Home and Direct-to-Consumer Health Tests: What to Check Before Buying
A plain checklist for home and direct-to-consumer health tests: what regulators say, why results can mislead, and the questions to ask before acting on any result.
Content last updated . This page has not been medically reviewed.
Start here
This page is information only. It does not tell you to buy or order any test. Never stop or change a medicine because of a home test result without talking to your doctor. [1] Chest pain, stroke signs, severe breathing trouble or other emergencies need emergency care (911 in the United States), not a test kit.Two groups of tests
Home-use tests let you test for some conditions at home; the FDA gives pregnancy tests and glucose monitoring for diabetes as examples. [2] Direct-to-consumer (DTC) tests are marketed to people without a health care provider; you usually collect a sample, such as saliva or urine, and send it to a company. [3] Not all are genetic tests; some measure proteins, toxins in urine or bacterial flora. [3] Naturopathic and integrative practices, functional medicine clinics and online companies may offer or recommend such tests, and the people involved include practitioners with different training and legal scope; see credentials and scope of practice.A checklist before you act on a result
| Check | Why |
|---|---|
| What is it for, and what is it not for? | The FDA tells users to know what a test is for and what it is not for. [1] |
| Is it FDA-authorized or reviewed for this use? | Ask your pharmacist or the seller, as FDA suggests. [1] |
| Did I follow every instruction? | The FDA says all instructions must be followed to get an accurate result. [1] |
| Does a clinician review it with my history? | The FDA suggests discussing results with a qualified health care provider. [3] |
| Would a "negative" really rule something out? | For genetic DTC tests, the FDA says a negative result can still leave you at risk for a condition. [3] |
Kits sold with a treatment
Be cautious when a test comes with a product to fix what it "finds." The FDA says some makers of unapproved over-the-counter chelation products also promote home test kits to "diagnose" metal toxicities, and that these kits are not cleared by FDA and may give false or misleading results. [4] For details see provoked urine heavy-metal tests.Questions to ask a practitioner who recommends a test
- What decision will the result change?
- Who reads it, and will my own doctor see it?
- What does it cost, and do you also sell the treatment it points to?
- What is the plan if it is a false positive or false negative?
Over-testing has its own harms; see over-testing, false positives and incidental findings. The Biohacking section covers home lab testing and longevity clinic panels and biomarker tracking and at-home tests. For general weighing of claims, see how to evaluate a therapy claim.
Frequently asked questions
Are home tests reviewed by the FDA?
Some are. The FDA says tests for general wellness or low-risk medical purposes are generally not reviewed before they are offered. [3]
Can a home test give a wrong answer?
Yes. The FDA states that all tests can give false results. [1]
Should I change my medicine based on a home test?
No. The FDA says not to change medications or dosages based on a home-use test without talking to your doctor. [1]
Does a negative result mean I am safe?
Not necessarily. For DTC genetic tests the FDA says a negative result means you still may be at risk. [3]
How do I know if a test is regulated?
The FDA suggests asking your pharmacist or the vendor selling the test. [1]
More details: evidence, limits and cautions
The details behind this page: cautions, limits of the evidence and where sources disagree. Open any note to read it.
What regulators say
- Evidence varies. The FDA says direct-to-consumer tests have varying levels of evidence that support their claims. [3]
- Review depends on risk. Tests for general wellness or low-risk medical purposes are generally not reviewed by the FDA before they are offered, while moderate- to high-risk tests are generally reviewed. [3]
- Not regulated means not checked. If the FDA does not regulate a home-use test, the U.S. government has not determined that it is reasonably safe or effective. [1]
- Results can be wrong. The FDA states that all tests can give false results. [1]
- Use is not a replacement for care. Home-use tests are meant to help with health care and should not replace periodic doctor visits. [2]
This is United States information. Rules differ elsewhere, and the pages we read do not describe other countries.
References
- U.S. Food and Drug Administration. How You Can Get the Best Results With Home Use Tests. Content current as of 2017-12-28. Read 2026-10-22.
- U.S. Food and Drug Administration. Home Use Tests. Content current as of 2022-06-21. Read 2026-10-22.
- U.S. Food and Drug Administration. Direct-to-Consumer Tests. Read 2026-10-22.
- U.S. Food and Drug Administration. Questions and Answers on Unapproved Chelation Products. Page current as of 02/02/2016. Read 2026-10-22.