People looking to stay sexually healthy will now have a new tool at their disposal. Over the weekend, the U.S. Food and Drug Administration (FDA) approved the first over-the-counter at-home syphilis test. The decision comes at a time of caution as syphilis cases continue to rise in the United States.
NOWDiagnostics developed the product, which will be marketed as “the first test to understand syphilis.” While people have previously been able to get syphilis tests at home, these tests typically required people to send a sample to a lab to get actual results and get approval from a doctor. According to the FDA, this is the first at-home, over-the-counter test for a sexually transmitted bacterial infection authorized in the United States. Compared with three FDA-approved laboratory tests, the First To Know syphilis test correctly identified more than 99 percent of negative results and more than 93 percent of positive results in a study of 1,207 people.
Michelle Tarver, acting director of the FDA’s Center for Devices and Radiological Health, said: “We continue to see advances in testing, particularly for sexually transmitted infections, that allow patients to gain more access in the privacy of their own homes. information about their health. “Introduction to home testing may help increase initial screening for syphilis, including among individuals who may be reluctant to consult a health care provider about possible exposure to sexually transmitted infections. This may lead to increased laboratory testing. Testing to confirm diagnosis, thereby increasing treatment and reducing the spread of infection.
Syphilis is caused by bacteria Treponema pallidum. In adults, the infection initially causes painless sores near the site of infection, such as on the genitals, rectum, or mouth. Ulcers usually heal after a few weeks, but people may experience a second stage of illness including rash, swollen lymph nodes, and fever. Although these symptoms will go away on their own, if not treated with antibiotics, the infection will enter a latent stage. Some people with latent syphilis experience the third stage of the disease years to decades later, causing severe damage to body organs, including the brain. Infections can also be passed from mother to child through the uterus, increasing the risk of miscarriage, stillbirth, birth defects and premature birth. Babies born with syphilis may also become seriously ill or die from it.
Over the years, the number of cases of gonorrhea, chlamydia, and syphilis, three major sexually transmitted diseases, has increased in the United States. Although the situation for the first two may have improved recently, the incidence of syphilis and congenital syphilis continues to increase. More than 200,000 syphilis cases were reported in 2022, up from nearly 174,000 in 2021 and the highest number since 1950, according to the latest official figures. 51 stillbirths.
While First Look at Syphilis Testing is designed to help address the crisis, it has its limitations. Because the test detects antibodies to the syphilis bacteria, it can detect acute infections as well as latent infections that go unnoticed. But it can also detect past infections that have been successfully treated. The test is also expressly intended to be a screening tool only. Therefore, people who get a positive result are still advised to seek further care from their doctor and get a second test to confirm the diagnosis. The First To Know syphilis test is expected to hit store shelves sometime in the second half of 2024, according to NOWDiagnostics.