People looking to stay on top of their sexual health will now have a new tool at their disposal. Over the weekend, the Food and Drug Administration (FDA) authorized the first at-home, over-the-counter test for syphilis. The decision comes at a prudent time as the U.S. has been experiencing a steady increase in syphilis cases.
NOWDiagnostics developed the product, which will be sold as the First To Know Syphilis Test. Though there have previously been tests that people could take at home for syphilis, these have typically required the person to send samples to a lab for the actual results as well as approval from a physician. According to the FDA, this is the first at-home, OTC test for the sexually transmitted bacterial infection to be authorized in the U.S. The test looks for antibodies to syphilis in a finger prick’s worth of blood, with results usually provided in about 15 minutes. Compared to three FDA-cleared lab tests, the First To Know Syphilis Test was able to correctly identify over 99% of negative results and over 93% of positive results in a study of 1,207 people.
“We continue to see advancements in tests, particularly tests for sexually transmitted infections, which can give patients more information about their health from the privacy of their own home,” said Michelle Tarver, acting director of the FDA’s Center for Devices and Radiological Health, in the FDA’s announcement of the authorization Friday. “Access to home tests may help increase initial screening for syphilis, including in individuals who may be reluctant to see their health care provider about possible sexually transmitted infection exposure. This can lead to increased lab testing to confirm diagnosis, which can result in increased treatment and reduction in the spread of infection.”
Syphilis is caused by the bacteria Treponema pallidum. In adults, the infection can initially cause painless sores near the site of infection, such as the genitals, rectum, or mouth. The sores usually heal after a few weeks, but people can then experience a secondary stage of illness involving skin rashes, swollen lymph nodes, and fever. While these symptoms go away on their own, the infection will enter a latent period if not treated with antibiotics. Some people with latent syphilis will experience a tertiary stage of illness years to decades later that causes severe damage to the body’s organs, including the brain. The infection can also be passed from mother to child through the womb, raising the risk of miscarriage, stillbirth, congenital defects, and premature delivery. Infants born with syphilis can also become severely ill or die as a result.
For years, the U.S. has seen growing case numbers of the three major STIs in the country: gonorrhea, chlamydia, and syphilis. And while the situation may have recently improved with the former two, the rise in syphilis and congenital syphilis has continued. According to the latest official data, there were more than 200,000 reported cases of syphilis in 2022— well above the nearly 174,000 cases in 2021 and the highest tally seen since 1950. This includes 3,755 cases of congenital syphilis, which led to 231 stillbirths and 51 infant deaths.
While the First To Know Syphilis Test is intended to help combat this crisis, it has its limitations. Since the test detects antibodies to syphilis bacteria, it can potentially detect acute infections as well as latent infections that go unnoticed. But it may also detect past infections that were already successfully treated. The test is also explicitly intended to only be a screening tool. So people who obtain a positive result are still advised to seek further care from their doctor and get a second test to confirm their diagnosis. According to NOWDiagnostics, the First To Know Syphilis Test is expected to hit store shelves sometime in the second half of 2024.
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