At-Home Tests: What You Need to Know
At-home testing is a growing part of health care that, like telemedicine, has captured more and more interest during the COVID-19 pandemic. Direct-to-consumer (DTC) at-home tests now include a diverse range of test types offered by numerous companies, providing customers and patients more options than ever before.
However, not all at-home tests are created equal. It’s normal for people who are considering at-home testing to have questions about how testing works, whether it’s safe and accurate, and how it compares to traditional laboratory testing.
This guide reviews essential information about at-home testing that can shed light on these important questions and help every individual make an informed choice about whether a specific at-home test is right for them.
Types of At-Home Tests
At-home tests can be classified into three main types:
- Self-tests: A self-test allows the entire process to be conducted at home. A sample is collected at home, and results are provided on-site. The test kit includes information about how to interpret the result. In most cases, self-tests provide rapid results in under an hour.
- Self-collection tests: Self-collection involves taking a sample at-home and then sending it to a laboratory where it can be analyzed. Results are usually provided electronically once the lab has finished its analysis.
- Tests ordered from home: For these tests, sample collection and analysis are done in a laboratory, but a specially designed website streamlines scheduling and paying for the test. By handling all the pretest paperwork and logistics at home, this option can simplify the process and make testing more convenient.
Self-tests and self-collection tests are typically available as at-home kits that are designed to be self-administered, but in some cases, assistance may be provided by another person or a home health professional. At-home test kits for children generally require testing to be conducted by an adult.
For people who are homebound or have specific medical needs, special at-home testing options may be available through home nursing or home health care services. Patients in need of these services should talk with their doctor or a medical social worker.
Prescription and over-the-counter at-home tests
Some at-home tests require a prescription from a licensed health professional in your state. In contrast, over-the-counter tests can be purchased either online or in a physical store without a doctor’s order.
Many providers of prescription at-home tests provide services to get the prescription required to obtain a test kit. This usually involves submitting a questionnaire or other health information so that a physician can verify that you meet basic requirements for receiving the test.
For both prescription and over-the-counter at-home tests, it’s best to discuss testing with a doctor who is familiar with your health history. Your doctor can review the benefits and risks of testing, order a test if appropriate, and once you have results, explain their significance in your specific situation. Note that if your doctor did not prescribe the at-home test, they may decline to interpret the results and instead may recommend repeating the test using traditional laboratory methods.
Uses of At-Home Tests
At-home tests can have a variety of uses. The most common uses of at-home tests include:
- Screening is looking for signs of a health problem before any symptoms have occurred. For example, at-home testing can look for sexually transmitted diseases (STDs) that may not cause symptoms, which can help avoid unknowingly spreading it to others.
- Diagnosis is the identifying the cause of a health problem after symptoms have started. For example, at-home tests may detect infectious diseases like COVID-19. It is important to note, though, that only a doctor can formally diagnose a health condition, and they will need to conduct additional tests to confirm the results of at-home testing.
- Monitoring is tracking how a person’s health changes over time or in response to treatment. At-home kits that allow people with diabetes to measure their blood sugar are an example of monitoring.
- Disease risk assessment: In some situations, testing can reveal when a person has a higher risk of developing a disease. For instance, some genetic tests can look for DNA mutations that are associated with certain types of cancer, such as BRCA gene mutations and an increased risk of breast and ovarian cancer.
- Wellness optimization: Some tests don’t look for a specific problem; instead, they are designed to help you understand one or more aspects of your physical, mental, or emotional wellness. These tests may measure hormones, nutrient levels, or other substances to offer more information about your body. Many of these tests have not been validated to improve health, so it is important to scrutinize these test kits and use them with caution.
- Ancestry research: Genetic testing can analyze your DNA to reveal information about your family history. This testing may shed light on your ancestry or even uncover unknown family relationships.
Benefits and Downsides of At-Home Tests
Interest in at-home tests is growing, but it’s important to consider their pros and cons. While benefits and downsides can depend on the specific test, there are some general advantages and disadvantages to at-home testing.
Some of the key benefits include:
- Convenience: At-home tests allow you to get tested on your own schedule and without having to schedule an appointment, go to a medical office, or even leave the comfort of your home.
- Expanded access to testing: The ability to order and take tests from home simplifies the testing process and makes many tests more available to the public.
- Patient knowledge and empowerment: Patients are becoming more informed and active in their health care, and at-home testing can be a source of new information about their health and wellness.
- Transparent cost: In most cases, at-home tests ordered online have a set price that is clearly displayed, and it is rare to encounter hidden fees.
Potential downsides to at-home testing include:
- Lack of medical guidance: For many at-home tests, results are provided with little or no consultation with a doctor. Interpreting a test result can be complicated and requires consideration of your overall health, but at-home tests frequently do not provide this important context.
- Unvalidated tests: Not all at-home tests are validated to deliver accurate measurements, and some tests may provide information that is not proven to be relevant for health decision-making.
