The first at-home syphilis test has been approved for sale in the United States. The worsening epidemic And the number of infected people has been increasing for decades.
The U.S. Food and Drug Administration on Friday approved NOWDiagnostics’ 15-minute test for sale in the United States.
The commercially available First To Know syphilis test kit will cost $29.98 per box and will be available at major retailers in the fall. According to reports.
But health officials warn that the test alone is not enough to diagnose an STI and additional testing must be done to confirm it.
The FDA said that prior to its approval, there were no commercially available tests for syphilis infection. News release.
“The availability of at-home tests could help increase early screening for syphilis, including among people who may be reluctant to talk to their health care provider about possible exposure to a sexually transmitted disease,” said Michelle Tarver, acting director of the FDA’s Center for Devices and Radiological Health.
“This could lead to increased laboratory testing to confirm the diagnosis, leading to increased treatment and reduced spread,” she added.
The new test uses a drop of blood to show early signs of syphilis, instead of the previously required blood tests or tests of fluids from syphilis wounds.
The Centers for Disease Control and Prevention reported that between 2018 and 2022, syphilis cases will increase 80%, from 115,000 to more than 207,000.
In 2022, More than 2.5 million cases of syphilisGonorrhea and chlamydia infections have been reported in the United States.
In response to the surge in cases, the Department of Health and Human Services established the National Syphilis and Congenital Syphilis Syndrome Federal Task Force earlier this year.
The at-home tests are part of the Department of Health’s strategic plan aimed at reversing the “dramatic increase” in sexually transmitted diseases in the United States.
According to the CDC, if left untreated, syphilis can cause severe damage to the heart and brain, and can lead to blindness, deafness, and paralysis.
Infection during pregnancy can cause miscarriage, lifelong health problems, and infant death.
It can also be transmitted sexually and, more rarely, through blood transfusions and organ transplants.
Experts say sexual transmission only occurs in the early stages of life, around four months of age, but the virus can be transmitted to the fetus at any stage.
This alarming increase began in 2000 and was initially seen among gay men, but has since grown to include heterosexual drug users as well. There has also been an increase among women.
The highest rates are among black and American Indian populations, According to Johns Hopkins University.
Public health officials say insufficient testing and persistent stigma are hindering progress in defeating the epidemic.
Dr. Nima Majlesi, director of medical toxicology at Staten Island University Hospital, told The Washington Post in January that condom use is also declining.
The disease has become less common in recent decades and is therefore less recognized by doctors.
In the 1990s, the number of annual cases fell below 40,000.
