These over-the-counter products have been used to diagnose disease or monitor problems such as high blood sugar. But in recent years, thousands of new tests of all kinds have started appearing on store shelves and online — many from companies like Everlywell, LetsGetChecked and myLab Box. Some are straightforward, like those of the coronavirus, but others have spongy scales like “cell aging.”
Regardless of their goal, most of these products are not covered by insurance and the cost can range from less than $10 for strips to check urine for bacteria to over $1,000 for some genetic testing.
Some experts say the tests are convenient and their costs transparent. “In some ways, this trend is positive because it can give patients more choices about when and how to get care,” says Jeffrey Colgren, MD, assistant professor in the department of internal medicine at the University of Michigan Medical School in Ann Arbor.
He adds that the quality of these home tests can vary widely, and some can have confusing results, lead to unnecessary follow-up tests and treatments, and delay needed care.
The Food and Drug Administration has authorized the marketing of 100 or so classes of home medical exams. Some have been reviewed by the Food and Drug Administration (FDA) to make sure, for example, that they can measure what the manufacturer claims it measures the test accurately and reliably. Others may be exempted from review, in some cases because the agency considers them low risk. (To find the list of authorized exams, go to FDA.govsearch for “in vitro diagnosis,” then click Home Use Tests on the left.) Some companies promote their products as “FDA registered,” but that doesn’t mean they’ve been reviewed by the Food and Drug Administration.
The most useful home medical tests may be those that help people with chronic conditions such as diabetes, congestive heart failure and high blood pressure monitor their health, says Stirling Ranson, president of the American Academy of Family Physicians. Home checks for procedures like blood pressure can help people manage some conditions at home, saving them a trip to the doctor.
The FDA has also given the green light to a few products for diagnosing problems such as urinary tract infections and vaginal yeast infections. The Centers for Disease Control and Prevention recommends that people consider using a rapid self-test for Corona virus before joining gatherings with people outside their homes.
If you have mild, immediate symptoms, your doctor may be able to use the results of a home test to treat you over the phone or computer. “The combination of home testing and telemedicine has given us another way to care for our patients,” Ranson says. “I call it the call of home in the twenty-first century.”
It’s also helpful to have an FDA-approved home HIV test, which is essential for people who don’t have access to a health care provider or who care about privacy. With your doctor’s approval, you can use a home stool test to detect colon cancer or a small blood sample to detect hepatitis C.
Be aware of these flaws
Our experts say that tests not approved by the US Food and Drug Administration (FDA) can have many drawbacks.
Lax regulation: The Food and Drug Administration generally does not review what it considers “wellness” tests. These are used to measure parameters such as hormone levels, food allergies, general heart health, blood levels of vitamins, stress and cell aging; They tend not to diagnose specific conditions.
In addition, the agency typically does not verify “developed laboratory tests” (LDTs), which are developed and used by a single laboratory. But the FDA has been paying attention to lab-developed test screenings, and in a 2018 statement, it identified potential problems such as unsubstantiated claims, false results, and false data.
Some home testing companies like Everlywell say on their website that their tests are LDT tests. Not sure? If the FDA did review one of the tests, that fact would likely be included in the company’s marketing materials, says Cathy Talkington, director of health programs at Pew Charitable Trusts, a nonprofit group.
shaky guides: Some of the best-selling tests are purported to identify food sensitivities by checking a user’s blood sample for IgG, an antibody to the immune system. But the American Academy of Allergy, Asthma, and Immunology advises against doing so because evidence linking IgG levels to food allergies and sensitivities is lacking. The FDA has also warned against home genetic tests that manufacturers claim will predict how your body will respond to antidepressants, heart medications and other medications.
Results with a little use: Home tests for male and female hormones and the thyroid are common. But knowing your hormone levels doesn’t necessarily determine why you’re feeling, for example, unusually tired. Colgren says many health issues, including anemia, depression, infections and sleep apnea, can cause fatigue.
George Abraham, president of the American College of Physicians, says over-the-counter genetic tests that check for risk of Alzheimer’s disease, cancer and other serious conditions are of particular concern. They cannot tell you if you will develop a disease or give advice other than following current health guidelines. “It only leads to needless anxiety and worry,” he says.
Keep your doctor informed
In general, our experts recommend that you consult your doctor before using a home medical test. Some manufacturers provide healthcare professionals to recommend tests, advise users, and even prescribe medications. Colgreen says they could have a vested interest in the testing company they work for. They also lack the full range of information about you and your medical history. Factors such as your age and the medications you take can affect the results of the home test.
A doctor who knows you will likely have a more complete understanding of how to determine what isn’t true than a single home medical test can: “It’s like looking at a picture,” says Ranson. “If you look at just one pixel, it’s hard to understand the whole picture.”
Determine if the test is authorized to be marketed by the Food and Drug Administration. For tests you submit, check the label or description to make sure the lab is “CAP Certified” or “CLIA Certified.” This means that the test meets quality standards and that the laboratory undergoes regular inspections.
Ask your doctor if a home test is the best way to get the information you want. “There may be an alternative approach that can help you more effectively and quickly get to the bottom of what you’re going through,” Colgren says. In addition, insurance usually covers doctor’s order tests; Most of those you can buy yourself are not.
Check storage directions and expiration date. Some tests are sensitive to temperature and humidity.
Follow the instructions. Factors such as the time of day, the food and drink consumed, and the supplements you take can influence the results. Many test providers have educational programs or trained staff to guide you.
Know that there is no perfect test. Coronavirus tests that provide immediate results are usually less sensitive than those you send to a lab, and home tests for urinary tract infections cannot detect less common types of bacteria.
And remember to talk to your health care provider about the results and next steps.
Copyright 2022, Consumer Reports Inc.
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