CLEVELAND, Ohio — Americans can now test for syphilis using the first at-home, over-the-counter test to be approved for this sexually transmitted infection.
The U.S. Food and Drug Administration recently gave NOWDiagnostics permission to market the First To Know Syphilis Test, which can detect syphilis antibodies in blood.
However, results from the home tests alone are not enough for a diagnosis; additional testing is needed to confirm that a person has syphilis, the FDA said.
The at-home syphilis test, which is available without a prescription, gives results in about 15 minutes. Other at-home syphilis tests currently on the market require consumers to send their sample to a lab, the FDA said.
The at-home syphilis tests are expected to be available at major retailers and online in late 2024, and cost about $30, according to news reports.
The FDA’s approval comes in response to the rise in syphilis cases in the United States. Some people might be reluctant to seek care for possible exposure to a sexually transmitted infection, the federal agency said.
“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 Dr. Michelle Tarver, acting director of the FDA’s Center for Devices and Radiological Health.
If left untreated, syphilis can cause blindness, deafness and paralysis, and seriously damage organs. When transmitted during pregnancy, it can cause miscarriage, lifelong medical issues and infant death.
People who were previously diagnosed with syphilis will test positive on the NOWDiagnostics test, even if they were successfully treated, the FDA said.
In addition, those who have been recently exposed to syphilis should seek treatment, regardless of test results, the FDA said.
Syphilis cases are on the rise nationally.
Reported cases increased 80% in the United States from 2018 to 2022 (from 115,000 to more than 207,000), continuing a decades-long upward trend, according to the U.S. Centers for Disease Control and Prevention.
In Ohio, the number of syphilis cases dropped slightly, from 5,318 in 2022 to 4,974 in 2023, according to state data.
Syphilis is a sexually transmitted infection that can cause serious health problems if left untreated. Newborn, or congenital syphilis, occurs when the illness spreads from a mother with syphilis to her unborn baby.
Babies born with congenital syphilis can have deformed bones, low blood count, jaundice, brain and nerve damage, meningitis and enlarged liver and spleen, according to the CDC.
The number of babies born with syphilis increased more than tenfold from 2012 to 2022, putting moms and infants at risk for miscarriage and stillbirth, the CDC said.
Earlier this year, the Department of Health and Human Services established the National Syphilis and Congenital Syphilis Syndemic Federal Task Force to respond to the syphilis and congenital syphilis epidemic, the FDA said.
Julie Washington covers healthcare for cleveland.com. Read previous stories at this link.
