(PL22) DEVELOPMENT AND PERFORMANCE OF THE FIRST-TO-KNOW SYPHILIS TEST FOR OVER-THE-COUNTER USAGE IN THE GENERAL POPULATION: A DE NOVO RAPID TEST FOR TREPONEMAL ANTIBODY.

Background:
The recent outbreak of syphilis in MSM, in over 55 populations, and congenital syphilis has hastened the need for widely available Syphilis testing. Almost 60% of syphilis infections are asymptomatic, although almost all develop antibody. Lessons from COVID-19 show people are capable of self testing and this helps direct positive cases to seek treatment. The First-To Know® Syphilis test (NOWDiagnostics. Springdale Arkansas) is under review for over-the-counter (OTC) usage in the USA,  can be administered at home, once cleared and will aid in the diagnosis of infection with Treponema pallidum.

Methods:
First to know is a simple buffer-less lateral flow device that detects antibodies to syphilis antigens and requires a fingerstick and whole blood to run the test in as little as 15 minutes. Our clinical testing included both pregnant cohorts and all comer cohorts. This is a de novo device as there is nothing else like it as an OTC test. For this study we used the algorithm of 2/3 tests had to be positive for a true positive. A positive result in First-To-Know®, without supporting testing, means you either have syphilis or have had syphilis in the past.

Results:
Results from a large multi site study included a set of enriched samples for pregnant women. sexually active and expectant mother cohort will be discussed along with overall comparator and RPR tests, as well as OTC in the general population. From 1440 clinically enrolled self-administered tests, recruits scored an overall 96.52% sensitivity and a 99.48 % specificity. A series of supportive studies and analytics are required and were completed for FDA review.

Conclusion:
Indeed, the First-To-Know® test is simple enough to be performed in any setting and availability of this test should have a dramatic impact of syphilis detection and prevention strategies and reduce comorbidities such as HIV-1 and other STI transmission.