Expired Study
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Baltimore, Maryland 21205


Purpose:

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.


Study summary:

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.


Criteria:

Inclusion Criteria: - Men and Women will be eligible who: 1. are 18 years of age or older; 2. Routine "presumed uninfected" for screening visit, or show symptomatic signs of infection or are asymptomatic but are suspected of infection, and either/or have other STD disease conditions and infections, will be identified. 3. Pregnant women in the first and third trimester Exclusion Criteria: - are under 18 years of age - unwillingness to give consent


NCT ID:

NCT00732355


Primary Contact:

Study Director
Gary L Lehnus, Ph.D.
Lehnus & Associates Consulting


Backup Contact:

N/A


Location Contact:

Baltimore, Maryland 21205
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 23, 2018

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