- Inconsistent test quality: As with many consumer products, at-home test kits can have different levels of quality, and it is often difficult to determine which tests are reliable.
- Out-of-pocket cost: A significant number of at-home tests are not covered by health insurance, which means that all costs must be paid by the patient.
- Potential test error: Reliable test results depend on proper sample collection, and there may be a higher risk of error in sample collection compared to samples taken at a medical office by a trained nurse or technician.
Finding At-Home Tests
At-home tests have become widely available through a variety of outlets. Many pharmacies and drug stores sell over-the-counter tests in their physical stores and on their websites.
Major online retailers as well as online companies specializing in testing have dramatically expanded options for purchasing at-home tests.
For people who need in-home health care, services for mobile sample collection, such as mobile phlebotomy, may be arranged through a doctor or through third-party companies offering home health care with trained health professionals.
Costs of At-Home Tests
The cost of at-home testing can vary significantly based on the type of test, whether laboratory analysis is required, and whether coverage is provided by health insurance.
In most cases, at-home testing is not covered by insurance. Tests that are purchased at a pharmacy or online usually must be paid for entirely by the patient or customer. Many companies that offer at-home tests accept payment with funds from a health savings account (HSA) or flexible spending account (FSA).
Some insurance providers may cover at-home testing that is prescribed by a doctor in their network. Certain costs may also be covered for people with a demonstrated medical need for home health care.
Taking At-Home Tests
Types of sample collection
The sample for an at-home test is tailored to what the test is designed to measure. The most common specimens used for at-home tests are blood, urine, saliva, stool, or a respiratory swab.
An at-home test kit will indicate the kind of sample required. The kit will also include materials and detailed instructions for collecting your sample. Following these instructions carefully and using only materials in the kit is critical both for taking self-tests and for correctly storing a sample to send to a laboratory.
Properly taking an at-home test
If you are planning to take an at-home test, these practical tips can help you avoid misleading or invalid results:
- Check the expiration date: Do not buy or use tests if they have expired because the materials or chemicals in the test may have lost their effectiveness.
- Store the test correctly: Follow the package directions on where and how to store the test kit. Many tests are sensitive to temperature or humidity and must be stored properly.
- Read the instructions in full before taking the test: Don’t try to take the test on the fly. Instead, make sure to read the instructions first so that you understand each step of the process and have everything you need at-hand. Many testing companies now offer online videos or tutorials to guide you through taking the test correctly.
- Account for special procedures: Look carefully to see if the test has to be taken at a certain time of day or under special physical conditions like fasting.
- Follow instructions to a T: 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.
Results From At-Home Tests
Getting results from at-home tests
If you take an at-home self-test, results are usually available in less than 60 minutes. Many rapid self-tests provide results almost immediately. The test kit itself will include a mechanism for seeing and interpreting your results.
For self-collection tests or laboratory tests that you order from home, you will generally get results through an online health portal. Because these tests require laboratory analysis and may need to be shipped to the lab, it often takes a few business days before results are available.
Understanding results from at-home tests
At-home tests can provide useful information, but it is important to understand the results in the context of what the test measures, its accuracy, and how it applies to your specific situation. Because accounting for these factors can be complex, it is advisable to ask your doctor to review the results of any at-home test with you. Note that some doctors may refrain from discussing at-home testing results and prefer to repeat the test in a medical setting to confirm the results.
Some self-tests provide immediate results with instructions for interpreting the test. If you have any doubts about how to use or interpret the test, you should contact the test manufacturer or your doctor. For many conditions, at-home self-tests require follow-up testing before any diagnosis can be made. For example, the results from an at-home HIV test generally require confirmation with a laboratory blood test.
For tests that are analyzed by a laboratory, you will receive a formal test report. This report shows the laboratory reference range and your test levels. The report may also include information about what your results may mean. Some testing companies offer services to consult with a physician about the outcome of your test.
Remember that tests can be used for different purposes. Tests that are designed to guide medical decision-making should be noted in your medical record. These tests are usually prescribed by a doctor and performed by a health professional.
Other types of tests provide information about wellness but are not intended to directly affect medical decision-making. It is important to recognize the limitations of these tests and to talk with a doctor prior to making any changes to your diet, lifestyle, or other aspects of your health.
Accuracy of at-home test results
The quality and accuracy of at-home tests varies considerably and is related to factors such as the type of test sample, the testing method, and the quality of the test kit. For this reason, there is no general rule about the accuracy of at-home test results.
Some at-home self-tests are approved by the FDA, which indicates that the test has been documented to deliver results that are comparable to similar laboratory tests or other rapid, point-of-care tests provided in hospitals and doctors’ offices.
Many self-collection tests are analyzed in laboratories that have met regulatory standards for quality assurance. Examples of these standards include Clinical Laboratory Improvement Amendments (CLIA) certification or accreditation from the College of American Pathologists (CAP).
