Screening for Syphilis Infections
Conditions
Keywords
syphilis
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.
Interventions
DEVICESyph-Check POC
Rapid membrane test for syphilis antibodies
Sponsors
Healthcare Providers Direct, Inc.
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Identify the sensitivity and specificity of the POC test versus accepted laboratory tests | end of study |
Secondary
| Measure | Time frame |
|---|---|
| Percent positive agreement data will include supplemental test results identified by infection categories and treatment as possible | end of study |
Countries
United States
Outcome results
None listed