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

Healthcare Providers Direct

Status: Terminated

Conditions: Screening for Syphilis Infections

Treatments: Device: Syph-Check POC

Study type: Observational

Funder types: Industry

Identifiers

NCT00732355

SY-101

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

400 participants in 2 patient groups

I

Description:

known syphilis infected patients

Treatment:

Device: Syph-Check POC

U

Description:

presumed uninfected patients

Treatment:

Device: Syph-Check POC