The Food and Drug Administration (FDA) Granted The first home syphilis test kit has been approved for sale in the United States, amid a decades-long rise in syphilis cases.
The test detects syphilis antibodies in human blood and provides results within 15 minutes.
“Having access to at-home tests could help increase early screening for syphilis, including among people who may be reluctant to talk to their health care provider about a possible sexually transmitted disease,” Michelle Tarver, acting director of the FDA’s Center for Devices and Radiological Health, said in the announcement.
“This could lead to increased laboratory testing to confirm the diagnosis, potentially leading to increased treatment and reduced spread.”
The U.S. Centers for Disease Control and Prevention (CDC) reports an 80 percent increase in syphilis cases between 2021 and 2022. According to the World Health Organization (WHO), syphilis cases among adults aged 19-45 years have increased by more than one million worldwide, with a surge in positive cases in Africa and the Americas.
Syphilis is a curable sexually transmitted disease, but if left untreated, it can cause serious health problems, including damage to the heart and brain, leading to paralysis and blindness.
The infection can also be spread from mother to child during pregnancy, which can lead to miscarriage, lifelong health problems and infant death.
The CDC has confirmed a three-fold increase in syphilis cases during pregnancy in the United States between 2016 and 2022. In response to this study, the American College of Obstetricians and Gynecologists has issued new guidelines recommending that pregnant individuals get tested for syphilis three times during their pregnancy.
The new test alone is not sufficient to diagnose syphilis, and the FDA recommends that additional testing be performed by a health care provider to confirm the diagnosis.
