Third round of free coronavirus tests made available by the US government
These over-the-counter products have been used to diagnose disease or monitor problems such as high blood sugar. In recent years, however, thousands of new tests of all types have started appearing on store shelves and on the internet, many from companies such as Everlywell, LetsGetChecked and myLab Box. Some are simple, like those of the coronavirus, but others have more squishy measurements such as “cellular aging.”
Regardless of their purpose, most of these products aren’t covered by insurance, and the cost can range from under $10 for strips to check urine for bacteria to over $1,000 for some genetic tests.
Some experts say the tests are convenient and their costs transparent. “In some ways, this trend is positive because it may give patients more options about when and how to seek care,” says Jeffrey Kullgren, associate professor in the Department of Internal Medicine at the University School of Medicine. University of Michigan at Ann Arbor.
But the quality of these home tests can vary widely, and some can have confusing results, lead to unnecessary follow-up testing and treatment, and delay needed care, he adds.
The Food and Drug Administration has licensed approximately 100 categories of home medical tests for sale. Some have been reviewed by the FDA to ensure, for example, that they can accurately and reliably measure what the manufacturer claims as test measurements. Others may be exempt from review, in some cases because the agency considers them low risk. (To find a list of authorized tests, go to FDA.gov, search for “in vitro diagnostics,” then click Home Use Tests on the left.) Some companies tout their products as “FDA-registered,” but that does not mean the FDA has reviewed them.
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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 Sterling Ransone, president of the American Academy of Family Physicians. Home checks of measurements such as blood pressure can help people manage certain conditions at home, saving them a trip to the doctor.
The FDA has also given the green light to a handful of products to diagnose issues like urinary tract infections and vaginal yeast infections. And the Centers for Disease Control and Prevention recommends people consider using a rapid self-test for coronavirus before joining gatherings with people outside their household.
If you have mild, simple symptoms, your doctor may be able to use the home test results 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,” Ransone says. “I call it the 21st century home call.”
An FDA-approved HIV home test is also helpful, essential for people who don’t have access to a healthcare provider or are concerned about privacy. And with your doctor’s approval, you can use a home fecal test to screen for colon cancer or a small blood sample to screen for hepatitis C.
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Be aware of these disadvantages
According to our experts, tests that the FDA has not approved can have several drawbacks.
Lax regulation: The FDA generally does not review what it considers “wellness” tests. These are used to measure criteria such as hormone levels, food sensitivities, general heart health, blood levels of vitamins, stress and cellular aging; they tend not to diagnose specific conditions.
Also, the agency generally does not verify “laboratory-developed tests” (LDTs), which are developed and used by a single laboratory. But the FDA paid attention to LDTs, and in a 2018 statement identified potential problems such as claims not supported by evidence, spurious results, and falsified data.
Some home testing companies such as Everlywell indicate on their website that their tests are LDTs. Uncertain? If the FDA has reviewed a test, that fact will likely be included in company marketing materials, says Kathy Talkington, director of health programs for Pew Charitable Trusts, a nonprofit group.
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Trembling proof: Some best-selling tests purport to identify food sensitivities by checking a user’s blood sample for IgG, an immune system antibody. But the American Academy of Allergy, Asthma, & Immunology advises against this because evidence linking IgG levels to food sensitivities and allergies is lacking. The FDA has also warned against home genetic testing, which manufacturers say will predict how your body would react to antidepressants, heart medications and other medications.
Results with little use: Home tests for male, female and thyroid hormones are popular. But knowing your hormone levels does not necessarily determine why you feel, for example, abnormally tired. Many health conditions, including anemia, depression, infections and sleep apnea, can all cause fatigue, Kullgren says.
Of particular concern are over-the-counter genetic tests that screened for risk of Alzheimer’s disease, cancer and other serious illnesses, says George Abraham, president of the American College of Physicians. They cannot tell you if you will develop an illness or give you advice other than to follow existing health guidelines. “It just creates unnecessary worry and anxiety,” he says.
Keep your doctor informed
In general, our experts recommend consulting your doctor before using a home medical test. Some manufacturers make medical professionals available to recommend tests, advise users, and even prescribe medications. But they may have a vested interest in the testing company they work for, Kullgren says. They also lack all information about you and your medical history. And factors such as your age and the medications you take can affect the results of a home test.
A doctor who knows you will probably be able to identify what’s wrong better than a simple home medical exam: “It’s like looking at a photograph,” says Ransone. “If you only look at one pixel, it’s hard to understand the whole picture.”
Determine if the test is cleared for sale by the FDA. For tests you send, 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 inspections.
Ask your doctor if home testing is the best way to get the information you want. “There might be an alternative approach that might help you get to the bottom of what you’re going through more effectively and quickly,” says Kullgren. In addition, tests ordered by your doctor are usually covered by insurance; most of the ones you can buy yourself are not.
Check storage instructions and expiration date. Some tests are sensitive to temperature and humidity.
Follow the instructions. Factors such as the time of day, the foods and drinks you eat, and the 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 that provide immediate results are generally less sensitive than those you send to a lab, and home tests for a urinary tract infection cannot detect less common types of bacteria.
And don’t forget to talk with your healthcare provider about the results and next steps.
Copyright 2022, Consumer Reports Inc.
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