FDA approves first at-home, over-the-counter test for STIs. But there's a catch.
Show Caption
Hide Caption
Where to get tested for STIs
Sexually transmitted infections are on the rise. Here's where to get properly tested.
Self Improved, Self Improved
The U.S. Food and Drug Administration (FDA) has approved the first-ever testing kit for sexually transmitted infections that can be taken at home without a prescription. But it's not for everyone.
The FDA granted marketing authorization for the diagnostic test, the Visby Medical Women's Sexual Health Test, to Visby Medical on Friday. The at-home kit, according to the FDA, is the first of its kind to test for chlamydia, gonorrhea and trichomoniasis, three of the most common STIs with symptoms that often go unnoticed.
The kit is intended for use in female patients with or without symptoms. It is single-use and includes a vaginal swab and a powered testing device that connects to the Visby Medical App. Results are displayed on the app about 30 minutes after testing.
An FDA press release issued Friday said the test was 97% to 100% accurate when identifying the presence or absence of the three STIs in women with or without symptoms. The release advised that those who test positive should seek medical care and those who have symptoms, recent exposure or other concerns should still contact their healthcare provider even if they get a negative result.
'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,' Courtney Lias, director of the Office of In Vitro Diagnostic Devices in the FDA's Center for Devices and Radiological Health, 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.'
The approval of this test opens the pathway for more at-home STI testing in the future, said the statement.
At-home test tackles three most common STIs
Chlamydia, gonorrhea and trichomoniasis are three of the most prevalent STIs in the U.S.
Both chlamydia and gonorrhea are bacterial infections, while trichomoniasis is caused by a parasite. Gonorrhea can cause infection in the genitals, rectum and throat and often has no symptoms, according to the Centers for Disease Control and Prevention (CDC). Chlamydia is also typically asymptomatic but can cause permanent damage to a woman's reproductive system.
Trichomoniasis is caused by a one-celled protozoan, a type of tiny parasite called Trichomonas vaginalis. In 2021, the CDC reported that around 2.6 million Americans had been infected with trichomoniasis. Up to 70% of people have no symptoms when infected.
According to the CDC's (STI) Surveillance Report, 601,319 cases of gonorrhea were reported in the U.S. in 2023, making it the second most common STI in the country. There were more than 1.6 million reported cases of chlamydia in the same year, making it the most common.
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Newsweek
24 minutes ago
- Newsweek
Nationwide Honey Recall Update as FDA Issues Risk Warning
Based on facts, either observed and verified firsthand by the reporter, or reported and verified from knowledgeable sources. Newsweek AI is in beta. Translations may contain inaccuracies—please refer to the original content. Food inspectors have designated a nationwide recall of hundreds of honey products as the second-highest of three risk levels. Queen Bee Gardens, a company in Wyoming, issued a voluntary recall on July 16 of hundreds of jars of its whipped honey products after internal checks raised concerns that some batches could contain small flakes of stainless steel. On August 1, the U.S. Food and Drug Administration categorized the recall as Class II. Newsweek contacted Queen Bee Gardens via its general inquiries email on Monday outside normal working hours. Why It Matters The FDA's classification of the Queen Bee Gardens recall as Class II signals a moderate health risk, indicating that use or exposure to the affected products may cause temporary or medically reversible adverse health consequences, while the probability of serious adverse health consequences is remote. What To Know Queen Bee Gardens, based in Lovell, voluntarily recalled these affected products: 129 jars of QBee Whipped Honey Raspberry with the UPC 788394182358 112 jars of QBee Whipped Honey Pure with the UPC 788394182006 24 jars of QBee Whipped Honey Huckleberry with the UPC 788394182259 According to the FDA notice, the QBee Whipped Honey Raspberry and QBee Whipped Honey Pure products have the lot codes 206235 and were made on June 23. The QBee Whipped Honey Huckleberry has the lot code 206305 and was made on June 30. The recall covers jars distributed throughout the United States. Consumers are urged to discontinue use of the affected honey immediately. Stock image shows dripping honey. Stock image shows dripping honey. Getty Images What People Are Saying The U.S. Food and Drug Administration said of the recall risk categories on its website: "Class I—a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death. "Class II—a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. "Class III—a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences." What Happens Next The recall of Queen Bee Gardens' honey products remains ongoing. Consumers in possession of the recalled jars are advised to discontinue use immediately and follow company or FDA guidance regarding returns or refunds. Consumers who experience any health concerns related to the ingestion of these or similar products are encouraged to consult a medical professional and report the incident to the FDA's MedWatch program.
