A newly authorized at-home test for syphilis allows users to prick their finger to draw a drop of blood. Results from this test alone are not sufficient to diagnose syphilis, and more testing should be performed to confirm an infection. (Wirestock/Getty Images)
The FDA has approved the first at-home syphilis test as cases of the bacterial infection surge to a 70-year high. The test, developed by NowDiagnostics, received authorization on Friday, August 16, 2024. The test allows users to prick their finger, draw a drop of blood, and get results in 15 minutes. While this test is a significant advancement, it is not sufficient for a conclusive diagnosis. Additional testing by a healthcare provider is necessary to confirm the results.
Syphilis, nearly eradicated in the 1990s, has seen a dramatic resurgence in recent years. According to the CDC, between 2018 and 2022, syphilis cases increased by nearly 80%. The rise in cases highlights the urgent need for more accessible testing options. The new at-home test is expected to be available in pharmacies, major retail stores, and online by September. Public health officials believe it will help reduce the stigma associated with sexually transmitted infections by offering a private testing option.
However, challenges remain in ensuring the test reaches those most in need. Public health experts are concerned that the test might only be accessible to those who can afford it, leaving vulnerable populations, such as the homeless or undocumented, without adequate testing resources. The retail price of the test is set at $29.98, but NowDiagnostics plans to collaborate with federal agencies, state and local health officials to distribute the tests for free at clinics and health departments.
Syphilis is a sexually transmitted infection caused by the bacterium Treponema pallidum. It primarily spreads through direct contact with a syphilis sore during vaginal, anal, or oral sex. The infection can also be passed from a pregnant woman to her fetus, leading to congenital syphilis. The latter has seen a worrying increase, with cases rising by 183% between 2018 and 2022. In response, the Department of Health and Human Services created a task force aimed at reducing syphilis cases in newborns by 5% by next month.
Using the at-home test involves pricking a finger to draw a drop of blood. However, a positive result from this test should be confirmed with further testing by a healthcare provider. Syphilis often goes undetected because its early symptoms, such as painless ulcers, can be easily overlooked. If left untreated, syphilis can cause serious health issues, including fevers, skin rashes, and later, heart and neurological problems. Fortunately, syphilis can be treated with antibiotics, particularly penicillin, if caught early. However, a shortage of one form of penicillin, which is solely manufactured by Pfizer, has added complications to treatment efforts. Pfizer expects the supply to improve in the last three months of this year.
The recent spike in syphilis cases is attributed to several factors, including inadequate screening, insufficient funding at federal and local levels, and the impact of the COVID-19 pandemic on STI clinics. While several rapid tests are available, they must be administered by a healthcare professional. The new at-home test could significantly benefit individuals who are highly motivated and concerned about their sexual health. However, it may not be enough to address the needs of vulnerable populations who often go undiagnosed and untreated.
To address these challenges, NowDiagnostics plans to use social media and collaborate with major retailers to raise awareness about the test. They also plan to target specific groups, such as pregnant individuals and men who have sex with men, to ensure the test reaches those at higher risk. The company acknowledges that this will require substantial effort but believes that making the test available is a critical step toward controlling the spread of syphilis.
The approval of the at-home syphilis test is a significant development in the fight against sexually transmitted infections. However, public health experts caution that it is not a panacea. Ensuring that the test is accessible to all, especially the most vulnerable, will be key to its success in reducing syphilis rates across the country. The rise in syphilis cases underscores the importance of innovative strategies and accessible healthcare options in combating the resurgence of this once nearly eradicated infection.
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