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

February 29, 2016 updated by: Healthcare Providers Direct, Inc.

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Enrollment (Actual)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Johns Hopkins University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Identify the sensitivity and specificity of the POC test versus accepted laboratory tests
Time Frame: end of study
end of study

Secondary Outcome Measures

Outcome Measure
Time Frame
Percent positive agreement data will include supplemental test results identified by infection categories and treatment as possible
Time Frame: end of study
end of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Healthcare Providers Direct, Inc.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (ACTUAL)

February 1, 2010

Study Completion (ACTUAL)

September 1, 2010

Study Registration Dates

First Submitted

August 8, 2008

First Submitted That Met QC Criteria

August 11, 2008

First Posted (ESTIMATE)

August 12, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

March 2, 2016

Last Update Submitted That Met QC Criteria

February 29, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SY-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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