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.
Study Type
OBSERVATIONAL
Enrollment
400
Rapid membrane test for syphilis antibodies
Johns Hopkins University
Baltimore, Maryland, United States
Identify the sensitivity and specificity of the POC test versus accepted laboratory tests
Time frame: end of study
Percent positive agreement data will include supplemental test results identified by infection categories and treatment as possible
Time frame: end of study
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