First At-Home Syphilis Test Receives Marketing Authorization From the FDA

The first blood-based, OTC test (First To Know Syphilis Test; NOWDiagnostics) to detect treponema pallidum (syphilis) antibodies was granted marketing authorization from the FDA in response to a surge of syphilis and congenital syphilis cases in the US since 2018. In a news release, FDA officials expressed hope that the product will improve access to at-home sexually transmitted disease (STI) testing and increase initial screening for syphilis, reducing the spread or worsening of the infection.

Officials advise that results from the OTC test are followed by additional testing with a health care professional to confirm diagnosis and need for treatment. Image Credit: © Jo Panuwat D - stock.adobe.com

Syphilis is a bacterial infection spread through sexual contact with an infected individual, specifically through direct contact with sores on the mouth, genitals or rectum. These sores, called canchre, are often painless and heal within 3 to 6 weeks, meaning some individuals may be unaware they are infected. Syphilis can stay in the body for many years without causing symptoms; however, it can become active at any time. If left untreated, syphilis can cause significant damage to the brain, heart, and other organs, resulting in blindness, deafness, or paralysis.¹

Syphilis can also be passed down from pregnant individuals to their unborn babies, which is called congenital syphilis. This infection is spread through the placenta or during birth. Some newborns have no symptoms, but others might get sores or rashes, fever, jaundice, anemia, or a swollen spleen and liver. Pregnant individuals should get tested for syphilis at their first prenatal appointment to prevent risk of miscarriage and lifelong health complications.¹

Fortunately, syphilis is curable and easily treated with a single shot of penicillin and can be used for both syphilis and congenital syphilis. This means early detection is crucial for reducing the spread of the infection, as well as its progression in affected individuals. In response to growing cases of syphilis, the Department of Health and Human Services established the National Syphilis and Congenital Syphilis Syndemic (NSCSS) Federal Task Force. The authorization of the antibody blood test contributes toward the department’s STI National Strategic Plan, which aims to reverse the rise of STIs in the US.^1,2

The at-home test is capable of detecting syphilis antibodies in the blood and can give results in approximately 15 minutes. The FDA emphasizes that this test alone is not sufficient to diagnose infection, as results of the test can detect syphilis even in successfully treated individuals. Additionally, there is the possibility of false positive and false negative test results. Officials advise that results from the OTC test are followed by additional testing with a health care professional to confirm diagnosis and need for treatment.^2,3

“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, MD, PhD, acting director of the FDA’s Center for Devices and Radiological Health, said in a news release. “This can lead to increased lab testing to confirm diagnosis, which can result in increased treatment and reduction in the spread of infection.”²

REFERENCES

1. Syphilis. Mayo Clinic. July 20, 2024. Accessed August 19, 2024. https://www.mayoclinic.org/diseases-conditions/syphilis/symptoms-causes/syc-20351756

2. Fda marketing authorization enables increased access to first step of syphilis diagnosis. FDA. August 16, 2024. Accessed August 19, 2024. https://www.fda.gov/news-events/press-announcements/fda-marketing-authorization-enables-increased-access-first-step-syphilis-diagnosis

3. Fda approves first over-the-counter syphilis test. Contemporary OB/GYN. August 16, 2024. Accessed August 19, 2024. https://www.contemporaryobgyn.net/view/fda-approves-first-over-the-counter-syphilis-test