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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2008 by Healthcare Providers Direct, Inc..
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Healthcare Providers Direct, Inc.
ClinicalTrials.gov Identifier:
NCT00732355
First received: August 8, 2008
Last updated: August 11, 2008
Last verified: August 2008
History of Changes
  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.


Condition Intervention
Syphilis Serodiagnosis
 Device: Syph-Check POC

Study Type: Observational
Study Design: Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: One-Step Syphilis Point of Care Test for Rapid Immunoassay Screening of Antibodies to Treponema Pallidum

Resource links provided by NLM:

MedlinePlus related topics: Syphilis
U.S. FDA Resources

Further study details as provided by Healthcare Providers Direct, Inc.:

Primary Outcome Measures:
  • Identify the sensitivity and specificity of the POC test versus accepted laboratory tests [ Time Frame: end of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percent positive agreement data will include supplemental test results identified by infection categories and treatment as possible [ Time Frame: end of study ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: October 2008
Estimated Study Completion Date: June 2009
Estimated Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00732355

Contacts
Contact: Charlotte A Gaydos, Dr.P.H 410-614-0932 cgaydos@jhmi.edu

Locations
United States, Maryland
Johns Hopkins University Not yet recruiting
Baltimore, Maryland, United States, 21205
Contact: Charlotte A Gaydos, Dr.P.H.     410-614-0932     cgaydos@jhmi.edu    
Principal Investigator: Charlotte A Gaydos, Dr.P.H.            
Sponsors and Collaborators
Healthcare Providers Direct, Inc.
Investigators
Study Director: Gary L Lehnus, Ph.D. Lehnus & Associates Consulting
  More Information

No publications provided

Responsible Party: Norman Proulx, President
ClinicalTrials.gov Identifier: NCT00732355     History of Changes
Other Study ID Numbers: SY-101
Study First Received: August 8, 2008
Last Updated: August 11, 2008
Health Authority: United States: Institutional Review Board

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
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013