For decades, diabetics have tested their blood sugar levels at home, and women have tested for pregnancy at home. But COVID-19 brought self-testing into the homes of most Americans. Certainly, the widespread use of these fast, convenient COVID tests showed us the benefits of at-home medical tests, including the ability to skip a potentially expensive, time-consuming trip to the doctor or lab. And the ever-expanding range of personal at-home medical tests allows us to measure our health in ways that were once only available by going to a doctor. But can you trust at-home medical tests?
What kinds of at-home tests are available?
There is an ever-growing list of tests available for at-home use, including tests for:
- Blood sugar.
- Folic acid.
- Food sensitivities.
- Hepatitis B and C.
- Irregular heartbeats.
- Metabolism – checking levels of TSH, cortisol, and testosterone.
- Predicting ovulation.
- Sexually transmitted diseases, including HIV.
- Stress hormones.
- Urinary tract infections.
- Vitamin D.
Additionally, you can buy tests for a microbiome analysis or a whole-genome sequencing.
Interestingly, millions of Americans have used 23andMe’s FDA-approved spit tests to get insights about their genetic predispositions to conditions ranging from breast cancer to food sensitivities.
Realize these testing companies are in the money-making business. In fact, the US home diagnostics market was valued at more than $5.4 billion in 2020. Moreover, it’s expected to reach $8.5 billion by 2030. Given the billions of tests used at home for COVID-19 testing, I’m guessing these numbers may be lower than reality.
There are two categories of at-home tests.
To clarify, there are two kinds of tests patients can use at home.
With “point-of-care” tests, the whole process occurs in your home. You take the test at home and get your results soon thereafter. There is no medical oversight or involvement. Examples of this type of testing include COVID-19 antigen tests, pregnancy tests, and blood sugar tests for diabetics.
On the other hand, with “at-home diagnostic tests” (also called “direct to consumer tests”) you collect your sample at home, then you mail the test to a lab where technicians process the results. These tests allow us to get laboratory analysis without having to visit a healthcare facility.
Typically, if the results indicate a medical issue, the testing companies connect you to a doctor to discuss next steps. However, I suggest you speak with your own doctor if you have any questions or concerns.
Home testing can improve access to care.
Unfortunately, many people do not have access to quality health care, which can lead to significant health disparities. For instance, patients may not have health insurance, may lack transportation, or may live in areas lacking medical providers. Others may have health conditions that make trips to the doctor very difficult. This lack of access is particularly difficult for people with chronic conditions that require ongoing monitoring and treatment, such diabetes, hypertension, and COPD.
Providing a way for patients to test themselves at home can make it easier for patients, and their doctors, to monitor any changes in their health. Importantly, remote testing, combined with telemedicine appointments, can help patients who cannot physically attend medical appointments receive quality care to help them manage chronic conditions.
Are at-home medical tests regulated?
If you’re wondering if you can trust at-home medical tests, your concerns may be warranted. The US regulatory system has gaps that can allow unreliable tests to stay on the market. But it’s not the wild west with no oversight at all.
The FDAs regulatory role.
The US Food and Drug Administration (FDA) oversees devices intended for the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, to ensure the devices are reasonably safe and effective.
However, if an at-home diagnostic test is designed, manufactured and used in a single laboratory, the FDA categorizes the tests as “laboratory developed tests” or LDTs. Currently, LDTs are not regulated by the FDA, as long as the tests come from laboratories that meet certain compliance criteria.
Simply put, many at-home tests don’t require FDA approval.
Importantly, popular testing companies Everlywell, LetsGetChecked, Carbon Health, and Nurx are not listed in the FDA’s database of agency-approved at-home tests.
Wondering why the FDA doesn’t regulate LDTs? Because LDTs were originally relatively simple tests, available on a limited basis, such as a test for Vitamin D in a hospital lab. But now, LDTs are widely available, often complex tests, which in my opinion, require FDA oversight.
If you’re interested, you can search the FDA testing database to learn if a test is FDA approved.
Laboratory oversight by the Clinical Laboratory Improvement Amendments.
The Clinical Laboratory Improvement Amendments (CLIA) regulate laboratory testing. Labs cannot accept human samples for diagnostic testing until they receive certification from the Center for Medicare and Medicaid Services (CMS). Also, CLIA certifies analytical validity by analyzing the accuracy, precision, analytical sensitivity, and other performance characteristics.
If a lab uses a test system that doesn’t have FDA clearance or approval (such as a laboratory developed test for at-home diagnostics), the laboratory cannot release any test results until it meets certain CLIA performance characteristics.
