for free, on the test2treat.org website in advance of the nationwide expansion in another few weeks.
Healthy individuals have been encouraged to enroll and request to have tests shipped to them at no cost, which they can then opt to take if they start to feel symptomatic, Weitz says. If they do so, they are encouraged to report the results using the RADx MARS standard to their local health department.
Individuals testing positive will also be given a telehealth consultation, either via video or where the telehealth provider reviews their results offline, he adds. As an outcome of that consultation, the provider may prescribe an antiviral such as Paxlovid that can then be shipped to the patient overnight from an online pharmacy, or the patient can pick up at their local pharmacy.
Participants will be monitored and asked to complete surveys and interviews so investigators can understand the patient experience in this type of program, he says. Since this is a technology-heavy solution and some of the people most in need of intervention may not have a smartphone and internet access, an 800 number is also available for people to call to perform the home test to treat steps.
Beyond equitable access to tests and treatments, says Weitz, “the next big thing” is combination COVID and flu testing. “We’re looking at including these tests in the program when we go national,” with anyone testing positive for the flu getting an antiviral flu medication shipped to their home.
Ensuring continuity of care is important, especially when talking about telehealth, he says, so efforts are underway to ensure telehealth providers understand patients’ prior medical history and that records of virtual encounters get sent to their primary care providers—perhaps facilitated by individuals’ personal health records enabling them to “capture, visualize, and share their health data on their smartphones.”
Among the key insights learned in developing these home diagnostic workflows during the pandemic is that many individuals empowered to self-report their home test results will voluntarily do so, says Weitz. More than 12 million results from OTC COVID-19 tests have been reported since the beginning of 2021, he notes, and the numbers have moved in parallel with the volume of COVID cases.
Most home test results are still being reported from mobile apps, but the share of data captured by the MakeMyTestCount website has been growing recently and closing in on about 100,000 such reports, Weitz says. And, since the data being captured has been standardized, it can be aggregated and analyzed.
Weitz says he is most excited by the future possibility of using this “brand new” type of self-reported data from home testing to benefit public health surveillance and response. To that end, NIBIB is now developing a tool for state and public health agencies to get better insights into their own OTC testing data.
Since the early days of the COVID-19 pandemic, he points out, prevalence rates based on OTC self-testing have followed similar trends as laboratory and POC testing. “What this is telling us is that we can draw insights from... home testing data and [potentially] use them for public health response.”