FDA Approves First At-Home Syphilis Test

A model of a billboard from the AIDS Healthcare Foundation (AHF) which ran in Los Angeles earlier this year but has been rejected to be displayed in many other cities is seen at the AHF office in Hollywood, California on May 18, 2018. - A billboard on Sunset Boulevard in Hollywood screams out a stark warning: "drug-resistant gonorrhea alert!" Sexually transmitted diseases have made an alarming resurgence across the US, where 2016 saw a record two million cases of chlamydia, gonorrhea and syphilis, including 628 cases of congenital syphilis. But California, the most populous US state, stands out for its willingness to tackle the crisis head-on, with cases of the three ailments up 45 percent in 2017 from five years ago. (Photo by Frederic J. BROWN / AFP) / TO GO WITH AFP STORY by Javier TOVAR, "California on front line as STDs run rampant in US" (Photo credit should read FREDERIC J. BROWN/AFP via Getty Images)
A model of a billboard from the AIDS Healthcare Foundation (AHF) which ran in Los Angeles earlier this year but has been rejected to be displayed in many other cities is seen at the AHF office in Hollywood, California on May 18, 2018. (Photo credit should read FREDERIC J. BROWN/AFP via Getty Images)

OAN Staff Abril Elfi
4:23 PM – Sunday, August 18, 2024

The Food and Drug Administration (FDA) have given the green light to the first at-home syphilis test amid a rise of cases in the U.S.

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Dr. Michelle Tarver, acting director of the FDA’s Center for Devices and Radiological Health released an announcement regarding the tests. 

“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,” she said. “This can lead to increased lab testing to confirm diagnosis, which can result in increased treatment and reduction in the spread of infection.”

The test, which detects syphilis antibodies in human blood, will provide a result within 15 minutes of taking it. 

According to the Centers for Disease Control and Prevention (CDC), the number of syphilis cases increased by 80% between 2021 and 2022. 

The World Health Organization (WHO) reported that among adults 19 to 45-years-old, the number of syphilis cases has increased by over a million worldwide, with positive cases peaking in Africa and the Americas.

If left untreated, the treatable sexually transmitted infection syphilis can lead to major health issues, such as brain and cardiac damage that can result in blindness and paralysis.

Additionally, the infection can pass from mother to child while a woman is pregnant, increasing the risk of miscarriage, chronic health problems, and infant death.

The CDC reported that the number of cases involving expectant mothers in the United States tripled between 2016 and 2022. The American College of Obstetricians and Gynecologists released new guidelines after the study, advising expecting mothers to get screened for syphilis three times during their pregnancy.

The FDA suggests that in order to confirm the diagnosis of syphilis, further testing with a medical professional should be conducted after taking the new test.

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