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

Terminated

• Conditions: Screening for Syphilis Infections
• Interventions: Device: Syph-Check POC

• Registration Number: NCT00732355
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2008-08-08
• Study First Submitted QC: 2008-08-11
• Study First Posted: 2008-08-12
• Study Start: 2009-03
• Primary Completion: 2010-02
• Study Completion: 2010-09
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-29
• Last Update Posted: 2016-03-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 400

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
U	Syph-Check POC	presumed uninfected patients
I	Syph-Check POC	known syphilis infected patients

Primary Outcome Measures

Name	Time	Method
Identify the sensitivity and specificity of the POC test versus accepted laboratory tests	end of study

Secondary Outcome Measures

Name	Time	Method
Percent positive agreement data will include supplemental test results identified by infection categories and treatment as possible	end of study

Trial Locations

Locations (1)

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States