The Food and Drug Administration (FDA) has approved Visby Medical’s Women’s Sexual Health Test, the first diagnostic tool for chlamydia, gonorrhea, and trichomoniasis that can be bought over the counter and used at home. Designed for women, it provides results in about 30 minutes, even without symptoms.
Why Early Diagnosis Matters
According to the Centers for Disease Control and Prevention (CDC), more than 2.2 million cases of chlamydia and gonorrhea were reported in the U.S. in 2023. Trichomoniasis, the most common non-viral STI, affects about 2.6 million people annually. If untreated, these infections can cause serious health issues, including infertility.
Courtney Lias, director of the FDA’s Office of In Vitro Diagnostic Devices, highlighted the importance of this development:
"At-home tests offer privacy, which is key when it comes to sexually transmitted infections. Anxiety or fear often delays diagnosis and treatment, but with easier access to these tests, people can get diagnosed and treated sooner, helping to reduce the spread."
How the Test Works
The Visby Medical Women’s Sexual Health Test is a one-time use device. It comes with a self-collected vaginal swab and an electric analysis unit. After performing the test, results are securely sent to the Visby Medical app.
During clinical trials, the test proved highly accurate:
- 98.8% accuracy in detecting negative samples and 97.2% for positive chlamydia samples.
- 99.1% accuracy in negative samples and 100% for positive gonorrhea samples.
- 98.5% accuracy in negative samples and 97.8% for positive trichomoniasis samples.
Anyone who receives a positive result should follow up with a healthcare provider for confirmation and treatment. Even with a negative result, those experiencing symptoms or recent exposure should seek medical advice.
Limitations and Regulations
Like many diagnostic tests, there is a risk of false positives or false negatives. A false negative result could delay treatment, while a false positive could lead to unnecessary treatments or misdiagnoses.
The FDA approved the test through the De Novo pathway, a regulatory process for low-to-moderate risk devices. This recognition sets new standards for similar tests, allowing other manufacturers to obtain authorization through a simplified 510(k) process, reducing approval costs and time.
The announcement follows the approval of the first at-home syphilis test in 2023 and a chlamydia and gonorrhea test with at-home sample collection.
Risks, Transmission, and Prevention
Chlamydia, gonorrhea, and trichomoniasis are sexually transmitted infections (STIs), but transmission is not limited to sexual contact. Contaminated objects such as towels, underwear, or inadequately cleaned sex toys can facilitate transmission, especially in the case of trichomoniasis. Moist environments, such as saunas or public restrooms, could also pose a risk, though less commonly.
Understanding the Infections
What is chlamydia?
Chlamydia is a bacterial infection caused by Chlamydia trachomatis. Often showing no symptoms, it can lead to pelvic pain, abnormal discharge, and, if untreated, infertility or complications during pregnancy.
What is gonorrhea?
Caused by Neisseria gonorrhoeae, gonorrhea can affect the genitals, throat, and rectum. It may be asymptomatic, but severe cases cause pain, abnormal discharge, and long-term damage.
What is trichomoniasis?
Trichomoniasis is a parasitic infection caused by Trichomonas vaginalis, often spread through sexual contact, though it can survive briefly on moist surfaces. Symptoms include itching, burning, and foul-smelling discharge, but many people don’t know they have it.
How to Protect Yourself
Using condoms reduces the risk, but protection goes beyond that. Avoid sharing towels and underwear, sanitize sex toys properly, and get regular check-ups, especially when starting new sexual relationships. If you suspect an infection, don’t wait—early diagnosis prevents complications and protects others.
Glossary
- Chlamydia (Chlamydia trachomatis): A bacterial infection that affects the genital tract and, if left untreated, can cause fertility issues and pregnancy complications. Often asymptomatic.
- Gonorrhea (Neisseria gonorrhoeae): A bacterial infection that can affect the genitals, throat, and rectum. If untreated, it can cause severe inflammation and permanent reproductive damage.
- Trichomoniasis (Trichomonas vaginalis): A parasitic infection, often asymptomatic. It can cause itching, burning, and foul-smelling discharge. It is transmitted sexually but can also spread through contaminated objects.
- Sexually transmitted infection (STI): A disease that spreads mainly through unprotected sexual contact but, in some cases, can also be transmitted via contaminated objects or moist surfaces.
- Condom: A contraceptive method that reduces the risk of sexually transmitted infections and unintended pregnancies.
- De Novo (FDA): An approval process for new medical devices considered low to moderate risk, without existing market equivalents.
- Sex toys: Objects used for sexual pleasure, such as vibrators and dildos. If shared without proper cleaning, they can transmit infections, including chlamydia, gonorrhea, and trichomoniasis. Proper hygiene after each use is essential.
- 510(k) (FDA): An authorization pathway allowing medical devices to gain approval by demonstrating equivalence to an existing approved device.
