FDA authorizes first over-the-counter syphilis test to use at home

Morayo Ogunbayo | (TNS) The Atlanta Journal-Constitution

Worried you might have syphilis but are afraid to go to a clinic? Now you can get tested at home.

The Food and Drug Administration has authorized the first over-the counter antibody test for detecting syphilis in human blood. The move is an effort to stall the recent increase in cases within the United States.

This new test will be available without a prescription and inform the user of their status within 15 minutes, according to the FDA. The test is just an indicator of syphilis antibodies, however. Anyone who tests positive should see their doctor.

Between 2018 and 2022, the Atlanta-based Centers for Disease Control and Prevention reported an 80% increase in syphilis cases within the U.S., moving from 115,000 cases to more than 207,000, a development that had been part of a decades-long trend.

Syphilis, if left untreated, can cause heart damage, brain damage, deafness, blindness and paralysis. If the transmission happens during pregnancy, it can cause a miscarriage, or lifelong or terminal health issues for infants.

“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,” Michelle Tarver, M.D., Ph.D., director of the FDA’s Center for Devices and Radiological Health, said in a statement. “This can lead to increased lab testing to confirm diagnosis, which can result in increased treatment and reduction in the spread of infection.”

Today, medical professionals are well-versed in treating syphilis, and typically a penicillin-based treatment is all it takes to recover from this sexually transmitted illness. With increased access to over-the-counter test kits, the hope is fewer Americans will unknowingly spread this disease.

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