At-home lab test kits let you collect a sample at home and mail it to a lab. Before you buy one, check four things: the lab's certification, how the sample is taken, how your data is handled, and who explains the result.
Check that the lab is CLIA certified
In the United States, the Centers for Medicare & Medicaid Services (CMS) regulates almost all lab testing on humans through the Clinical Laboratory Improvement Amendments, known as CLIA. Congress passed the law in 1988. Its goal is to keep lab testing quality up.
Ask the kit company for the name of the lab that runs your sample. Then ask for that lab's CLIA number. A real lab can give it to you. If the company will not name the lab, treat that as a warning sign.
CLIA is a federal program, but state agencies keep the certificate records. So a state agency can help you confirm that a lab holds a certificate. Some states also have their own lab licensing laws.
Sources: CMS, Clinical Laboratory Improvement Amendments (CLIA) page, cms.gov.
Look for extra accreditation
CLIA is the floor. Some labs choose more. The College of American Pathologists (CAP) runs a Laboratory Accreditation Program. CMS has given that program deeming authority, which means a CAP inspection can stand in for a CMS inspection.
CAP also keeps a public search tool for accredited laboratories. If a kit maker says its lab is CAP accredited, you can look it up instead of taking its word.
No badge makes a test perfect. But a lab that can show its CLIA certificate and a CAP listing has given you something you can check.
Sources: College of American Pathologists, Laboratory Accreditation Program and Accreditation pages, cap.org.
Understand what the FDA does and does not review
The Food and Drug Administration (FDA) calls these products direct-to-consumer tests. They are tests sold to you without a health care provider involved. You usually collect a specimen, such as saliva or urine, and send it to the company.
The FDA does not review every one. In general, tests for non-medical, general wellness or low risk purposes are not reviewed before sale. Tests for moderate to high risk medical purposes are generally reviewed. The FDA keeps a list of direct-to-consumer tests that have received marketing authorization, so you can check whether a kit is on it.
The FDA also says these tests have varying levels of evidence behind their claims. Read the claims on the box with that in mind. A big promise with no data behind it is a reason to skip the kit.
Sources: FDA, Direct-to-Consumer Tests page, fda.gov.
Check the sample method
Ask how you will collect the sample. Common choices are a finger prick, a saliva tube or a urine cup. Each method suits some tests and not others. The instructions should be clear enough that a person with no training can follow them.
The FDA says it looks at the language a company uses to tell users how to collect a sample. That is a good test for you too. Read the instructions before you buy, if the company posts them. Vague steps lead to bad samples, and a bad sample can give a bad result.
Also ask about shipping. Find out how long the sample can travel, and what the company does if it arrives damaged or too small.
Sources: FDA, Direct-to-Consumer Tests page, fda.gov.
Read the privacy terms and ask who explains results
A sample and a result are personal data. Before you pay, read the privacy policy. Look for answers to three plain questions. Does the company sell or share your data? Can you ask it to delete your data and your leftover sample? What happens to your data if the company is sold?
Then ask who explains the result. The FDA suggests that consumers think about talking over results with a genetic counselor or a qualified health care provider. That is sound advice for any kit. A good company tells you up front how you can reach a clinician, and whether that costs extra.
A result number alone is not an answer. It needs context, such as the normal range the lab used and what else is going on with you. If something in the result worries you, speak with a health care professional rather than relying on the kit alone.
The FDA also asks users to report problems with direct-to-consumer tests through MedWatch, its voluntary reporting program. Keep that in mind if a kit gives you a result that seems wrong.
Sources: FDA, Direct-to-Consumer Tests page, fda.gov.
A quick checklist
- Can the company name its lab and give a CLIA number?
- Is the lab also listed as CAP accredited?
- Is the kit on the FDA's list of authorized direct-to-consumer tests, or does it make only wellness claims?
- Are the sample steps clear and the shipping rules stated?
- Does the privacy policy say who sees, keeps and deletes your data?
- Can you reach a clinician to explain the result?
If the answer to several of these is no, pick another kit. Spending a few minutes on these checks costs far less than acting on a poor result.
Sources: CMS, CLIA page; College of American Pathologists, accreditation pages; FDA, Direct-to-Consumer Tests page.