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At-home testing

FDA-Authorized At-Home STI Tests: What Each Type Can and Can't Do

"At-home STI test" can mean three very different things. Here is how each one works, which specific tests the FDA has authorized, and when a clinic visit is still the smarter move.

8 min read Updated November 2026 STD Testing Quick Editorial Team
In this guide
  1. Three kinds of "at-home" testing
  2. At-home STI tests the FDA has authorized
  3. What at-home testing does well
  4. When a clinic visit is the better choice
  5. Side-by-side: home, lab order and clinic
  6. How to choose the right option for you
  7. Frequently asked questions

Key takeaways

  • "At-home" covers three formats: true self-tests that show a result at home, home-collection kits you mail to a lab, and online orders where you give a sample at a lab.
  • The FDA has authorized or approved a small number of specific home products, including an HIV self-test, a chlamydia/gonorrhea home-collection kit, a chlamydia/gonorrhea/trichomoniasis self-test, and a syphilis antibody self-test.
  • Every FDA announcement we reviewed says positive results need medical follow-up, and some home results need a lab test to confirm them.
  • Home testing is a good fit for routine screening without symptoms. Symptoms, pregnancy, a recent possible HIV exposure, or a partner's diagnosis are reasons to see a clinician.
  • Whatever format you choose, timing matters: testing too soon after an exposure can miss an infection.

Walk into a pharmacy or search online and you will find plenty of products promising "STI testing at home." Some of them really do give you a result on your kitchen table. Others are collection kits: you swab or fill a tube at home, mail it back, and a lab runs the test. And some services just let you order the test online, then send you to a nearby lab to give your sample. All three can be useful. They just aren't the same thing, and they differ in what they can detect, how fast you get an answer, and what happens if a result is positive. This guide sorts it out, using the FDA's own announcements to show which specific home products it has authorized. If you want product-by-product comparisons, our at-home STD test comparison covers that. This article explains the categories so you can judge any kit you come across.

Three kinds of "at-home" testing

Before comparing products, it helps to know which format you are looking at. The packaging doesn't always make it obvious.

Format 1

Self-test

You collect the sample and the test itself shows the result at home, sometimes through a phone app. Nothing gets mailed.

Format 2

Home-collection kit

You collect urine, a swab or a finger-prick blood sample at home and mail it to a laboratory. Results come back online.

Format 3

Online lab order

You choose tests online, then visit a lab location for a quick sample collection. No exam, but the testing is done in a lab.

A clinic visit is the fourth option and the traditional one. A clinician can examine you, choose tests based on your symptoms and sexual history, swab specific body sites, and often treat you the same day.

The format matters because a self-test is limited to what fits in a small device, while a lab can run a much wider menu. For a deeper look at the last two formats, see same-day lab testing vs mail-in home kits.

At-home STI tests the FDA has authorized

The FDA reviews many diagnostic tests before they can be sold, and it has made public announcements about several home-use STI products. The table below lists the ones we confirmed directly on fda.gov or cdc.gov. It is not a complete registry, and new products may have been authorized since these announcements.

ProductWhat it checks forFormatKey limits the FDA or CDC notes
OraQuick In-Home HIV TestHIV antibodiesSelf-test, result at homeAntibody tests can miss a recent infection. Positive results need a follow-up test to confirm. CDC says self-tests are usually not recommended for people on PrEP.
Simple 2 Test (LetsGetChecked), authorized November 2023Chlamydia and gonorrheaHome collection (vaginal swab or urine), mailed to a labFor adults 18 and older. A health care provider follows up on positive or invalid results. False positives and false negatives are possible.
Visby Medical Women's Sexual Health Test, authorized March 2025Chlamydia, gonorrhea and trichomoniasisSelf-test with a vaginal swab; results in about 30 minutes in an appAuthorized for females with or without symptoms. People with positive results should seek medical care. People with symptoms or a recent exposure who test negative should still contact a provider.
First To Know Syphilis Test, authorized August 2024Antibodies to the bacterium that causes syphilisSelf-test with a blood sample; results in about 15 minutesA positive result needs follow-up lab testing. It can be positive in someone who was treated in the past, so it can't tell an old infection from a current one.
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Good to know

When the FDA authorized Simple 2 in 2023, it described it as the first test with at-home sample collection for an STI other than HIV. Many other companies sell home-collection kits that are processed by labs. If authorization matters to you, ask the company whether its specific kit is FDA-authorized and which laboratory runs the test.

One pattern shows up in every announcement: the main risks are false positives and false negatives. A false negative can delay treatment and lead to unknowingly passing an infection on. A false positive can lead to unnecessary treatment and worry. That's not a reason to avoid home tests. It's a reason to treat a home result as one step, not the final word. Our guide to why STI tests can be wrong explains the common causes.

What at-home testing does well

Home and online options have made testing easier for many people, especially anyone who has put it off. They tend to work best when:

Sample quality is the biggest thing you control. Read the instructions before you start, collect at the time of day the kit recommends, and ship it promptly. Our list of at-home kit collection mistakes shows what most often goes wrong.

