One-Step Syphilis Point of Care Test for Rapid Immunoassay Screening of Antibodies to Treponema Pallidum
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Identify the sensitivity and specificity of the POC test versus accepted laboratory tests
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and Women will be eligible who:
- •are 18 years of age or older;
- •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.
- •Pregnant women in the first and third trimester
排除标准
- •are under 18 years of age
- •unwillingness to give consent
结局指标
主要结局
Identify the sensitivity and specificity of the POC test versus accepted laboratory tests
时间窗: end of study
次要结局
- Percent positive agreement data will include supplemental test results identified by infection categories and treatment as possible(end of study)