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In March 2025 the Food and Drug Administration (FDA) authorized an over-the-counter home test for three common and curable sexually transmitted infections (STIs): chlamydia, gonorrhea and trichomoniasis.[1]
The test, called the Visby Medical Women’s Sexual Health Test, is authorized only for female users with or without symptoms of an STI. It is the first FDA-approved test for chlamydia, gonorrhea and trichomoniasis that can be performed entirely at home. It was reviewed under a pathway...
In March 2025 the Food and Drug Administration (FDA) authorized an over-the-counter home test for three common and curable sexually transmitted infections (STIs): chlamydia, gonorrhea and trichomoniasis.[1]
The test, called the Visby Medical Women’s Sexual Health Test, is authorized only for female users with or without symptoms of an STI. It is the first FDA-approved test for chlamydia, gonorrhea and trichomoniasis that can be performed entirely at home. It was reviewed under a pathway for new devices that are considered low or moderate risk.[2]
The FDA has previously authorized an at-home test for syphilis, as well as a test for chlamydia and gonorrhea with at-home sample collection but processing in a laboratory.[3]
For chlamydia, the new test correctly identifies 98.8% of negative cases and 97.2% of positive cases; for gonorrhea, 99.1% and 100% of cases, respectively; and for trichomoniasis, 98.5% and 97.8% of cases, respectively, according to the FDA.[4] Users who receive a positive result should see a clinician for confirmation and treatment. Those who receive a negative result but still have symptoms or concerns should also see a clinician for further testing.
While at-home STI tests do offer convenience and privacy that may be appealing, there are some drawbacks you should consider before using them. Although the tests are very accurate, there is still a small chance of receiving a false positive or false negative result. A false positive result could lead to unnecessary treatment, and a false negative result could cause an infection to go untreated. Additionally, patients who receive a positive result will need to follow up with a clinician to receive treatment; this extra step may be a barrier to some patients.
If you are sexually active, the best ways to prevent contracting or spreading STIs are to use male or female condoms and to get tested regularly, whether at the doctor’s office or at home. Keep in mind that the at-home tests cannot detect all STIs.
References
[1] Food and Drug Administration. FDA news release. FDA grants marketing authorization of first home test for chlamydia, gonorrhea and trichomoniasis. March 28, 2025. https://www.fda.gov/news-events/press-announcements/fda-grants-marketing-authorization-first-home-test-chlamydia-gonorrhea-and-trichomoniasis. Accessed July 3, 2025.
[2] Food and Drug Administration. De Novo classification request. Updated October 4, 2022. https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/de-novo-classification-request. Accessed July 3, 2025.
[3] Food and Drug Administration. FDA news release. FDA grants marketing authorization of first home test for chlamydia, gonorrhea and trichomoniasis. March 28, 2025. https://www.fda.gov/news-events/press-announcements/fda-grants-marketing-authorization-first-home-test-chlamydia-gonorrhea-and-trichomoniasis. Accessed July 3, 2025.
[4] Food and Drug Administration. FDA news release. FDA grants marketing authorization of first home test for chlamydia, gonorrhea and trichomoniasis. March 28, 2025. https://www.fda.gov/news-events/press-announcements/fda-grants-marketing-authorization-first-home-test-chlamydia-gonorrhea-and-trichomoniasis. Accessed July 3, 2025.
