The U.S. Food and Drug Administration (FDA) on Friday approved the first over-the-counter test to detect syphilis antibodies in human blood.
The “First To Know Syphilis Test” is produced by the Arkansas-based NOWDiagnostics and is able to provide results within 15 minutes from a single drop of blood. The new test promises to provide a more private option for people who believe they were exposed to the sexually transmitted infection.
Still, the FDA notes that the test alone is not sufficient to diagnose a syphilis infection and should be followed by additional testing and a consultation with a healthcare provider.
“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,” said Michelle Tarver, the director of the FDA’s Center for Devices and Radiological Health, in a press release. “This can lead to increased lab testing to confirm diagnosis, which can result in increased treatment and reduction in the spread of infection.”
The FDA approved the test following a clinical trial that found it was able to identify 93.4% of positive specimens when compared to three FDA-cleared laboratory tests.
“Testing is one of the most important tools we have in preventing the spread of sexually transmitted infections, and for the first time ever, consumers now have a fast and simple syphilis test that can be performed in the privacy of one’s home, with a result in minutes,” said NOWDiagnostics CEO Rob Weigle in a statement.
The approval comes as reported syphilis cases increased 80% in the United States between 2018 and 2022, according to the U.S. Centers for Disease Control and Prevention (CDC).
If left untreated, syphilis can cause severe damage to the heart and brain and can lead to blindness, deafness and paralysis, the FDA said.
NOWDiagnostics plans to make its test available at major retailers and online in the second half of the year.