Clinical development and performance of the First to Know Syphilis Self-Test for over-the-counter usage: a <i>de novo</i> rapid test for treponemal antibody

The resurgence of syphilis in the USA and globally underscores the urgent need for rapid, accessible testing. The First To Know Syphilis Test, as the first at-home, over-the-counter (OTC) test for syphilis, represents a significant breakthrough in rapid diagnostics for increased access to testing and support early diagnosis and treatment. The FTK test demonstrated excellent overall clinical performance, with 93.4% sensitivity and 99.5% specificity, confirming its reliability for syphilis detection. This novel, easy-to-use OTC syphilis test allows individuals to privately test at home and can promote testing among those hesitant or unable to seek traditional healthcare, reducing barriers like stigma and limited access. The availability of this OTC test will have a significant impact on syphilis detection and prevention strategies and reduction of comorbidities such as HIV.