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

Screening for Syphilis Infections Clinical Trial

— SyphPoc  

Official title:

One-Step Syphilis Point of Care Test for Rapid Immunoassay Screening of Antibodies to Treponema Pallidum

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00732355
• Other study ID #: SY-101
• Status: Terminated
• Phase: N/A
• First received: August 8, 2008
• Last updated: February 29, 2016
• Start date: March 2009
• Est. completion date: September 2010

Study information

• Verified date: February 2016
• Source: Healthcare Providers Direct, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 400
• Est. completion date: September 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Screening for Syphilis Infections
• Syphilis

Intervention

Device:
• Syph-Check POC
Rapid membrane test for syphilis antibodies

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Healthcare Providers Direct, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identify the sensitivity and specificity of the POC test versus accepted laboratory tests		end of study	No
Secondary	Percent positive agreement data will include supplemental test results identified by infection categories and treatment as possible		end of study	No