Syph-Check Syphilis Antibody Point of Care (POC) Test (SyphPoc)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00732355
Recruitment Status : Terminated (insufficient patient populations)
First Posted : August 12, 2008
Last Update Posted : March 2, 2016
Information provided by (Responsible Party):
Healthcare Providers Direct, Inc.

August 8, 2008
August 12, 2008
March 2, 2016
March 2009
February 2010   (Final data collection date for primary outcome measure)
Identify the sensitivity and specificity of the POC test versus accepted laboratory tests [ Time Frame: end of study ]
Same as current
Complete list of historical versions of study NCT00732355 on Archive Site
Percent positive agreement data will include supplemental test results identified by infection categories and treatment as possible [ Time Frame: end of study ]
Same as current
Not Provided
Not Provided
Syph-Check Syphilis Antibody Point of Care (POC) Test
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
Not Provided
Not Provided
Non-Probability Sample
Point of Care clinics and doctor's office that test routine patients (both male and female), i.e. STD clinics, planned parenthood, pre-marital, blood donors, pre-employment, and general populations from different geographic locations having varying prevalence populations.
Screening for Syphilis Infections
Device: Syph-Check POC
Rapid membrane test for syphilis antibodies
Other Names:
  • RPR
  • TPPA
  • syphilis
  • I
    known syphilis infected patients
    Intervention: Device: Syph-Check POC
  • U
    presumed uninfected patients
    Intervention: Device: Syph-Check POC
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
September 2010
February 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Plan to Share IPD: No
Healthcare Providers Direct, Inc.
Healthcare Providers Direct, Inc.
Not Provided
Study Director: Gary L Lehnus, Ph.D. Lehnus & Associates Consulting
Healthcare Providers Direct, Inc.
February 2016