• The FDA has recently greenlit an at-home testing kit for two prevalent sexually transmitted infections (STIs) and one sexually transmitted disease (STD).
  • This new test, which checks for chlamydia, gonorrhea, and trichomoniasis, delivers results in just 30 minutes.
  • Health experts highlight the advantage of this kit, which provides a means for discreet STD testing at home.

The Food and Drug Administration (FDA) has endorsed the first over-the-counter, at-home test kit for three frequently occurring STIs and STDs.

The product, known as the Visby Medical Women’s Sexual Health Test, can detect chlamydia, gonorrhea, and trichomoniasis.

Targeted at women, whether symptomatic or not, this test promises results within half an hour.

Representatives from Visby have informed Healthline that they plan to release the test to the market in the upcoming months, with pricing details to be announced at that time.

The kit includes a single-use collection device (vaginal swab) and a testing apparatus that operates with the Visby Medical App, which displays the results once the test is complete.

According to FDA sources, recent clinical trials have shown that the Visby home test accurately identified over 98% of negative and more than 97% of positive samples for the three diseases.

The FDA assessed this new product under its De Novo premarket review pathway, a process that facilitates the swift approval of medical devices posing low to moderate risk. This clearance further paves the way for similar future devices to expedite their market entry by demonstrating comparability to the Visby test.

“This approval represents not only a significant achievement for Visby Medical but also a pivotal moment in the evolution of medical diagnostics,” remarked Adam de la Zerda, PhD, the CEO and founder of Visby Medical, in a press release.

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Currently, there are various at-home test kits for both men and women targeting syphilis, chlamydia, gonorrhea, and trichomoniasis, though they require blood and/or urine samples and lack the integrated app feature of Visby’s latest offering.

The Impact of At-Home STI Testing

The Centers for Disease Control and Prevention (CDC) revealed that in 2023, the U.S. saw 2.2 million diagnosed cases of chlamydia and gonorrhea.

Additionally, 2.6 million cases of trichomoniasis were confirmed in the same year.

The CDC also noted a significant rise in syphilis cases, reporting over 200,000 incidents in 2022, marking the most since 1950.

Experts stress the importance of at-home tests since timely medical intervention is crucial for treating these infections effectively with antibiotics. Without treatment, these conditions can lead to severe complications, including infertility.

The accuracy of these tests is critical; a false negative could delay necessary treatment, while a false positive might lead to unnecessary interventions and delay the correct diagnosis of any other potential health issues.

“Home testing kits offer a confidential way to learn about one’s health status, which is especially vital for sexual health where fear or stigma may prevent timely medical advice,” noted Courtney Lias, PhD, from the FDA’s Office of In Vitro Diagnostic Devices.

“Improving access to STI testing can lead to earlier diagnosis, more timely treatment, and potentially a reduction in the spread of infections,” she added.

Lisa Valle, DO, an OB-GYN at Oasis Women’s Sexual Function Center, believes that at-home tests could boost STD screening rates.

“Testing from home can significantly increase privacy and comfort, leading to more people getting tested,” Valle explained to Healthline.

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However, Valle warns of the potential emotional and medical challenges of receiving a positive diagnosis alone at home without immediate professional support.

She also expressed concern over individuals who might overlook symptoms after receiving a negative home test result, potentially missing other critical diagnoses.

Understanding Chlamydia, Gonorrhea, and Trichomoniasis

STIs are infections caused by bacteria, viruses, or parasites, often without noticeable symptoms.

While not all STIs become STDs, those that do often show symptoms and require medical intervention.

All these conditions are diagnosable through simple tests and treatable with antibiotics.

Chlamydia is commonly spread through unprotected oral, vaginal, or anal sex. It often shows no symptoms, but when it does, symptoms might include a burning sensation during urination, abnormal discharge, genital sores, or rectal pain.

Gonorrhea is more prevalent among teenagers and young adults aged 15-24. It’s also spread through unprotected sex, with symptoms typically appearing between 2 to 30 days after exposure. Symptoms can include pain during urination, unusual discharge, and swelling in the genital area.

Trichomoniasis usually remains symptom-free in about 70% of those affected. When symptoms occur, they may include unusual discharge, vaginal bleeding or spotting, and frequent urination.

Valle emphasizes the importance of testing for these infections, recommending testing before and after entering a new sexual relationship to help control the spread of these diseases.

“Frequent testing is key to reducing the transmission of these infections,” she concluded.