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# At-Home Test Authorized for Syphilis
- URL: https://www.fdaweb.com/at-home-test-authorized-for-syphilis/
- Published: 2024-08-16T12:00:00.000Z
- Updated: 2026-09-14T14:38:44.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5157590

FDA has granted a de novo marketing authorization to NOWDiagnostics for its First To Know Syphilis Test, an at-home, over-the-counter test for detecting syphilis (*Treponema pallidum*) antibodies in human blood.

“Results from this type of test alone are not sufficient to diagnose syphilis infection and should be followed by additional testing to confirm a diagnosis of syphilis,” an[ FDA release](https://www.fda.gov/news-events/press-announcements/fda-marketing-authorization-enables-increased-access-first-step-syphilis-diagnosis?utm%5Fmedium=email&utm%5Fsource=govdelivery) says. It notes that the risks associated with the test are similar to most tests — the possibility of false positive and false negative results. “False negative test results can result in delays to effective treatment, progression to disseminated disease, and spread of infection to other persons throughout your community,” it says. “False positive results could lead to additional unnecessary testing and delay in receiving a correct diagnosis.”