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

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ClinicalTrials.gov Identifier: NCT00732355
Recruitment Status : Terminated (insufficient patient populations)
First Posted : August 12, 2008
Last Update Posted : March 2, 2016
Sponsor:
Information provided by (Responsible Party):
Healthcare Providers Direct, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment
Screening for Syphilis Infections Device: Syph-Check POC

Detailed Description:
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
Actual Enrollment : 400 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: One-Step Syphilis Point of Care Test for Rapid Immunoassay Screening of Antibodies to Treponema Pallidum
Study Start Date : March 2009
Actual Primary Completion Date : February 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Syphilis
U.S. FDA Resources

Group/Cohort Intervention/treatment
I
known syphilis infected patients
Device: Syph-Check POC
Rapid membrane test for syphilis antibodies
Other Names:
  • RPR
  • TPPA
  • syphilis
U
presumed uninfected patients
Device: Syph-Check POC
Rapid membrane test for syphilis antibodies
Other Names:
  • RPR
  • TPPA
  • syphilis



Primary Outcome Measures :
  1. Identify the sensitivity and specificity of the POC test versus accepted laboratory tests [ Time Frame: end of study ]

Secondary Outcome Measures :
  1. 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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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00732355


Locations
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
Healthcare Providers Direct, Inc.
Investigators
Study Director: Gary L Lehnus, Ph.D. Lehnus & Associates Consulting

Responsible Party: Healthcare Providers Direct, Inc.
ClinicalTrials.gov Identifier: NCT00732355     History of Changes
Other Study ID Numbers: SY-101
First Posted: August 12, 2008    Key Record Dates
Last Update Posted: March 2, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Healthcare Providers Direct, Inc.:
syphilis

Additional relevant MeSH terms:
Syphilis
Treponemal Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Sexually Transmitted Diseases, Bacterial
Spirochaetales Infections
Sexually Transmitted Diseases
Infection
Genital Diseases, Male
Genital Diseases, Female
Antibodies
Immunoglobulins
Immunologic Factors
Physiological Effects of Drugs