Note there are 3 federal agencies responsible for CLIA: The FDA, CMS, and the Centers for Disease Control and Prevention (CDC).
Can you trust at-home medical tests?
Clearly, it’s critical that at-home tests are accurate, so patients do not receive unnecessary treatments or experience delays in needed treatments.
So, can you trust at-home medical tests? Unfortunately, the answer is maybe.
Although at-home pregnancy tests are accurate 99% of the time, other at-home tests are less successful or unproven. Importantly, it can be hard to tell which tests are legitimate, according to Dr. Patrice Harris, president of the American Medical Association.
Moreover, in some cases, a proper analysis of test results must consider factors like patient’s age, family history, or other health issues.
The FDA expresses serious concern.
The FDA cautions that laboratory developed tests may overpromise and under-deliver, potentially giving customers incorrect results. Importantly, the FDA has identified problems with several high-risk LDT companies, including:
- Claims that are not adequately supported with evidence.
- Lack of appropriate controls yielding erroneous results.
- Falsification of data.
Furthermore, the FDA is concerned that people could start unnecessary treatment, or delay or miss treatment for a health condition, all of which could result in illness or death.
Importantly, the FDA is aware of faulty LDTs that could have caused the following:
- Patients being over- or undertreated for heart disease.
- Cancer patients being exposed to inappropriate therapies or not getting effective therapies.
- Incorrect diagnosis of autism.
- Unnecessary antibiotic treatments.
- Exposure to unnecessary, harmful treatments for certain diseases, such as Lyme disease.
What about tests requiring patients to draw blood?
Some at-home medical tests require patients to prick their fingertip to draw blood, which patients then transfer onto a paper card. Patients then send their samples, called dried blood posts (DBS), to a lab for testing.
Interestingly, there are many uses for DBS card testing, including tests for cancers, allergies, infectious diseases, fertility markers, comprehensive metabolic panels, and sexually transmitted disease.
Can you trust the results of at-home blood tests? Importantly, DBS card testing can be slightly less sensitive due to the small amount of blood available for testing. However, researchers report success in using DBS samples to detect diseases like HIV, Hep B and C, or COVID-19 antibodies.
The controversy over at-home tests for food sensitivities.
A best-seller for the testing company EverlyWell is a test for food sensitivity. Their website says it can gauge whether a person’s immune system is active against 96 common foods. The test analyzes a finger prick of blood to identify the presence of an immune protein called immunoglobulin G (IgG).
Their website states that a higher-than-normal IgG reactivity level can mean that there’s a possibility that food can be causing symptoms. They also clearly state that it does not test for food allergies, lactose intolerance, or celiac disease.
However, for years doctor groups have advised against using IgG tests to evaluate for so-called food sensitivities or intolerances. Moreover, allergy experts state the test is useless at best and could even cause harm if it leads customers to unnecessarily cut nutritious foods from their diet. And a 2008 European Academy of Allergy and Clinical Immunology task force recommended against testing for a type of IgG to evaluate for food intolerance.
Importantly, their IgG tests, and similar tests made by competitors, are considered LDT tests and are therefore not regulated by the FDA.
Will your at-home medical test information remain private?
Clearly, your privacy is guaranteed if you use a home test that provides an immediate answer, like a pregnancy test. However, if you must mail in your test to learn your results, is your information, including your results, protected and kept private?
As you may know, HIPAA (the Health Insurance Portability and Accountability Act of 1996) is a federal law that supports “national standards to protect sensitive patient health information from being disclosed without the patient’s consent or knowledge.”
But HIPAA compliance is only required of businesses that take health insurance. Therefore, if you use a testing service that doesn’t accept insurance, they may not be HIPAA compliant. However, that doesn’t mean they must not take steps to protect patient data. In fact, laws require these not-covered entities ensure the products or services don’t compromise patient privacy.
If you are concerned that leaked test results could cause you harm, ask the testing company what steps they take to ensure patient privacy – before you mail in your test!
Should you use at-home medical tests?
It seems you can trust some at-home medical tests, while others are unproven. Given that it is hard to know which tests are trustworthy, I strongly recommend you discuss your use of at-home medical tests with your doctor before you purchase a test. And if you decide to use an at-home test, discuss the results with your doctor.
Of course, even with the abundance of home tests available, you still need to have a relationship with your doctor and attend in-person appointments as needed.
Lastly, keep in mind there are dangers associated with unneeded tests and treatments. For more information, read The Dangers of Too Many Medical Tests and Treatments.