When a clinic visit is the better choice

There are situations where a home test alone isn't enough, or where time matters more than convenience.

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Possible HIV exposure in the last 3 days?

Don't wait to test. CDC says PEP (post-exposure prophylaxis) must be started within 72 hours of a possible HIV exposure, and sooner is better. Contact a health care provider, urgent care or an emergency room now.

Side-by-side: home, lab order and clinic

Details vary by company and clinic, so treat this as a general map rather than a promise about any one service.

Self-testHome-collection kitOnline lab orderClinic visit
Where the sample is collectedHomeHomeLab locationClinic
Who runs the testThe deviceA laboratoryA laboratoryClinic or lab
Range of testsNarrowModerate to broadBroadBroadest, guided by an exam
Speed of resultMinutesMailing time plus lab timeLab timeSome rapid results, most from a lab
Exam for symptomsNoNoNoYes
Treatment if positiveArrange separatelySome services offer a consultSome services offer a consultOften the same visit

Some online services let you pick tests and then visit a partner lab, which gets you lab-grade testing without a clinic appointment. If that format suits you, STDcheck is one service the site has compared that works this way.

Prefer a lab test without a clinic visit?Order online, then give your sample at a nearby lab location. Check which tests are included before you buy.
Visit STDcheck →
Looking for an HIV self-test?The OraQuick In-Home HIV Test is FDA-approved and sold at retail. Remember it's an antibody test, so timing matters.
Search on Amazon →

How to choose the right option for you

  1. Check for urgent situations firstPossible HIV exposure in the last 72 hours, sexual assault, pregnancy or noticeable symptoms all point to in-person care.
  2. Work out which infections to test forScreening recommendations depend on age, anatomy, partners and the kind of sex you have. Our CDC screening recommendations by group lays it out.
  3. Think about body sitesOral or anal sex can mean throat or rectal infections that a urine test won't catch. See chlamydia and gonorrhea sample types.
  4. Check the timingTesting too soon after an exposure can miss an infection. Our window periods guide covers this, and a clinician can advise on your situation.
  5. Pick the format and check the follow-upBefore you buy, find out what happens if a result is positive: Is there a clinician consult? Will they help with treatment and partner notification?
  6. Plan for costInsurance often covers screening when it's done through an in-network provider. See does insurance cover STI testing? and free testing options.

When results come back, our guide to reading STI test results explains terms like "reactive," "detected" and "titer."

Frequently asked questions

Are at-home STI tests as accurate as clinic tests?

It depends on the product and the format. Home-collection kits are tested in laboratories, and some self-tests have been reviewed by the FDA. The FDA notes that false positives and false negatives are the main risks of these products, and a sample collected incorrectly or too soon after exposure can give a misleading result. Treat a home result as a starting point and follow up with a clinician when a result is positive or you have symptoms.

Which at-home STI tests are FDA-authorized?

Announcements we confirmed on fda.gov and cdc.gov include the OraQuick In-Home HIV Test, the Simple 2 home-collection test for chlamydia and gonorrhea, the Visby Medical Women's Sexual Health Test for chlamydia, gonorrhea and trichomoniasis, and the First To Know Syphilis Test. Others may have been authorized since, so check a specific product's claims with the company.

Do I need a prescription for an at-home STI test?

The FDA announcements for Simple 2, the Visby test and the First To Know syphilis test all describe them as available without a prescription. Other services may include a clinician review as part of the order.

What should I do if my at-home test is positive?

Contact a clinician, a sexual health clinic or your health department. Some positive home results, such as a syphilis antibody self-test, need a lab test to confirm them. Most bacterial STIs are treatable, and a clinician can also help with partner notification and retesting.

Can a home test tell me if I was just exposed?

Usually not right away. Every test has a window period after exposure when an infection may not be detectable yet. If the possible exposure was to HIV and happened within the last 72 hours, seek care right away to ask about PEP instead of waiting to test.

Compare your testing options

See how home kits and lab-based services stack up, including what each one tests for and how results are delivered.

Compare at-home tests →

Sources

  1. FDA Grants Marketing Authorization of First Test for Chlamydia and Gonorrhea with At-Home Sample Collection — U.S. Food and Drug Administration
  2. FDA Grants Marketing Authorization of First Home Test for Chlamydia, Gonorrhea and Trichomoniasis — U.S. Food and Drug Administration
  3. FDA Marketing Authorization Enables Increased Access to First Step of Syphilis Diagnosis — U.S. Food and Drug Administration
  4. HIV Self-Testing — Centers for Disease Control and Prevention
  5. Getting Tested for HIV — Centers for Disease Control and Prevention
  6. Post-Exposure Prophylaxis (PEP) — Centers for Disease Control and Prevention

This article is for general information only and is not medical advice, diagnosis or treatment. Testing needs differ from person to person, so talk with a clinician, local health department or sexual health clinic about your situation. If you think you were exposed to HIV in the last 72 hours, seek care right away to ask about PEP. Guidance referenced here was checked against official sources in October 2026 and can change. Some links on this site are affiliate links, which means we may earn a commission if you buy through them, at no extra cost to you.