With Home Testing, Consumers Take Charge of Their Health
You can reap the benefits of home testing—convenience, privacy, control—as long as you educate yourself about the potential tradeoffs.
If you’ve been to the drugstore lately, you may have noticed an increase in the number of medical tests you can use in the privacy of your own home. Advances in testing technology—and changing attitudes towards patients’ responsibility for their own health care—have made home testing a worldwide, billion-dollar-and-growing market. In fact, the word “patient” itself is gradually disappearing—people like you, who used to think of themselves as patients, are now hearing themselves called “consumers” who are taking charge of their own health care.
“People today aren’t satisfied with just being told “everything’s fine,”” says James H. Nichols, PhD. “They want to know the exact number [on a test result] and what it means.”
Nichols, who directs the clinical chemistry laboratory at Vanderbilt University’s School of Medicine, says you should still be cautious when purchasing over-the-counter tests—sometimes there are tradeoffs between convenience and quality.
“Tests you buy in your local supermarket can be of similar quality to what we perform in the hospital at the bedside,” Nichols says, “but not necessarily equivalent to the quality of testing performed in a laboratory.”
Nurses, EMTs, and laboratorians must be trained and certified in the testing procedure, the instrumentation used to perform the test, and quality control practices. There is no such requirement for consumers who purchase home tests, even the ones prescribed or recommended by their doctors.
Yet these tests, especially those designed to monitor diseases like diabetes, are important to your quality of life if you live with chronic illness. Home glucose testing, for example, allows you to monitor your blood sugar level and adjust diet or medication accordingly, without having to make frequent lab visits or risking precarious highs and lows in blood sugar levels.
Home testing offers many benefits, to be sure. But it’s also important to recognize the potential tradeoffs between quality and convenience and take steps to protect yourself against bogus tests, the possibility of false results, and your own lack of training.
About Home Testing
Tests Available for Home Use
Home tests can be used to screen for, diagnose, or monitor disease. Most are available over-the-counter (OTC) in local supermarkets or pharmacies or directly from manufacturers by Internet, phone, or mail order, although a few home tests must be prescribed by a healthcare practitioner (for example, those that monitor anticoagulants).
There are a variety of tests cleared by the U.S. Food and Drug Administration (FDA) for home use. Some are used for screening, such as pregnancy tests, hepatitis C tests, drug tests, or fecal occult blood testing for colorectal cancer. Others are monitoring tests, such as cholesterol tests, prothrombin time for blood-thinning and clotting, and blood glucose for diabetes.
Some home tests, like those for pregnancy or blood glucose, produce immediate results. Others are sold as collection devices—you use the device to collect a specimen (for example, urine or stool) and then mail the device containing the sample to the laboratory for evaluation. For example, there are currently two FDA-approved home tests for HIV, the virus that causes AIDS. One test provides results at home within 20 minutes. The second test requires you to collect a small blood sample by pricking your finger at home and collecting a drop of blood on special filter paper that is then sent to a laboratory for analysis.
Home collection kits that are mailed to a laboratory for analysis include allergy tests for home allergens, hepatitis C, microalbumin for kidney disease screening, TSH for thyroid function, paternity testing, and PSA testing to screen for prostate cancer.
Test results are generally available within a week or two of mailing the specimen to the analyzing laboratory.
- To search for information on a particular OTC test (by test name, manufacturer, or test type), visit the FDA’s Office of In Vitro Diagnostic Device Evaluation and Safety
- FDA: Home Use Tests
- FDA: How You Can Get the Best Results with Home Use Tests
Convenient, Timely, but Not Necessarily Perfect
Although home tests offer convenience, privacy, and “real-time” results, those results are for your personal information. They do not qualify as official test results that could be recorded in your medical record or be acted on by a healthcare practitioner. Results that are used for medical decision-making, and recorded as part of your medical history, must be performed by a laboratory or medical professional. Therefore, your healthcare provider is likely to repeat the test that you’ve already done at home before acting on the result.
Errors can arise with any type of home test because of a number of possible mistakes. These range from using an expired test kit to improper storage to errors in how you perform the test. Mistakes in the testing procedure often involve how you collect the sample, the time of day you collect it, or how precisely you time the test (not waiting long enough or waiting too long before reading the result). Even the impact of medications you may be taking may interfere with the results and may be a source of error to be considered.
With the possibility of these various errors, your healthcare practitioner will most likely want to confirm the result of a home test to ensure its validity before proceeding with any course of action or treatment. While some follow-up procedures from erroneous home test results can be viewed simply as inconvenient, others may be costly or have serious implications. That’s why a healthcare provider will often choose to repeat even a seemingly straight-forward home pregnancy test.
