The FDA just approved a new, fully at-home test for chlamydia, gonorrhea, and trichomoniasis. The tests, which is only for women, will be available without a prescription. Users can collect their own sample and have results in less than 30 minutes.
There were more than 2.2 million cases of chlamydia and gonorrhea reported in the U.S. in 2023. In addition, there were an estimated 2.6 million cases of trichomoniasis (often called trich). If diagnosed early, these infections can be cured with antibiotics. When left untreated, however, they can cause serious health issues including infertility. These infections are often asymptomatic, which is why it’s important that people who are sexually active get tested even if they don’t have symptoms.
At-home STI testing has become more popular in recent years because it is private and convenient. STI tests can be bought online or in pharmacies and are sometimes available for free from health departments. Most of the kits on the market today let users collect their own sample but don’t give results right away. Instead, users mail the tests to a lab and get the results in a few days.
The new Visby Medical Women’s Sexual Health Test is different. It can be done entirely at home. It comes with a collection kit that allows user to swab their vagina and a powered testing device that processes the sample and sends the results to an app. Users get their results on the app.
Anyone who tests positive needs to see a health care provider either in person or via telemedicine so they can get right medication. Anyone who has symptoms should see a health care provider even if they test negative.
This test can be used by with or without symptoms. Clinical trials found that Visby Medical Women’s Sexual Health Test was accurate. It correctly identified:
Experts believe that at-home STI testing can help ensure that more people get tested by removing the barriers involved with having to see a health care provider—whether that’s finding a clinic, scheduling an appointment that doesn’t interfere with work, securing transportation, or overcoming the feelings of embarrassment that can happen when talking to a doctor in person.
A recent study found that 70% of young people say they would prefer testing for STIs at home over going to a doctor’s office or clinic. Respondents cited convenience, privacy, and comfort as reasons for preferring STI self-collection kits.
Courtney Lias, PhD, director of FDA’s Office of In Vitro Diagnostic Devices said in a statement, “Expanding access to tests for sexually transmitted infections is an important step toward earlier and increased diagnosis, which can result in increased treatment and reduced spread of infection.”
This test joins a few others that can be done entirely at home. An at-home HIV test was approved in 1996, and the FDA approved a fully at-home test for syphilis in 2024.
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The FDA just approved the Teal Wand, a self-collection device for HPV testing that does not require a speculum exam or even a trip to the doctor’s office. People can collect their own sample at home and send it to a lab for analysis.
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ASHA believes that all people have the right to the information and services that will help them to have optimum sexual health. We envision a time when stigma is no longer associated with sexual health and our nation is united in its belief that sexuality is a normal, healthy, and positive aspect of human life.
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