Feb. 2, 2023 – It’s easy these days to take an at-home COVID test when you have symptoms like a fever and sore throat. But when the test is negative, the next step toward diagnosis usually means leaving the comforts of home.
But that could soon change. The FDA says it is confident that at-home rapid tests like those for COVID-19 are forthcoming for the flu and respiratory syncytial virus, or RSV.
The division of the National Institutes of Health that helped create rapid COVID tests confirmed it is partnering with developers on combination tests that can look for multiple respiratory illnesses.
Combination tests that can look for the markers of more than one disease are called multi-analyte. Europe and Australia already have over-the-counter tests that look for flu and RSV along with COVID-19.
“We will be authorizing at-home flu and/or RSV tests that are multi-analyte with COVID,” an FDA official told WebMD. “I can’t tell you exactly when that would happen, but we are eager to do that.”
Making such an at-home test possible would be in line with the FDA's goals to expand health care equity and affordability, the official said.
Right now, the process for developing and applying for FDA approval of combination tests is less complicated and expensive for developers under special pandemic rules. Developers get extensive assistance from the National Institute of Biomedical Imaging and Bioengineering at the NIH, particularly in the area of validation studies.
The institute has already helped develop combination tests that can be used in health care settings, says its director, Bruce Tromberg, PhD.
“A couple of those have form factors that look like they should be fully at-home and over-the-counter,” he says “I’m optimistic that these will ultimately meet the performance bars that the FDA has.”
Tromberg calls the current environment for at-home testing a “paradigm shift.” His institute estimates that more than 6.5 billion COVID tests that his organization helped create have been produced.
“We’re actually going to probably stop counting, the numbers are just so big,” he says of the now universal COVID test.
From Test Tubes to Disposable Ubiquity
With millions or even billions of COVID tests used, home testing is now commonplace in American life.
“The public’s expectations for medical testing are clearly being shaped differently due to the convenience, privacy, and speed of obtaining these results at home, which is a good thing,” Shannon Haymond, PhD, president of the American Association for Clinical Chemistry, wrote in an email. She is also the director of clinical mass spectrometry at the Ann & Robert H. Lurie Children’s Hospital of Chicago and an associate professor of pathology at Northwestern University Feinberg School of Medicine.
With pandemic culture propelling demand for at-home testing, many are recalling the 1970s era known as the sexual revolution, which centered on women’s autonomy over their own bodies. During that time, pregnancy testing moved from the clinical setting to the privacy of women’s homes.
“I really liked the term from, I think it was an EPT ad, from the ’70s that it was ‘a private little revolution,’” says historian Sarah Leavitt, PhD, a former historian at the NIH whose pregnancy test timeline, “The Thin Blue Line,” is one of the NIH’s most popular historical publications. “It brings the pregnancy test into your own private sphere, you have power over it again, and it’s your story and your body, and you can tell people when you want to.”
Fifty years ago, the thin blue line wasn’t a 15-minute wait, which is about the time it takes these days to see the result of a pregnancy test or COVID test.
“One big difference is that, when the first at-home pregnancy test hit the market in the 1970s, testing technology was a lot less advanced than it is today,” explained Haymond. “This means that the first home pregnancy test was very complicated to perform – it involved 10 steps and equipment like test tubes, and users had to keep the test tubes in a place free from vibrations for two hours. The easy-to-use stick tests that we’re familiar with today weren’t developed until 1988.”
Both at-home COVID and pregnancy tests drew early concern from the medical community regarding test accuracy and potential for user error.
“In retrospect, these concerns might seem overly cautious, but this push-pull between innovation and caution is integral to ensuring that medical advancements are made with patient safety foremost in mind,” Haymond said.
The best approach is one that leverages the benefits of home testing with the expertise available from health care providers, who can advise when to test, how to interpret results, and determine if any extra medical care is needed, she said.
The Future of At-Home Diagnostics
Television can be a mirror for how science finds its place in our culture, Leavitt says.
“I was trying to envision when COVID tests will show up as a cultural marker in television shows,” she says, noting that beyond pregnancy tests, HIV tests and paternity tests have found their way into plots. “I don’t know what the plot point would be – maybe the test that’s found in the garbage and whose test was it?”
By the time COVID tests show up in television, the pace of technology may have already brought a new forefront for at-home testing. Haymond foresees artificial intelligence on the horizon for at-home diagnostics.
“Of course, like almost all areas of healthcare, we in laboratory medicine are anticipating data analytics as another major area of innovation and transformation,” she said. “This involves using technology such as artificial intelligence to find patterns and trends in healthcare datasets, and then using these findings to identify vulnerable patients before they become ill, better personalize testing and treatments, and augment human workflows in clinical testing and result interpretation.”
In the more near-term, Tromberg at the National Institute of Biomedical Imaging and Bioengineering can envision a program that would help people in rural areas – sometimes called “health care deserts” – test at home and then easily be connected to care. The institute is already helping pilot such a program involving at-home COVID testing and connection to treatment in Pennsylvania. He could see a program like that easily using at-home flu and RSV tests.
“People clearly would like to test at home if they could,” Tromberg says. “It’s not such a stretch, given that many people are already having telemedicine visits anyway.”