At-home STI testing has gained traction both in stores and online, yet until recently, only HIV tests had received FDA approval for home use. This is changing with the FDA’s recent authorization of an over-the-counter syphilis test.
The newly approved product, NOWDiagnostics’ First To Know Syphilis Test, represents a significant development. Syphilis, if untreated, can cause severe health issues, including fevers, rashes, and, ultimately, complications affecting the heart and brain.
The FDA’s approval, granted on August 16, is based on substantial evidence from real-world clinical trials proving the test’s accuracy. Dr. Carlos Zambrano, an infectious disease specialist at Loretto Hospital, noted that the approval reflects the test’s proven reliability.
This approval comes in response to a troubling rise in syphilis cases across the U.S. According to the Centers for Disease Control and Prevention (CDC), syphilis cases surged by 80% from 2018 to 2022, escalating from 115,000 to over 207,000. The increase in congenital syphilis, transmitted from mother to newborn, is even more alarming, with over 3,700 cases in 2022 compared to 1,300 in 2018.
To address this crisis, the Department of Health and Human Services launched the National Syphilis and Congenital Syphilis Syndemic Federal Task Force earlier this year. An FDA spokesperson confirmed that the new test aligns with the task force’s STI National Strategic Plan aimed at curbing STI rates in the U.S.
Test Mechanics
The First To Know Syphilis Test, a treponemal test, detects antibodies to Treponema pallidum, the bacterium responsible for syphilis. The process involves a simple finger prick to collect blood, with results available within 15 minutes. Although positive results indicate past exposure to syphilis, a healthcare provider must confirm active infection and prescribe antibiotics if necessary.
Dr. Edward Hook, a professor at the University of Alabama at Birmingham and advisor to the American Sexual Health Association, emphasizes that while the test is effective, it does not replace the need for professional diagnosis and treatment. Dr. Michelle Forcier from Folx Health cautions that false negatives, though rare, can occur, and that the tests should be used to enhance early detection and treatment.
NOWDiagnostics plans to release the test in late 2024, priced at $29.98.
Expansion of At-Home STI Testing
The market for at-home STI tests is expanding, with products available for various infections such as hepatitis B and trichomoniasis, though many lack FDA approval. The OraQuick InHome HIV Test, approved in 2012, was the first home STI test authorized by the FDA. More recently, in November 2023, the FDA approved the LetsGetChecked Simple 2 Test for chlamydia and gonorrhea, which requires sending samples to a lab.
At-home tests provide increased accessibility and privacy, particularly for those with barriers to clinic visits due to work, childcare, or transportation issues. Dr. Hook points out that the convenience and discretion of at-home testing can reduce stigma and encourage more frequent testing.
However, at-home tests have limitations, including lack of insurance coverage and potential inaccuracies in non-FDA approved products. Experts stress that these tests should be seen as preliminary tools, with follow-up from healthcare professionals essential for accurate diagnosis and treatment.