“Many times, results from pregnancy tests may be invalid,” Nichols says. “This is usually because people make mistakes in performing the test.” Studies have found that one in four women misread traditional, line-based pregnancy tests, where the user evaluates the appearance of a colored line to determine whether the test is positive or negative.
Regarding home testing for anticoagulants, Nichols says that clinicians get nervous about tests that monitor medications like warfarin (Coumadin®) because of the consequences of acting on a wrong result. If the number is erroneously low, inadequate treatment could allow blood to clot. If the number is erroneously high, treatment could cause bruising or internal bleeding. For this reason, at some institutions, patients learn to perform the test, which is then verified by a clinician to ensure that the patients can competently perform the test on their own at home.
Protection for Consumers
Many manufacturers are promoting home tests on the Internet. This could be risky, unless you get savvy about which tests and sites are legitimate and which are bogus. Consumers need to watch out for unapproved home test kits that may be advertised on the Web or in magazines.
The FDA, which regulates the home testing market, holds manufacturers of home tests to a rigorous pre-market approval process. For instance, manufacturers that want their tests approved for home use must demonstrate that consumers can get results comparable to those obtained in a professional laboratory.
In addition, manufacturers must pass an intensive review of proposed labeling. A major issue in the review is whether the instructions clearly communicate information to a consumer and in a way that leads to actions that promote personal or public health and minimize illness.
What to Expect: The Future of Home Testing
Over the past few decades, healthcare has become more decentralized. Mark Hughes, a vice president and spokesman for Enterprise Analysis Corporation in Stamford, CT, says this shift means that the home testing market—which has grown tremendously in worldwide sales—will continue to grow. In fact, sales of home health screening tests are expected to grow by more than 31% between 2012 and 2017, reaching $24.2 billion worldwide, according to BCC Research.
“Technology will make testing formats easier to perform and more accurate,” Hughes says. “The markets for diagnosis and monitoring will expand; we could also see an increase in tests for screening chronic diseases.”
And first-generation tests, like prothrombin time (used to monitor anticoagulants) will lead to improved second- and third-generation devices.
“One of the biggest benefits [to home medical devices that monitor disease conditions] is connectivity,” Nichols says. “They’re not completely wireless yet, but most can store data and show individual health trends.”
In the future, your healthcare practitioner may be able to plug these devices into a computer and analyze your results. Or you may be able to use devices that sync with your own computer or smartphone, prompting them to issue regular reminders to take a reading. Researchers have already developed applications and devices that work with smartphones to take blood pressure or electrocardiogram readings. With FDA approval, smartphones may be used for many more tests in the near future. Researchers have developed phone applications and device attachments that analyze blood, saliva or urine samples for cholesterol, HIV, tuberculosis, malaria, and other conditions. Eventually, home tests may be able to send the results directly to your healthcare provider in the same manner as a text message.
The issue then becomes consumer education. “Think about how often you have a prescription for medicine that you have to take four times a day,” Nichols says, “and how many times you forget to take it.”
“But for patients who are taught well by their clinician,” he adds, “that [home test] can be a godsend.”
Home testing offers a way for you to test for medical conditions in the privacy of your own home and to monitor chronic health conditions. If you use home tests, however, protect yourself against the possibility of bogus tests, false results, and your own lack of training by following these guidelines:
Make sure that the test you are purchasing is FDA-approved. The FDA requires manufacturers to meet stringent controls for quality, precision, and accuracy (See How Reliable is Laboratory Testing? for an explanation of these terms.). Approved home tests must also meet FDA labeling requirements.
Check the expiration date. Do not buy tests if they have expired. The chemicals in the test may have lost their effectiveness and the results may not be valid.
Follow the package directions on where and how to store the test kit. Don’t leave temperature-sensitive kits in places with extreme temperatures, such as the trunk of a car or near a radiator or heater. Some tests may be sensitive to moisture and should not be left in places with high humidity, such as a bathroom.
Note and follow any special precautions before performing the test. For example, check to see when the test is to be performed (morning, evening) or under what conditions (fasting, no physical exertion, etc.).
Perform the test EXACTLY as instructed. If you have questions or are at all unsure about how to use the test, consider talking to your healthcare provider. If you have privacy or security concerns, call the 800 Help number listed on the package insert.
