The Food and Drug Administration has approved the first at-home syphilis test as cases rise in the U.S.
The First To Know Syphilis Test from NOWDiagnostics provides an at-home result in 15 minutes without the need for a prescription. Prior to the approval, there was no over-the-counter method to test for syphilis.
This comes as syphilis cases in the U.S. grew 80% between 2018 and 2022, according to the Centers for Disease Control and Prevention.
“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 a press release.
“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,” Tarver said.
Syphilis is a preventable and curable bacterial sexually transmitted infection, but can cause serious issues if left untreated, according to the World Health Organization.
Often, symptoms of syphilis — which has several stages — can go unnoticed. In the first phase of infection, a “round, painless, usually hard sore (chancre) appears on the genitals, anus or elsewhere,” the WHO said. Symptoms in the second phase include an itchy rash, usually on the palms and soles of the feet.
Symptoms may seem to go away in subsequent phases of infection, but conditions become more serious if the infection isn't treated.
If left untreated, syphilis can cause severe heart and brain damage, blindness, deafness and paralysis, the FDA warned.
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The FDA said the over-the-counter test alone is not enough to diagnose an infection, and should be followed up with additional laboratory testing through a health care provider.
Results of the at-home test will show up positive for anyone previously diagnosed with syphilis, even if it was treated.
“Results of the test alone should not be used to start, stop or change any treatments without a health care provider,” the FDA said. “In addition, individuals using this test who may have been recently exposed to syphilis should seek care from a health care provider for treatment and evaluation regardless of this test’s results.”
Risks associated with the test include a false negative or false positive result.
Earlier in the year, the Department of Health and Human Services established the National Syphilis and Congenital Syphilis Syndemic Federal Task Force in response to the rising number of syphilis and congenital syphilis cases in the U.S.
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