Today in the chart

The Pros and Cons of At-Home Testing for Patients: What Clinicians Should Know

The resounding message: These tests are not accurate enough for consumers to be using without medical oversight.

More and more, we see advertisements on television and social media touting at-home tests for everything from fertility to menopause, food sensitivities to genetic tests that not only reveal ancestral mysteries but also uncover health concerns.

Patients are more likely to try these tests and arrive in the office concerned about the findings. As a clinician, how can you be ready, and what should you know about at-home hormone and blood tests?

We spoke to several health professionals who’ve seen an increase in at-home testing among their patients, including allergist Tania Elliott, MD, spokesperson for American College of Allergy, Asthma, and Immunology; reproductive endocrinologist Dale Stovall, OB-GYN with Methodist Health System; and Kathy Moran, spokesperson for the American College of Medical Genetics (ACMG).

The resounding response: These tests must be more accurate for consumers to use without medical oversight.

What Tests Are Available to Patients?

The growing number of over-the-counter tests available to consumers include DNA tests, such as the popular 23andMe. This test doesn’t just promise to match your ancestry but also offers health predisposition for diseases and other traits that may run in a person’s DNA. The FDA-authorized reports are all based on a saliva sample.

Food sensitivity tests, such as EverlyWell, measure IgG levels in nearly 100 foods with just the prick of blood from a consumer’s finger. At-home pregnancy, fertility, and menopause predictors, as well as testing for common STIs, sold in big-box stores like Walmart, use urine or blood samples to help patients self-diagnose their symptoms without needing a medical practitioner.

“The most common hormone test is a pregnancy test, which provides a positive or negative result,” Dr. Stovall says. “These have been used for a long time, are very good, and have gotten even more sensitive over 30 years to predict a pregnancy accurately.”

“Not Ready for Primetime.”

Newer tests used to predict menopause, on the other hand, “are not for primetime,” he adds. “These tests use the Anti-Müllerian hormone to determine how well ovaries are ready to be stimulated for fertility injections. They think we can use this to see fertility chances, but they are inaccurate as different people have different levels. A low dose doesn’t mean earlier menopause or lower fertility rates.”

Food allergy tests are similarly misleading.

“What I am seeing are at-home IgG tests to check allergy antibodies in foods,” says Dr. Elliott. “Unfortunately, there is no evidence that if a patient has any sensitivity to a food, they have an allergy.”

Genome tests can review genes and spot mutations indicating an increased risk for certain cancers or diseases like Alzheimer’s, Huntington’s, or Parkinson’s. The FDA permits breast and ovarian cancer screenings at home using DNA tests. But the ACMG stresses that results are “increasingly complex and … must be placed in context with medical and family history to provide meaningful information.”

What To Do if a Patient Presents At-Home Test Results?

Just like when a patient shows you a diagnosis from Dr. Google, you should trust the anxiety and ask questions to find what led them to the tests in the first place.

“If a patient who is 35 is taking a test to determine menopause, I want to know what is making her think that she may need to worry about early menopause,” says Dr. Stovall. “Is she experiencing any symptoms like hot flashes and a lack of a period? Does she have a family history with a mother or aunt who went through early menopause? Once I determine the issue, I can then work on additional tests and how to manage my patient’s care.”

Talk About Their Reliability

For food allergies, explaining the reliability of the tests may help.

“Patients feel if they have an antibody for a food that it must mean they have an allergy to that food, which isn’t necessarily true,” says Dr. Elliott. “The best thing a patient should do if they’ve taken an IgG test and feel they have an allergy is to keep a food diary for two weeks. Patients should write down what they ate and if they experienced any bloating, headaches or troublesome bowel movements after eating, then sit down with an allergist or nutritionist trained to do the detective work.”

You should also highlight the issues with over-the-counter tests and how to use them properly. At-home tests are most helpful when confirming a suspicion. “If I had eggs and ketchup for breakfast and broke out in hives, then I can take the IgG test, and it may show me it was the eggs and not the ketchup,” says Dr. Elliott.

But remind them not to treat their symptoms and to continue seeking the help of a medical professional to manage the findings and correctly confirm a diagnosis.

What Should You Tell Your Patients About At-Home Tests?

First, you can inform patients that test manufacturers often claim to have evidence that they’re more helpful than harmful, but they usually lack scientific studies to back this up. It also helps to use examples.

Take genome testing, for instance. A negative result in a health trait could lead to false reassurance, while a positive trait discovered without the appropriate counseling could lead to wrong medical decisions.

“Consumers who consider participating in direct-to-consumer (DTC) genetic testing must be aware of the limited results they will receive and the types of questions they will have to anticipate in the follow-up of the results,” according to the ACMG.

You can also refer them to the appropriate medical foundation for their concerns, as many are attempting to quell the home-testing fervor by offering deeper explanations online. The Parkinson’s Foundation, for example, explains proper gene testing for the disease, including genes GBA, PARK7, SNCA, LRRK2, parkin, and PINK1. At-home kits only review mutations in LRRK2 and GBA.

And last, it hit home that at-home tests are meant to help patients, but for most, the technology isn’t advanced enough to be a final diagnosis to any medical concern.

What At-Home Tests Can You Recommend?

Of all the tests available to patients, the most reliable are hormonal tests for women.

Pregnancy tests can be up to 99% accurate, and fertility tests are reliable.

“Luteinizing hormone (LH) is typically deficient in the body but has been found to spike up to three times right before the release of an egg,” Dr. Stovall says. (Patients should use the test daily until they see the spike to know when they are ovulating.)

These same tests can predict menopause in older women. “The average age of a woman hitting menopause is 51.2 years. The closer to that age when a woman takes this test, it can indicate she is perimenopausal or menopausal,” he says.

Get Patients Involved—The Right Way

Although the technology to provide accurate results with most at-home tests is not 100 percent, manufacturers are finding consumers want more of these tests to manage their care. This is not a bad thing, says Dr. Stovall.

“This industry is going to grow over time,” he explains. “There are at-home tests for so many things, such as EKG tests, blood sugar tests — overall, these tests are good things and help get patients on board with their health.”

The problem is the discrepancy between the test’s accuracy and how much a patient trusts its resolve, leading to unnecessary anxiety or postponing seeking necessary care.

“As more research is done, we can use these tests for diagnosis, and testing can become more helpful to a patient,” Dr. Stovall adds. “It’s too early right now, but it doesn’t mean they won’t be perfected.”

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