The FDA Just Approved Another At-Home Test For STIs — This One For Syphilis

Last week, the Food and Drug Administration (FDA) authorized the first at-home, OTC test to detect syphilis — a much-needed diagnostic tool for an infectious disease that has experienced a spike in case counts over the past several years.

Syphilis is a sexually transmitted infection that first manifests as small, pimple-like sores around the genitals or in the mouth, which can linger for weeks to months and evolve into a rough red or brown rash.

Arkansas-based NOWDiagnostics’ First To Know Syphilis Test is a home-use fingerstick blood test that detects antibodies to Treponema pallidum, the bacteria that cause syphilis. Antibodies are protective proteins that the immune system produces to eliminate deleterious, invading microbes in the body. The test works within 15 minutes.

While the test is over 93 percent accurate at identifying syphilis in someone who has it and over 99 percent accurate at revealing a negative result in someone who doesn’t, right now, a positive result still means you’ll need to follow up with a doctor. The presence of antibodies indicates that you either currently have syphilis or have had it in the past. So if you test positive, NOWDiagnostics recommends a following up with a doctor to confirm the results.

Syphilis is curable with antibiotics, commonly penicillin. But left untreated, the infection can damage the heart and brain. It can also cause deafness, blindness, and paralysis. If pregnant, someone with syphilis can also pass the infection to their fetus in a condition called congenital syphilis.

This is the second at-home test to detect sexually transmitted diseases in the past year. Last November, the FDA authorized a home test that detects both chlamydia and gonorrhea. And it’s coming at an important time: In January, the Centers for Disease Control and Prevention reported that between 2018 and 2022, syphilis cases rose from 115,000 to over 207,000, which is an 80 percent jump.