Make sure you understand the meaning of the test results and what to do about them. If you do not, call the Help number provided by the manufacturer or call your healthcare provider. The FDA encourages manufacturers to provide professional counseling and referral services through an 800 number.
If you have any questions or concerns about the legitimacy of the product or about whether there have been any adverse effects associated with the device, contact the Manufacturer and User Facility Device Experience Database (MAUDE). An online search is available. You can search the FDA’s database on Medical Device Recalls that may have malfunctioned or caused death or serious injury.
Consult the following agencies for additional consumer information. These are general links that will require additional searching for relevant information:
Source Used in Current Review
Gnoth, C. and Johnson, S. (2014 July). Strips of Hope: Accuracy of Home Pregnancy Tests and New Developments. Geburtshilfe Frauenheilkd. Available online at http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4119102/. Accessed on 12/15/2015.
Hynes, V. (2013 Feb 19). The Trend Toward Self Diagnosis. Canadian Medical Association Journal. Available online at http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3576458/. Accessed on 12/15/2015.
(2014 December 10, Updated). How You Can Get the Best Results With Home Use Tests. U.S. Food and Drug Administration. Available online at http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/InVitroDiagnostics/HomeUseTests/ucm125664.htm. Accessed on 12/15/2015.
(2014 June 05, Updated). U.S. Food and Drug Administration. Hepatitis C. Available online at http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/InVitroDiagnostics/HomeUseTests/ucm125785.htm. Accessed on 12/15/2015.
(2015 October 16, Reviewed). HIV/AIDS Home Tests. Centers for Disease Control and Prevention. Available online at http://www.cdc.gov/hiv/testing/hometests.html. Accessed on 12/15/2015.
Byrne, S. (2015 August 11). Do-it-yourself Health Screening Tests That Are Worth the Money. Consumer Reports. Available online at http://www.consumerreports.org/cro/news/2015/08/do-it-yourself-health-screening-tests/index.htm. Accessed on 12/15/2015.
Topol, E. J. (2015 January 09). The Future of Medicine is in Your Smartphone. Wall Street Journal. Available online at http://www.wsj.com/articles/the-future-of-medicine-is-in-your-smartphone-1420828632. Accessed on 12/15/2015.
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Sources Used in Previous Reviews
Mark Hughes and Joseph Keane, Enterprise Analysis Corporation, Stamford, CT. Interviews: 7/3/01 and 7/2/01.
James Nichols, PhD, Baystate Medical Center, Springfield, MA. Interview: 6/21/01.
Farley, Dixie. In-Home Tests Make Health Care Easier. FDA Consumer. December 1994. Available online at http://www.fda.gov/bbs/topics/CONSUMER/CON0292f.html.
Frost and Sullivan; cited in “Home Tests” by Deborah Shelton for amednews.com. Available online at http://www.ama-assn.org/sci-pubs/amnews/pick_99/feat0405.htm.
International Workshop on the Standardization of Whole Blood Coagulation Devices (transcript). August 13, 1999. Sponsored by the Department of Health and Human Services, the FDA, the Center for Devices and Radiological Health (CDRH), and the College of American Pathologists (CAP). Report available on the FDA website as a PDF at http://www.fda.gov/cdrh/ode/wbcw-transcript.pdf or from Miller Reporting Company, Inc., 507 C St. NE, Washington, DC 20002.
Kurtzweil, P. Internet Sales of Bogus HIV Test Kits Result in First-of-Kind Wire Fraud Conviction. FDA Consumer 1999. Available online at http://www.fda.gov/fdac/departs/1999/499_irs.html.
Weissman DW. Over-the-Counter Test Sales Are a Growing Market. Laboratory Industry Report 2001;X(2):9. Additional information available at: Diagnostic Testing and Technology Report, Feb 2001. Enterprise Analysis Corporation.
Kibak P. The Outlook on Home, Direct Access Testing: Are Consumers Ready to Manage Their Health? Clinical Laboratory News. March 2008: Volume 34, Number 3. Available online at http://www.aacc.org/publications/cln/2008/mar/Pages/cover2_0308.aspx. Accessed April 2008
Morago, Greg. Over-the-counter DNA home-test kits have hit the market. Lifebeat.com. The Providence Journal. Available online at http://www.projo.com/lifebeat/content/home_dna_test_12-26-07_DO8CMJB_v4.10ab70e.html. Accessed June 2011.
Emery J. Stephans, MS, Gerard Conti, MS, Michelle Keane, MBA, and Susan Farber, MBA. Does the Economic Downturn Impact Point of Care? Point of Care. Volume 8, Number 4, December 2009.