While many at-home test kits can provide useful information, they are typically not as accurate or dependable as laboratory tests ordered by a physician and performed in a medical setting. Doctors, nurses, technicians, and laboratory professionals are trained to follow specific procedures in sample collection, specimen handling, and test analysis. These procedures and best practices improve the accuracy and reliability of laboratory testing but are difficult to replicate in at-home tests.
Talking to Your Doctor About At-Home Tests
Your doctor plays a critical role in your overall health care, so you can get the most out of at-home testing by talking with your doctor before and after taking any specific test.
Some questions that you can bring up before testing include:
- Is there any risk or downside to this test?
- Does this kind of test provide meaningful results?
- Should any test results be recorded in my medical record?
- Do you advise any other tests or follow-up care?
If you’ve already taken an at-home test, these questions may be helpful to bring up with your doctor:
- Is the test result that I received reliable?
- Should I make any health changes or have any treatment based on my test result?
- Do you recommend any follow-up testing?
Frequently Asked Questions About At-Home Tests
Are at-home tests safe?
Every at-home test has specific benefits and risks. While many tests are safe for most healthy adults, some tests can pose health risks.
The risks of any at-home test can increase because of poor product quality or if test kits are used inappropriately or without following test instructions.
To reduce risks of at-home testing, check the packaging closely for any precautions or restrictions. Only use products designed for use in the U.S. market, and never mix and match materials, including chemicals or test strips, from different test kits. When possible, opt for self-tests that are FDA-approved.
Even when the test itself does not pose a risk, testing can be detrimental if it improperly influences health decisions. For that reason, you should never make any decisions about your health, lifestyle, or treatment without first speaking with a doctor.
How is my privacy protected with at-home tests?
For self-collection tests, a laboratory will interpret your test and provide results online. Most test providers use a password-protected health portal, but it is advisable to look up the details related to how your personal information is used and protected.
Will at-home tests save me a trip to the doctor?
Although at-home testing is convenient, it is not a substitute for seeing your doctor if you have symptoms or other health concerns. A doctor can help assess your current health and determine the type of testing that is most appropriate in your situation.
For some types of at-home tests, a negative result may seem to reduce the need to go to the doctor’s office. However, it’s still best to check with your doctor because at-home test results often need to be confirmed with a laboratory test.
Ayala-Lopez N, Nichols JH. 93-1198.Benefits and Risks of Direct-to-Consumer Testing. Arch Pathol Lab Med. 2020;144(10):11 doi:10.5858/arpa.2020-0078-RA
Centers for Disease Control and Prevention. COVID-19: Self-testing. Updated August 2, 2021. Accessed August 19, 2021. https://www.cdc.gov/coronavirus/2019-ncov/testing/self-testing.html
Court E. Quest sees direct-to-consumer testing taking off post-pandemic. Bloomberg. Published March 11, 2021. Accessed August 22, 2021. https://www.bloomberg.com/news/articles/2021-03-11/quest-sees-direct-to-consumer-testing-taking-off-post-pandemic
Ibitoye M, Frasca T, Giguere R, Carballo-Diéguez A. Home testing past, present and future: lessons learned and implications for HIV home tests. AIDS Behav. 2014;18(5):933-949. doi:10.1007/s10461-013-0668-9
Procop GW, Kadkhoda K, Rhoads DD, Gordon SG, Reddy AJ. Home testing for COVID-19: Benefits and limitations [published online ahead of print, 2021 Mar 1]. Cleve Clin J Med. 2021;10.3949/ccjm.88a.ccc071. doi:10.3949/ccjm.88a.ccc071
Tidy EJ, Shine B, Oke J, Hayward G. Home self-testing kits: helpful or harmful?. Br J Gen Pract. 2018;68(673):360-361. doi:10.3399/bjgp18X698021
US Food and Drug Administration. Direct-to-consumer tests. Updated December 20, 2019. Accessed August 19, 2021. https://www.fda.gov/medical-devices/in-vitro-diagnostics/direct-consumer-tests
US Food and Drug Administration. FDA executive summary: Over-the-counter diagnostic tests for the detection of pathogens causing infectious diseases. Published August 16, 2016. Accessed August 19, 2021. https://www.fda.gov/media/99873/download
US Food and Drug Administration. Home use tests. Updated April 4, 2019. Accessed August 19, 2021. https://www.fda.gov/medical-devices/in-vitro-diagnostics/home-use-tests
US Food and Drug Administration. How you can get the best results with home use tests. Updated December 28, 2017. Accessed August 19, 2021. https://www.fda.gov/medical-devices/home-use-tests/how-you-can-get-best-results-home-use-tests
US Food and Drug Administration. Laboratory developed tests. Updated September 27, 2018. Accessed August 19, 2021. https://www.fda.gov/medical-devices/in-vitro-diagnostics/laboratory-developed-tests