A Validation Study of Genzyme Diagnostics OSOM Trichomonas Rapid Test and BVBlue Test
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 519
- 试验地点
- 1
- 主要终点
- Sensitivity of the OSOM Rapid Test and PCR Wet Mount Microscopy in Diagnosing Trichomonas Vaginalis in Symptomatic and Asymptomatic Women
研究概览
简要总结
This research is being done to see if two rapid bedside tests (OSOM Trichomonas Rapid Test and BVBlue Test) that give results in 10 minutes are as accurate as standard tests to diagnose common vaginal infections.
详细描述
This research is being done to see if two rapid bedside tests (OSOM Trichomonas Rapid Test and BVBlue Test) that give results in 10 minutes are as accurate as standard tests (that take up to 7 days to get results) to diagnose common vaginal infections (Trichomonas and bacterial vaginosis).
Both rapid tests (OSOM and BVBlue) are approved by the Food and Drug Administration (FDA) to be used by healthcare professionals to aid in the diagnosis of these infections. This study is being done to validate (or confirm)the accuracy of these tests. This study may help researchers decide if these tests could be used in remote research settings (in place of the standard office testing) to increase diagnosis and prompt treatment of these vaginal infections.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •At least 15 years of age at time of enrollment
- •Ability to provide written informed consent
排除标准
- •Currently menstruating or bleeding
- •Use of an antibiotic to treat bacterial vaginosis or Trichomonas within the past 7 days
结局指标
主要结局
Sensitivity of the OSOM Rapid Test and PCR Wet Mount Microscopy in Diagnosing Trichomonas Vaginalis in Symptomatic and Asymptomatic Women
时间窗: Visit 1
Sensitivity of the OSOM Rapid test and PCR wet mount microscopy in diagnosing Trichomonas vaginalis using Trichomonas culture as the gold standard in symptomatic and asymptomatic women. The sensitivity of a test is the percentage of people who have the infection (as diagnosed by the gold standard method) among those who have a positive test.
次要结局
- Specificity of the OSOM Rapid Test and PCR Wet Mount Microscopy in Diagnosing Trichomonas Vaginalis in Symptomatic and Asymptomatic Women(Visit 1)
- Sensitivity of the BVBlue Test and Amsel Criteria in Diagnosing Bacterial Vaginosis in Symptomatic and Asymptomatic Women.(Visit 1)
- Specificity of the BVBlue Test and Amsel Criteria in Diagnosing BV in Symptomatic and Asymptomatic Women.(Visit 1)
研究者
Sharon Hillier
PhD
University of Pittsburgh