NCT02566447已完成不适用
"Solana™ Trichomonas Assay Field Study"
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 750
- 试验地点
- 4
- 主要终点
- Trichomonas Test Result
研究概览
简要总结
The Solana® Trichomonas Assay is an in vitro qualitative nucleic acid amplification test for the detection of Trichomonas vaginalis to aid in the diagnosis of trichomoniasis using the Helicase-Dependent Amplification (HDA) technology and the Solana instrument.
详细描述
This study is to establish the clinical performance of the Solana® Trichomonas Assay for the detection of Trichomonas vaginalis in vaginal swabs and urine samples as compared to a combined reference method of direct wet mount microscopy and a FDA-cleared device.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female subjects will be recruited from the general population as they present to the clinical facility. Subjects will be categorized by the clinician as either asymptomatic or symptomatic for Trichomonas vaginalis infection.
- •Symptoms in women can include:
- •Greenish-yellow, frothy vaginal discharge with a strong odor
- •Painful urination
- •Vaginal itching and irritation
- •Discomfort during intercourse
- •Lower abdominal pain (rare)
排除标准
- •The study is limited to females. Male subjects are not accepted.
- •At clinical sites informed consent, unable to understand and consent to participation; for minors this includes parent or legal guardian.
结局指标
主要结局
Trichomonas Test Result
时间窗: 2 days
Testing results will be received by testing site for current FDA cleared tests
次要结局
未报告次要终点
研究者
研究点 (4)
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