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Home-Based COVID-19 Testing May Have Behavioral Consequences. A Study Wants See What They Are

NEW YORK – A trio of companies is currently undertaking an evaluation of home-use antibody tests for SARS-CoV-2 infection, with an emphasis on behavioral outcomes. Radish Health, ProofPilot, and Sanesco have set out to demonstrate not only whether people are able to safely and effectively administer their own serology testing at home, but also whether there are behavioral consequences of home testing for COVID-19.

The clinical trial began last month and is expected to wrap up in about four weeks. It has enrolled 252 participants in the New York City area to date and is using a test to detect IgG/IgM antibodies against SARS-CoV-2 manufactured by Hangzhou Biotest Biotech, distributed in the US by Premier Biotech.

New York City-based Radish Health, a boutique primary care provider of employee health services to corporate organizations, is presently performing health security advising for COVID-19 return-to-work planning, according to CEO Viral Patel. In an interview, he said that this includes access to testing, "so employees can feel safe coming back to work, when they decide to do so."

ProofPilot, also headquartered in New York City has developed a platform to design, launch, manage, and participate in longitudinal human subject research studies, or clinical trials, the firm's CEO Matthew Amsden said in an interview.

Sanesco, a CLIA high-complexity certified lab based in North Carolina, will also support the study.

The three companies chose the Premier Biotech test among the many options for antibody testing because it is packaged in a way that supports single-use testing – with everything to test one person in one package, as opposed to other tests that are not individually wrapped or provided with individual components. Also, "The reported numbers of specificity and sensitivity seem to be pretty good," Patel said. 

The test had been used in a serology survey in Santa Clara, California, and a recently-updated pre-print describing that research indicates a sensitivity for the test of 83 percent and a specificity of more than 99 percent, based on data pooled from multiple sources. Although the Premier test was recently a subject of an news article related to alarm over imported tests, that article subsequently required a correction to explain the nuances of FDA's pathway D, according to a statement from the company. The test has also reportedly been submitted to the National Cancer Institute's serology test evaluation program, which is a potential path to Emergency Use Authorization the agency has referred to as "the umbrella pathway."

The goal of the clinical trial is to determine if people can adequately perform an antibody test, with a secondary goal of understanding how the testing changes behavior. The latter outcome measure includes social behavior as well as personal psychological effects, such as changes in anxiety levels, Patel said.

Specifically, the trial will evaluate home use of the 10-minute finger-stick serology test by people who had prior confirmed COVID-19 infection, as well as people with likely infection as determined by a physician or self-diagnosed, and people who were exposed but had no symptoms.

The patients will run the test at home and their own reading of the test result will be compared to a physician determination based on a photo of the completed test. This aspect will be done by clinicians at Sanesco.

Patients will also fill out a survey on the ease of use of the at-home test.

Participants will then be tracked for eight weeks, during which time they will report on whether the testing changed their anticipated or actual social distancing behavior.

They will also use a rating scale to measure economic and personal anxieties related to testing using a modified version of an anxiety rating tool called the Zung scale.

Most of the literature on how home testing affects behavioral outcomes is related to HIV testing and other sexually transmitted infections, particularly in low-resource settings or among high-risk groups. The advantages of home-use testing were recently shown in that context, for example, with patients more frequently utilizing HIV testing when they did at-home self-tests. There are signs of increasing investment in at-home HIV testing, both in the US and internationally.

The public health concerns for active, transmissible infections like HIV are, of course, different than those for an antibody test to establish past infection.

And while SARS-CoV-2 molecular diagnostics and viral antigen tests indicate current infection, and results need to be reported to public health departments, COVID-19 serology results are not reportable.

ProofPilot was founded in 2014 around the time the FDA and CDC were evaluating the first at-home HIV testing, Amsden said. The way testing changes behavior over time was an important outcome that needed to be assessed for that type of testing to be considered safe and effective.

Amsden noted that his team has borrowed from the study designs of home-use HIV tests, but, assuming tests can be done correctly at home, the COVID-19 tests may actually be much lower risk.

"Unlike a positive HIV test result, a positive or negative COVID antibody test result is not medically relevant," Amsden said, because there is no treatment for a past infection. An HIV test, on the other hand, would require and triage to treatment, ultimate reporting to public health departments, and counseling and other attention to the mental health of people who test positive. 

Nevertheless, home-use testing for COVID-19 brings up a similar set of issues related to the way testing changes behavior after testing, Amsden said.

One question that will be explored, for example, is whether people will be nervous about going back to work because they have a positive antibody test result. Thus, the New York City clinical trial will go beyond usability to help inform employers, and others, about whether or not tests make a difference in how people behave, Amsden said.

Radish Health's Patel emphasized that it is important to show the behavioral outcomes in conjunction with usability studies, rather than as a post-market evaluation. "Everything has to be done very quickly, and we're trying to do these things in parallel," he said, adding, "Every day matters, and every day could be another life affected."

Amsden said the team intends to make the results available as soon as they come in and noted that the study is not sponsored by any device manufacturer, so it can switch devices if necessary.

The business case for the team involves providing information that will likely be in demand in the near term as the world tries to find a new equilibrium with a lingering health threat, but the team does not intend to charge for access to the data.

"We didn't see anybody doing the kinds of research studies like this – we had questions that we felt needed to be answered, and we had the capacity between the three organizations," Amsden explained. "We all felt like something needed to be done, and we couldn't find anybody else doing it."

Amsden said that in general clinical trials of home-use testing need to be more streamlined. "We need to get much better at answering these questions more effectively collectively, in a way that doesn't necessarily require millions of dollars to run these trials," he said. The NYC trial, for example, is being run on a "shoestring budget," he said.

FDA's stance on at-home testing

The FDA has now authorized a number of tests for at-home sample collection, as recently reported, and has also created a template for companies developing home sample collection tests and kits to help them submit their EUA applications.

But the agency has repeatedly emphasized that there are no tests for SARS-CoV-2 that are yet authorized to be used entirely at home.

The Hangzhou Biotest Biotech test is listed under FDA's pathway D, and is technically deemed a high-complexity test because it has yet to be reviewed by the agency. The agency has stated on its website, "Any COVID-19 test for at-home testing, with or without the use of telemedicine, requires an authorized EUA." Home collection is explicitly permissible as part of an Institutional Review Board-approved study, however.

The bar for home use infectious disease testing has been historically quite high. Only one test — OraSure Technologies' OraQuick In-Home HIV Test — has ever cleared the required US regulatory hurdles, as previously reported. There are also a few FDA-cleared collection kits on the list of home-use tests that enable home-collected samples to be tested for infectious diseases in a lab.

The current EUA endeavor could potentially change this status quo, however. The FDA has frequently mentioned that home testing is on its radar, and progress in telehealth to support patients while they take the test and interpret the results may also alter the overall dynamic. The agency has explicitly said it is "supportive of at-home testing for COVID-19, provided there is data and science to support consumer safety and test accuracy." This includes demonstrating usability — namely, the ability of a lay user to collect their specimen, run the test, and interpret their results accurately.

The FDA notes on its website that it encourages developers to discuss with it their validation of home use tests early in their development process, noting in particular that the criteria for authorization include addressing risks associated with "testing and interpreting results by a lay consumer rather than a professional."