Third round of free coronavirus testing made available by the US government
These over-the-counter products were used to diagnose an illness or to keep track of problems like high blood sugar. In recent years, however, thousands of new tests of all kinds have appeared on store shelves and online – many from companies like Everlywell, LetsGetChecked and myLab Box. Some are simple, like those for the coronavirus, but others have muddier metrics like “cellular aging.”
Regardless of their purpose, most of these products are not covered by insurance, and costs can range from as little as $10 for strips used to check urine for bacteria to $1,000 and more for certain genetic tests.
Some experts say the tests are convenient and transparent about their costs. “In a way, this trend is positive because it gives patients more choices about when and how to seek treatment,” said Jeffrey Kullgren, associate professor in the department of internal medicine at the University of Michigan Medical School in Ann Arbor .
But the quality of these home tests can vary dramatically, and some can have confusing results, lead to unnecessary follow-up and treatment, and delay the care needed, he adds.
The Food and Drug Administration has approved the marketing of about 100 categories of home medical tests. Some have been reviewed by the FDA to ensure, for example, that they can accurately and reliably measure what the manufacturer claims with the testing measures. Others may be exempt from the review, in some cases because the agency classifies them as low-risk. (To find the list of approved tests, go to FDA.gov, search for “In Vitro Diagnostic Devices,” then click Home Use Tests on the left.) Some companies advertise their products as “FDA Registered.” ‘ but that doesn’t mean the FDA reviewed them.
‘I got my life back’: New tests could help people with persistent UTIs
The most useful home medical tests might be those that help people with chronic conditions like diabetes, congestive heart failure and high blood pressure monitor their health, says Sterling Ransone, president of the American Academy of Family Physicians. Home checks of measurements like blood pressure can help people manage some medical conditions at home and save them a trip to the doctor.
The FDA has also given the green light to a handful of products used to diagnose problems like UTIs and vaginal yeast infections. And the Centers for Disease Control and Prevention recommends that people consider a quick self-test for the coronavirus before joining gatherings with people outside of their household.
If you have mild, uncomplicated symptoms, your doctor may be able to use home test results to treat you over the phone or computer. “The combination of home testing and telemedicine has given us another way to take care of our patients,” says Ransone. “I call it the 21st century home visit.”
Also useful is an FDA-approved home HIV test, which is crucial for people without access to a healthcare provider or for those concerned about their privacy. And with your doctor’s approval, you can use a home stool test to screen for colon cancer or a small blood sample to screen for hepatitis C.
A 15-minute HIV and Syphilis test – from your iPhone
Be aware of these disadvantages
Tests that the FDA hasn’t approved can have several downsides, our experts say.
Lax regulation: The FDA generally doesn’t test what they consider “wellness” tests. These are used to measure criteria such as hormone levels, food intolerance, general heart health, blood levels of vitamins, stress and cellular aging; They tend not to diagnose certain conditions.
In addition, the Agency does not typically review “Laboratory Developed Tests” (LDTs) that are developed and used by a single laboratory. But the FDA has paid attention to LDTs, identifying potential problems such as claims not supported by evidence, flawed results and falsified data in a 2018 statement.
Some home testing companies like Everlywell say on their website that their tests are LDTs. Unsure? When the FDA has reviewed a test, that fact is likely to be included in the company’s marketing materials, says Kathy Talkington, director of health programs at Pew Charitable Trusts, a nonprofit group.
Do you have bloating or hives? Don’t diagnose your own food allergy or sensitivity. Do this instead.
Shaky Evidence: Certain best-selling tests are designed to identify food intolerance by examining a user’s blood sample for IgG, an antibody in the immune system. But the American Academy of Allergy, Asthma, & Immunology advises against it due to the lack of evidence linking IgG levels to food intolerance and allergies. The FDA has also warned against at-home genetic testing, which manufacturers claim predicts how your body would respond to antidepressants, heart drugs, and other medications.
Results with little effort: Home tests for male, female, and thyroid hormones are popular. But knowing your hormone levels doesn’t necessarily reveal why you’re feeling unusually tired, for example. Numerous health conditions, including anemia, depression, infections, and sleep apnea, can all cause fatigue, Kullgren says.
Over-the-counter genetic testing, which examines the risk of Alzheimer’s, cancer and other serious diseases, is of particular concern, says George Abraham, president of the American College of Physicians. They cannot tell you if you will develop a disease or offer any advice other than to follow existing health guidelines. “It just leads to unnecessary worry and anxiety,” he says.
Keep your doctor informed
In general, our experts recommend consulting your doctor before attempting a home medical test. Some manufacturers make healthcare professionals available to recommend tests, advise users, and even prescribe medication. But they may have a vested interest in the testing company they work for, Kullgren says. They also lack the full range of information about you and your medical history. And factors like your age and the medications you take can affect the results of a home test.
A doctor who knows you will likely have a better understanding of how to tell what’s wrong than a single home medical test: “It’s like looking at a photograph,” says Ransone. “If you look at just one pixel, it’s difficult to understand the whole picture.”
Determine if the test is FDA-approved for marketing. For tests you ship, check the label or description to make sure the lab is “CAP Accredited” or “CLIA Certified.” This means that the test meets quality standards and that the laboratory is subject to regular checks.
Ask your doctor if home testing is the best way to get the information you want. “There may be an alternative approach that could help you get to the bottom of what you’re experiencing more effectively and quickly,” says Kullgren. Also, tests your doctor prescribes are usually covered by insurance; most that you can buy yourself are not.
Check storage instructions and expiration date. Some tests are sensitive to temperature and humidity.
follow instructions. Factors such as time of day, food and drink consumed, and supplements you take can affect results. Many test providers have tutorials or trained staff to guide you.
Know that no test is perfect. Coronavirus tests, which give immediate results, are generally less sensitive than those you send to a lab, and home tests for a UTI cannot detect less common types of bacteria.
And remember to talk to your doctor about results and next steps.
Copyright 2022, Consumer Reports Inc.
Consumer Reports is an independent, not-for-profit organization that works side-by-side with consumers to create a fairer, safer, and healthier world. CR does not endorse any product or service and does not accept advertising. Read more at ConsumerReports.org.