Sexually transmitted infections (STIs), particularly chlamydia and gonorrhea, continue to be major public health concerns in the US. More than 1.6 million chlamydia cases, 600,000 gonorrhea cases, and 2.6 million Trichomonas cases were reported to the CDC in 2023. Syphilis cases increased 80% in the US between 2018 and 2022.
If left untreated, these diseases can lead to long-term sequelae such as pelvic inflammatory disease, ectopic pregnancy, tubal infertility, and increased risk of acquiring HIV. Even more worrisome, Neisseria gonorrhea has developed resistance to all previously used antibiotics. Therefore, detection and treatment are essential countermeasures to decrease infection rates and prevent resistance to newer antibiotics.
Many public health experts believe at-home testing is a promising way to curb the spread of sexually transmitted diseases and facilitate early treatment.
On November 15, 2023, the FDA granted marketing authorization of a diagnostic test for chlamydia and gonorrhea with at-home sample collection (the Simple 2 Test).
Then, it granted marketing authorization to NOWDiagnostics for its First to Know Syphilis Test. This was the first at-home test to detect Treponema pallidum antibodies in human blood.
On March 28, 2025, FDA granted marketing authorization of a diagnostic test for chlamydia, gonorrhea, and trichomoniasis that can be performed entirely at home (the Visby Medical Women’s Sexual Health Test). Both tests are direct-to consumer tests that can be purchased without a prescription.
With the Simple 2 Test, a person can order the test online. A male collects a urine sample and a vaginal swab at home. The samples are mailed to a designated laboratory. Testing is performed on a Hologic Panther instrument using Hologic’s Aptima Combo 2 Assay, which utilizes nucleic acid amplification.
Results are provided in 2 to 5 days with a follow-up from a clinician for positive or invalid test results. The ordering person can request a virtual consultation for an additional fee. If the chlamydia test result is positive, oral treatment can be sent to the home.
A positive gonorrhea test result requires a health care visit elsewhere, for an intramuscular injection of ceftriaxone, which is recommended treatment for uncomplicated cases.
Simple 2 is authorized for ages 18 years or older. The LetsGetChecked website offers the test for $99 and a virtual consultation for $39. Reimbursement is possible through flexible spending or health savings accounts.
The First to Know test for syphilis is performed entirely at home. It can be purchased in pharmacies for $29.95.Users prick their finger and put a drop of blood on a test strip. Results are available in 15 minutes. First to Know had a sensitivity of 93.4% and specificity of 99.5%. Those who are asymptomatic and have a negative test do not need follow-up. Those who test positive need to see a health care provider for a confirmatory test.
With the Visby Medical Women’s Sexual Health Test is intended for women with or without symptoms. A vaginal swab is collected and tested at home. The test kit includes a sample collection kit and a powered testing device that communicates results to an app. Results are available within 30 minutes.
The FDA granted marketing authorization to Visby Medical based on testing that showed the device correctly identified 98.8% of negative and 97.2% of positive Chlamydia trachomatis samples, 99.1% of negative and 100% of positive Neisseria gonorrhea samples, and 98.5% of negative and 97.8% of positive Trichomonas vaginalis samples.
STI self-testing in the privacy of one’s home has several advantages over traditional diagnosis. Self-testing can reach people who distrust or avoid health care systems due to STI stigma, embarrassment, or questions about sexual behavior. Collecting a sample at home is more convenient because it eliminates the need for transportation and a clinic appointment. If positive, the correct antibiotic can be sent to the home.
The CDC recommends that all persons who receive a diagnosis of chlamydia or gonorrhea be tested for other STIs, including HIV and syphilis; the other STIs of clinical and public health interest include Mycoplasma genitalium, Trichomonas vaginalis, and bacterial vaginosis
References
Kersh EN, Mena LA. At-Home Diagnostics Solutions for Chlamydia and Gonorrhea. JAMA. Published online April 29, 2024. doi:10.1001/
Sexually transmitted infections surveillance, 2022: national overview of STIs, 2022. Centers for Disease Control and Prevention. Accessed February 16, 2024. https://www.cdc.gov/std/statistics/2022/overview.htm
FDA grants marketing authorization of first test for chlamydia and gonorrhea with at-home sample collection. US Food and Drug Administration. November 15, 2023. Accessed December 20, 2023. https://www.fda.gov/news-events/press-announcements/fda-grants-marketing-authorization-first-test-chlamydia-and-gonorrhea-home-sample-collection.
Workowski KA, Bachmann LH, Chan PA, et al. Sexually transmitted infections treatment guidelines, 2021. MMWR Recomm Rep. 2021;70(4):1-187. doi:10.15585/mmwr.rr7004a1
Wilson E, et al. Internet-accessed sexually transmitted infection (e-STI) testing and results service: a randomised, single-blind, controlled trial. PLoS Med. 2017;14(12):e1002479. STD testing, lab results & treatment from home. LetsGetChecked. Accessed December 20, 2023. https://www.letsgetchecked.com/home-std-test
Clark K, et al. Clinical development and performance of the First to Know Syphilis Self-Test for over-the-counter usage: a de novo rapid test for treponemal antibody. J Clin Microbiol. 2025 Sep 10;63(9):e0024425.
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