By Melinda Young
The increasing cases of syphilis, congenital syphilis, and some other sexually transmitted infections (STIs) in the post-pandemic era suggest clinicians and public health departments need additional strategies and tools to combat the problem.
Syphilis cases in the United States increased by 80% between 2018 and 2022, climbing from 115,000 cases to more than 207,000 cases. The sharp increase followed a decades-long upward trend, according to the U.S. Food and Drug Administration (FDA).1
Making people aware of self-testing is one way to reduce the spread of STIs and get people into treatment more quickly. Advantages to self-testing include convenience, better access for people who live in places lacking in OB/GYNs and/or public health departments, and privacy. Self-testing eliminates stigma for those who are concerned about their risk factors for STIs but are hesitant to mention their concerns to medical professionals during routine visits.
NOWDiagnostics recently began marketing a new self-test for syphilis, called the First To Know Syphilis Test. The test, which is the first home antibody test for syphilis, was approved on Aug. 16, 2024, for marketing by the FDA. The test can be taken at home to detect Treponema pallidum antibodies in human blood. The results are not sufficient to diagnose syphilis infection, but they can inform people that they need to see a physician for additional testing and — if needed — treatment.1
“The more diagnoses we have, the ease of doing it, the better we can get control of syphilis infections,” says Amesh Adalja, MD, a senior scholar at Johns Hopkins Center for Health Security of Baltimore, MD, and an infectious disease physician in Pittsburgh, PA.
“I’ve been a strong advocate for self-administered disease tests for a long time,” he says. “It empowers patients to figure out their status, especially with STIs where there is so much stigma around it that they may not want to tell their provider they want to be tested.”
Providers sometimes do a poor job of asking patients about their sexual health and sexual history and do not ask them to be tested for syphilis or other STIs. “Making it easier to test for syphilis is only going to increase diagnosis rates,” Adalja notes.
Although there are no available vaccines for syphilis, an easily accessible self-test can be used as a screening tool, says Alison Footman, PhD, MPH, senior program manager of sexually transmitted infections at AVAC, a human immunodeficiency virus (HIV) advocacy organization in New York. “It costs $30 in the U.S., and it just hit the shelves a few weeks ago,” she says.
“It’s over-the-counter and more of a screening tool that you buy and take the test and get results within 15 to 30 minutes,” Footman explains. “It detects antibodies and doesn’t tell you if it’s a past infection or a new infection, but it alerts you about whether you should talk to a healthcare provider about the results you’re seeing. It’s incredibly exciting.”
The syphilis self-test’s manufacturer has partnered with community-based organizations (CBOs) to provide the test, and it also is on major pharmacy chain shelves, including CVS and Walgreens, she says.
One California CBO has looked forward to the syphilis self-test approval for a couple of years and now offers it for free to some people across the United States. Building Healthy Online Communities has worked with the National Association of State and Territorial AIDS Directors (NASTAD) across the country since 2020. The organization developed a self-testing platform with 25-30 health departments to help people overcome barriers to testing for HIV and STIs, says Jen Hecht, MPH, director of Building Healthy Online Communities and executive director for Springboard HealthLab in Richmond, CA.
“If there are new technologies that become available, we’re interested in using them for participants who use the program,” Hecht says. “We’ve been in communication with NOWDiagnostics for a couple of years, knowing they were working toward FDA approval.”
Once the First To Know Syphilis Test was approved by the FDA, it was a good fit for the organization’s platform, called TakeMeHome.org. The online platform already provides people with access to the OraQuick In-Home HIV Test and self-collection kits for chlamydia and gonorrhea testing. The new syphilis self-tests became available at the beginning of 2025. “We can also do [self-collection] testing for syphilis and hepatitis C,” Hecht says.
One of the positive attributes of the syphilis self-test is that it is simple to use. Once a person has the test, they can use it in the privacy of their home and do not need to send it to a lab. If the test suggests a possible syphilis infection, the person can schedule an appointment at their primary care provider or the local health department for follow-up testing for a diagnosis and for treatment.
“It helps overcome the many barriers to in-person testing — be that cost or perceived cost, transportation, not having a primary care provider, and many other barriers,” Hecht explains. “One of our primary goals is to increase access to testing and to empower people to access testing more easily,” she adds.
The TakeMeHome.org platform does not provide free tests to everyone, but people can check the website to see if they live in a zip code where the free service is available. There are some areas from coast to coast that are covered.
People also could check with their local health department to see if the test is available at no or low cost. Providers could mention the test but also could encourage people to receive the diagnostic syphilis test if they have been engaged in sexual activity.
“It’s important for clinicians to stick to the traditional syphilis test and talk with patients about their [sexual] history because they can give them more specific information that informs treatment,” Footman says.
Self-testing gives patients additional opportunities to learn more about their health status before they see a provider. “Access to home tests can help increase initial screening for syphilis, including in individuals who may be reluctant to see their healthcare provider about possible sexually transmitted infection exposure,” says Michelle Tarver, MD, PhD, then acting director of the FDA’s Center for Devices and Radiological Health in an announcement published on Aug. 16, 2024.1
“Especially with STI tests, there is a lot of stigma, and it can be hard to find a provider to get tested and have conversations,” Footman says. “First to Know Test provides a middle ground. You go to the pharmacy, pick it up, and if it’s positive, you can talk with your healthcare provider about the results.”
Even with negative results, because the test can have false-negative and false-positive results, people can talk with their healthcare provider and express any additional concerns they may have, she adds. “It’s very accurate as a screening tool,” Footman notes. “If it’s positive, it’s likely to be a positive, but you still have to get confirmation testing.”
The U.S. Department of Health and Human Services has addressed the surging cases of syphilis and congenital syphilis by establishing the National Syphilis and Congenital Syphilis Syndemic Federal Task Force. They have created an action plan, called the STI National Strategic Plan, to reverse the rise of STIs in the United States.1
“In a situation where we have increased rates of congenital syphilis, that tells you the current system is failing, and using home testing is a way to augment what’s being done in terms of testing for the bacteria,” Adalja says. “It may not be a panacea; people still have to be aware this test exists and where to obtain it, but it does remove one major barrier if people start to use it.”
At-home testing is very convenient, especially for people who would have to travel a long distance to obtain STI screening in their own communities. “This is a way for physicians to extend their reach,” Adalja says.
The key is for physicians to let their patients know about the test and where people can purchase it. “Being able to do this in the convenience of your home has a great advantage,” he says.
Reference
1. FDA News Release. FDA marketing authorization enables increased access to first step of syphilis diagnosis. U.S. Food and Drug Administration. Aug. 16, 2024. https://www.fda.gov/news-events/press-announcements/fda-marketing-authorization-enables-increased-access-first-step-syphilis-diagnosis
The increasing cases of syphilis, congenital syphilis, and some other sexually transmitted infections (STIs) in the post-pandemic era suggest clinicians and public health departments need additional strategies and tools to combat the problem.
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