The first at-home syphilis antibody test has been authorized by the FDA as the number of STD cases in the US continues to rise.

The FDA has approved the first at-home syphilis test in the U.S.

NOWDiagnostics in Arkansas has created an over-the-counter First To Know Syphilis Test that detects antibodies for Treponema pallidum (syphilis), as stated in a press release.

The test, which is not a prescription, takes approximately 15 minutes to administer using only a drop of blood, similar to a finger prick, according to the company.

Those who currently have syphilis or have been previously diagnosed and successfully treated will experience positive results.

While the test results may suggest syphilis, a diagnosis cannot be confirmed without additional testing from a healthcare provider, as per the FDA.

NOWDiagnostics announced that a clinical study of 1,270 people found their product "easy to use," according to a press release.

The test accurately identified 99.5% of negative results and 93.4% of positive diagnoses, according to study results.

NOWDiagnostics CEO Rob Weigle announced that the company's first test, which provides highly accurate results in minutes using a single drop of blood and without the need for a buffer, has been granted FDA authorization.

"The new diagnostic testing technology allows individuals to manage their health at home, which is crucial for early detection and treatment, and ultimately helps to prevent the spread of syphilis and safeguard public health."

Dr. Nicole Saphier, a Planet Chronicle medical contributor, believes at-home tests are "great" because they increase the number of people getting tested, even those who wouldn't otherwise visit the doctor.

The New York-based doctor stated that anything that enhances access to health information while being affordable is a positive move in the right direction, as reported by Planet Chronicle Digital.

Efforts to stop the surge

The number of syphilis cases in the U.S. has significantly increased over the past few years.

The number of cases increased by 80% between 2018 and 2022, according to CDC data.

The agency reported over 3,700 cases of congenital syphilis among newborns in 2022.

The NSCSS Federal Task Force was established by the Department of Health and Human Services to address the increasing cases of syphilis.

The FDA assured that the authorization of this new at-home test will help to "reverse the recent dramatic increase of STIs in the United States."

The FDA stated in a press release that untreated syphilis can severely harm the heart and brain, resulting in blindness, deafness, and paralysis.

"If transmitted during pregnancy, it can lead to miscarriage, long-term health problems, and infant mortality."

Dr. Marc Siegel, a senior medical analyst at Planet Chronicle, stated that these advancements could potentially be incorporated into the CDC's new program, DOXY PEP, which aims to prevent chlamydia, gonorrhea, and syphilis post-exposure prophylaxis with doxycycline.

"When transmitted during pregnancy, [syphilis] can cause miscarriage, lifelong medical issues and infant death."

New York-based Siegel stated that the program has been proven to significantly reduce clinical infections.

The new syphilis test is "especially important," as "the earlier syphilis exposure/diagnosis is made, the better," according to Siegel.

The acting director of the FDA's Center for Devices and Radiological Health, Michelle Tarver, M.D., PhD, stated that advancements in STIs testing can provide patients with more information about their health from the comfort of their own homes.

"Home tests for syphilis may increase initial screening, especially among individuals who are hesitant to discuss possible exposure with their healthcare provider," she stated.

To confirm the diagnosis, Tarver suggested increasing lab testing, which can increase treatment and help prevent the spread.

As syphilis cases increase, it's disheartening to see so many advanced cases of a disease that can be easily treated.

Early detection and treatment intervention are crucial for achieving the best health outcome and reducing the overall cost burden on society, as advanced disease and disability are expensive, she emphasized.

Potential limitations

Saphier expressed reservations about the reliability of at-home illness tests, as they are typically less accurate than laboratory-based testing.

False negative results may lead to a person not seeking treatment despite needing it, as she pointed out.

"If someone is at high risk for syphilis exposure or has symptoms, they should not use at-home testing and instead consult their doctor."

The FDA stated that false negative results may occur, potentially leading to treatment delays.

The FDA advised against making any treatment decisions based solely on test results, emphasizing the need for a healthcare provider's input.

"If someone is [at] high risk for syphilis exposure or having symptoms, they should skip the at-home testing and speak to their doctor."

"Individuals who have recently been exposed to syphilis should seek care from a healthcare provider for treatment and evaluation, regardless of the test results."

According to Mayo Clinic, congenital syphilis presents with symptoms such as skin sores and rashes, fever, jaundice, runny nose or sneezing, and enlarged spleen and liver.

Untreated, later symptoms may include hearing loss, dental issues, and a "saddle nose" condition where the bridge of the nose collapses.