February 2, 2023 – These days, it's easy to take a COVID test at home if you might have symptoms like fever and sore throat. But if the test is negative, the subsequent step to diagnosis often means leaving the comfort of your private home.
But that would soon change. The FDA is confident that rapid home tests just like those for COVID-19 will soon be available and will even be available for influenza and respiratory syncytial virus (RSV).
The National Institutes of Health division that helped develop rapid COVID tests confirmed that it’s working with developers of combination tests that may detect multiple respiratory diseases.
Combination tests that may search for markers of several diseases are called multianalyte tests. In Europe and Australia, there are already over-the-counter tests that detect influenza and RSV along with COVID-19.
“We will be authorizing at-home flu and/or RSV tests that do multiple analyses with COVID,” an FDA official told WebMD. “I can't tell you exactly when that will happen, but we are committed to doing that.”
Enabling such a house test is consistent with the FDA's goals of improving health care equity and affordability, the official said.
Currently, the strategy of developing and applying for FDA approval of combination tests is easier and dear for developers under special pandemic rules. Developers receive extensive support from the National Institute of Biomedical Imaging and Bioengineering on the NIH, especially in the world of validation studies.
The institute has already helped develop combination tests that might be utilized in the healthcare system, says its director Dr. Bruce Tromberg.
“Some of these have form factors that look like they should be completely at-home and available over the counter,” he says. “I'm optimistic they will ultimately meet FDA performance standards.”
Tromberg calls the present situation for home testing a “paradigm shift.” His institute estimates that greater than 6.5 billion COVID tests have been produced that his organization helped develop.
“We’ll probably stop counting, the numbers are so big,” he says of the now universal COVID test.
From test tube to ubiquitous disposable product
With thousands and thousands and even billions of COVID tests having been administered, home testing has turn out to be a standard a part of American life.
“The public's expectations of medical testing have clearly changed due to the convenience, privacy and speed of getting these results at home, which is a good thing,” wrote Dr. Shannon Haymond, president of the American Association for Clinical Chemistry, in an email. She can be chief of clinical mass spectrometry at Ann & Robert H. Lurie Children's Hospital of Chicago and associate professor of pathology at Northwestern University Feinberg School of Medicine.
With pandemic culture driving demand for at-home testing, many are recalling the Nineteen Seventies era referred to as the Sexual Revolution, which focused on women's autonomy over their very own bodies. During this time, pregnancy testing shifted from clinical settings to the privacy of ladies's homes.
“I liked the phrase from an EPT ad from the '70s that it was a 'little private revolution,'” says historian Sarah Leavitt, PhD, a former historian on the NIH whose pregnancy testing timeline reads: “The thin blue line,” is one of the NIH's most popular historical publications. “It brings the pregnancy test into your privacy, you have power over it again, and it's your story and your body, and you can tell people whenever you want.”
Fifty years ago, the waiting time for the thin blue line was less than 15 minutes, which is roughly the time it takes today to find out the result of a pregnancy test or Covid test.
“One big difference is that when the primary home pregnancy test got here out within the Nineteen Seventies, testing technology was much less advanced than it’s today,” explains Haymond. “This implies that the primary home pregnancy test was very complicated to perform – it involved 10 steps and equipment equivalent to test tubes, and users had to maintain the test tubes in a vibration-free place for 2 hours. The easy-to-use stick tests we all know today weren’t developed until 1988.”
Both the COVID home test and the pregnancy test raised early concerns in the medical community about test accuracy and the potential for application error.
“In hindsight, these concerns could appear overly cautious, but this balance between innovation and caution is crucial to be sure that medical advances are all the time made with patient safety in mind,” Haymond said.
The best approach is to combine the benefits of home testing with the available expertise of health care providers who can advise on when to take a test, how to interpret the results and whether additional medical care is needed, she said.
The future of home diagnostics
Television can be a reflection of the place of science in our culture, says Leavitt.
“I've been attempting to imagine when COVID testing will start to look as a cultural marker in TV shows,” she says, noting that in addition to pregnancy tests, HIV tests and paternity tests have also found their way into the plot. “I don't know what the plot point could be – possibly the test that's present in the trash, and whose test was it?”
By the time COVID tests are on TV, the pace of technology may have already created a new focus for at-home testing. Haymond sees artificial intelligence for home diagnostics on the horizon.
“Of course, in laboratory medicine, as in just about all areas of healthcare, we expect data analytics to be one other major area of innovation and transformation,” she said. “This involves using technologies like artificial intelligence to discover patterns and trends in healthcare data sets after which using those insights to discover at-risk patients before they get sick, higher personalize tests and coverings, and improve human workflows in clinical testing and result interpretation.”
In the short term, Tromberg of the National Institute of Biomedical Imaging and Bioengineering can envision a program that would help people in rural areas — also known as “health deserts” — get tested at home and then easily connect to medical care. The institute is already supporting piloting such a program that includes at-home COVID testing and connection to treatment in Pennsylvania. He could easily envision such a program with at-home flu and RSV testing.
“People would obviously prefer to get tested at home if they may,” Tromberg says. “That's not so far-fetched, since many individuals are already taking telemedicine appointments anyway.”