Antibiotic can help prevent common sexually transmitted infections
FDA Clears OTC Test For Chlamydia, Gonorrhea And Trichomoniasis
The Food and Drug Administration (FDA) has cleared the Visby Medical Women's Sexual Health Test for use at home to test for chlamydia, gonorrhea and trichomoniasis.
The single-use, polymerase chain reaction (PCR) diagnostic test is intended for females with or without symptoms. It consists of a collection kit (self-collected vaginal swab) and a powered testing device. Test results are delivered in approximately 30 minutes; the Visby Medical App guides users through the testing process and helps interpret the results.
The approval was based on a clinical study that included 2203 females aged 14 years and older. Study participants followed the instructions of the test and collected a sample via vaginal swap that was then tested using the Visby Medical Women's Sexual Health Test. Additional swabs were also taken for comparator testing.
Results showed Visby Medical Women's Sexual Health Test had a sensitivity of at least 95% (correctly identified 95.2%, 100%, and 96.4% of positive Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis samples, respectively) and a specificity of at least 98% (correctly identified 99%, 99.3%, and 98.4% of negative Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis samples, respectively). Accuracy was found to be comparable to traditional laboratory-based PCR machines. Additionally, lay users were able to successfully perform the test based on findings from human factors usability studies.
"The clinical significance of bringing a rapid, highly accurate PCR diagnostic test into the home environment cannot be overstated," said Gary Schoolnik, MD, Chief Medical Officer of Visby Medical. "Extensive clinical studies validate that this test empowers women to quickly understand what steps to take next, giving them the privacy, control, and confidence to seek the care they need. Importantly, many patients infected with these STIs are non-symptomatic, yet they can still suffer serious long-term health consequences. Our test directly addresses this silent epidemic by enabling detection and treatment."
FDA Authorizes First At-Home Test For Chlamydia, Gonorrhea: What To Know
The Food and Drug Administration (FDA) recently approved the first at-home test for three common sexually transmitted infections and diseases that can be purchased without a prescription.
The test is designed for females with or without symptoms of these three infections. Results are delivered within 30 minutes.
Visby officials told Healthline they expect the new test to be available in a few months and will announce pricing then.
The Visby product is a single-use test that includes a collection kit (vaginal swab) and a powered testing device that communicates with the Visby Medical App. The app displays results when the test is complete.
FDA officials reported that in recent clinical studies the Visby at-home test correctly identified more than 98% of negative samples for the three STDs and more than 97% of positive samples.
The FDA reviewed the product under the agency's De Novo premarket review pathway, which allows low-risk to moderate-risk devices to be approved quickly. This authorization also allows other devices to go through the FDA's 510 (k) premarket notification process for quick approval by proving their similarity to the Visby product.
"This approval is not just a milestone for Visby Medical but marks a transformative moment in medical diagnostics," said Adam de la Zerda, PhD, founder and chief executive officer of Visby Medical, in a press statement.
These tests are specific to these individual infections and involve collecting blood and/or urine samples. The products include the Visby Medical Sexual Health Test, which lacks the app that the new product contains.
In its annual surveillance report released last year, the CDC also reported there were more than 200,000 cases of syphilis diagnosed in the U.S. In 2022, the highest number since 1950.
Experts say at-home tests are important because people with STIs need to seek medical treatment quickly. Antibiotics are effective in treating these infections, but untreated STIs may lead to serious health issues, including infertility.
They add that test accuracy is also important because a false negative result can delay treatment. A false positive result can lead to unnecessary treatments and a potential delay in correctly diagnosing another infection or disease.
"Home tests can give people information about their health from the privacy of their home. This can be particularly important for sexual health tests for which patients may experience fear or anxiety, possibly resulting in delayed diagnosis or treatment," said Courtney Lias, PhD, the director of the Office of In Vitro Diagnostic Devices in the FDA's Center for Devices and Radiological Health, in an FDA press release.
"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."
Lisa Valle, DO, OB-GYN and medical director of Oasis Women's Sexual Function Center in Santa Monica, CA, said at-home kits have the ability to increase the number of people who test for STDs.
"More people are apt to test in the privacy of their homes," Valle told Healthline.
She noted that increased testing can help reduce the spread of STDs and lead to earlier treatments.
She does caution, however, that a person can receive a positive result while alone in their home without anybody to talk to or counsel them.
"There are medical and emotional issues they could be dealing with without the help of a healthcare professional," she said.
Valle added that there are potential issues for someone who receives a negative test result at home. They can be satisfied there isn't anything wrong with them despite having symptoms and not getting tested for other illnesses or conditions.
Some — but not all — STIs can develop into a sexually transmitted disease (STD). These diseases do produce symptoms in many people.
All can be diagnosed with basic tests and treated with antibiotics.
Chlamydia is usually transmitted through oral, vaginal, or anal sex without a condom or other barrier protection.
Some people who have chlamydia don't have symptoms. When symptoms do appear, they can include:
Gonorrhea can affect anybody, but it is most common among teens and young adults between the ages of 15 and 24.
It is also transmitted through oral, vaginal, and anal unprotected sex.
Symptoms usually appear 2 to 30 days after exposure. They include:
Trichomoniasis causes symptoms in only about 30% of people with the disease.
When symptoms do appear, they include:
Valle said it is that important people get tested either at home or in a medical facility if they develop these symptoms.
She recommends that people get tested before and after they get involved with a new romantic partner.
"Overall, testing does help decrease the spread of these diseases," she said.
FDA Approves First At-home Test To Diagnose Three STIs In Women
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