Recent news feeds are packed with consumer tips for navigating the abundance of at-home medical tests. Within the past month, Healthline, Fortune, Self Magazine, and the New York Times, to name a few, have published articles on “best of” medical tests for a range of health conditions, from herpes and HIV to COVID-19 and thyroid function.
At-home medical tests are a booming market, expected to reach $9.5 billion by 2031. It’s no surprise given their accessibility (available online or at local shopping centers), relatively low cost, and quick results. There is an impressive selection of well-established and start-up companies offering a vast array of tests for heart health, thyroid function, colorectal cancer, and chronic kidney disease, to name a few. What’s more, the tests are portable. We can use them where we’re at with as much privacy as we choose.
Health consumers can now take charge of their health without waiting for signs of illness or an opening in their physician’s schedule, allowing for early disease detection and better overall health outcomes.
Over half of the U.S. population copes with at least one chronic disease. At-home medical tests can provide substantial insight into these illnesses and support ongoing care. Many chronic diseases require regular laboratory tests. According to the CDC, 70% of medical decisions depend on these test outcomes. By putting tests in the hands of patients, frequent trips to testing sites can be eliminated, which is a necessary and long overdue support for vulnerable populations, such as rural communities that are medically underserved, older adults, people with disabilities, and barriers related to systemic racism.
Even in areas with better health coverage, Americans experience long waits for care. According to a 2022 AMN Healthcare Survey, the average wait time for a new patient appointment is 26 days. Appointment waits for cardiology and OB/GYN are longer, at 26.6 days and 31.4 days, respectively. Testing from home keeps health treatment plans on track while closing gaps in barriers to care.
However, despite their numerous advantages, popularity, and marketing hype, at-home medical tests are far from the easy fix we all would like.
One of the most critical issues with at-home medical tests is that a unified set of standards and protocols does not exist. This lack of regulation has resulted in the development of non-validated and unscientific testing methods that do not accurately provide information about the health condition in question.
The U.S. Food and Drug Administration (FDA) generally does not review wellness tests for biomarkers such as hormone levels and allergy-related antibodies for food sensitivities. A quick search of the FDA medical device database confirms this. Many popular at-home medical tests are not FDA-approved, leading to inaccurate and unreliable results that can skew patients’ health care decisions.
For example, some at-home testing brands claim to determine tolerance and sensitivity levels for over 640 food items by analyzing just a couple of hair strands. However, no scientific study has validated hair testing as an accurate method for determining food sensitivity and allergies. Ultimately, such tests put health consumers at risk of false results and unnecessary or misguided dietary changes.
Another major disadvantage of at-home medical tests is the need for more clinician support and guidance regarding health care decisions related to test results. Many testing companies lack the adequate clinical support required to analyze and interpret test results. This often leads to inappropriate and possibly even dangerous health decisions related to a single data point. Clinician guidance is necessary so that lab testing can be viewed as part of an individual’s whole health picture.
FDA recommendations on at-home tests strongly encourage regularly consulting with health care providers regarding lab test interpretation. Other reputable sources, such as Medline and Healthline, offer similar advice. However, the 2022 University of Michigan National Poll on Healthy Aging revealed that only half of all respondents 50 to 80 years old who purchased an at-home health test other than COVID-19 had shared test results with their health care providers. Such an omission is a missed opportunity for patients to discuss health concerns and next steps with their health care team. Better education of health consumers is needed to encourage data sharing and improve health outcomes.
The bottom line is that at-home medical tests are here to stay. Many Americans purchase these tests and use their results to make personal health care decisions. These tests can potentially provide valuable information to the health consumer while closing the gap in health care access. Still, improvements must be made with this relatively new process, specifically regarding regulation and clinician oversight, before it becomes a successful mainstay of the health care landscape.
Aneesha Dhargalkar is an emergency medicine physician. Deanna Lernihan is a public health professional.
