Screening for Syphilis Infections Clinical Trial
Official title:
One-Step Syphilis Point of Care Test for Rapid Immunoassay Screening of Antibodies to Treponema Pallidum
The study is designed to evaluate the performance of a rapid membrane test in a clinic or doctor's office setting to identify potential patients infected with syphilis and compare the results to currently licensed laboratory based tests.
The overall objectives of this study are to determine the performance characteristics of a candidate rapid point-of-care test (Syph-Check cassette format) for Treponema pallidum antibodies in serum, plasma and finger stick whole blood obtained from females and males attending sexually transmitted diseases (STD) clinics, family planning / reproductive health clinics, and physician's office; and to compare the performance of this new, rapid test to currently licensed laboratory based tests, the non-treponemal RPR and a Treponemal ELISA or TPPA test. ;
Observational Model: Case Control, Time Perspective: Prospective