Axios
an hour ago
- Axios
Colorado kindergartners' vaccine rates lag in 2025
Vaccination rates among Colorado kindergartners stayed stubbornly low during the 2024-2025 school year, new CDC data shows. Why it matters: The stagnation comes as U.S. measles cases reach a 33-year high, and Health Secretary Robert F. Kennedy Jr. challenges long-standing vaccine norms ahead of the start of school. By the numbers: 4.2% of Colorado kindergartners were exempt from one or more vaccines — unchanged from last year and above the national average of 3.6%. Colorado's goal for herd immunity is 95% coverage for core vaccines like MMR, which protects against measles, mumps and rubella. Last school year, Colorado kindergartners' MMR coverage was 88%, Polio was 87.6% and DTaP was 87.4%. Only Hepatitis B topped 90%.
New York Post
an hour ago
- New York Post
New study reveals when most Americans fall asleep — you'll never guess the time
Is there a 'prime' bedtime? A new study found the average American falls asleep at 11:18 p.m. A new survey of 2,000 general population Americans explored respondents' nighttime routines and sleep habits — digging into their bedtimes. Advertisement The results found that the average respondent begins their nighttime routine at 10:15 p.m., taking 21 minutes to get ready for bed, on average — meaning respondents are then tucked into bed by 10:36 p.m. But it takes about forty minutes before they actually fall asleep, as results revealed the average American doesn't drift off until about a quarter past 11 o'clock. 5 A new survey of 2,000 general population Americans explored respondents' nighttime routines and sleep habits — digging into their bedtimes. New Africa – Conducted by Talker Research on behalf of Avocado Green Mattress, the survey found respondents have three mornings per week when they wake up wishing they went to bed earlier the night before. Advertisement For those who end up staying awake later than planned, respondents said they're kept up because of chores and other things they need to take care of (29%). A fifth said they stay up late because night is their favorite time of the day (21%). Others said they don't want to go to sleep and 'fast forward' to the next workday (15%) — or that it's the only time they have during the week to connect with their partner (13%). 5 The new study found the average American falls asleep at 11:18 p.m. SWNS Advertisement The survey also looked at how respondents sleep — or don't sleep — with their partner. Of respondents who share a bed with their significant other (46% of the sample), only half (49%) sleep better due to having their partner asleep next to them. On the other hand, one in seven (14%) of these respondents sleep worse, largely due to their partner's snoring (63%). 5 One in seven of these respondents sleeps worse with a partner, largely due to their partner's snoring. SWNS Advertisement Their partner waking them up during the night (tossing/turning, getting up to use the bathroom, etc.) (52%), generally having different nighttime routines (26%), and sleeping at different temperatures (24%) also contributed to poorer sleep when sharing a bed. 'For many, falling asleep and staying asleep is difficult,' said Laura Scott, director of brand marketing at Avocado Green Mattress. 'And perfectly controlling your bedtime or wind-down routine isn't always possible, since life, and sometimes other people, often get in the way. That's why having a cozy, personalized, and supportive sleep environment is so vital for a good night's rest.' With back-to-school season quickly approaching, the survey also asked parents how they anticipate this return to the classroom will impact their sleep. 5 Half of these respondents said they'll need to wake up earlier, while a quarter said they'll be going to sleep later — as they need to make lunches in the evening, help their kids with homework, etc. SWNS Parents of school-aged children (27% of the sample) said, largely, they'll get less sleep when their child goes back to school. Half (53%) of these respondents said they'll need to wake up earlier (to help get their kids ready for school, drive them to school, etc.), while a quarter said they'll be going to sleep later — as they need to make lunches in the evening, help their kids with homework, etc. And one in 10 (11%) won't sleep as well, as they have more to worry about with their child returning to school. 5 The results found that the average respondent begins their nighttime routine at 10:15 p.m., taking 21 minutes to get ready for bed, on average. Gorodenkoff – Advertisement 'Parents with kids in school can have an even harder time getting all the sleep they need, since they're making time for homework, packing lunches and making meals, driving here and there, and trying to spend quality time with their kids,' said Scott. 'With so much going on during back-to-school season, ensuring they can get a full, restful night of sleep is more important than ever.' Survey methodology: Talker Research surveyed 2,000 general population Americans; the survey was commissioned by Avocado Green Mattress and administered and conducted online by Talker Research between June 23–27, 2025.
