NCT01427023已完成不适用
Prospective Collection of Female First-catch Urine, Vaginal Swab, Endocervical Swab, and Cervical Specimens for Testing With the APTIMA Trichomonas Vaginalis Assay
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 532
- 试验地点
- 7
- 主要终点
- Negative Percent Agreement Using the TIGRIS Instrument as a Reference.
研究概览
简要总结
The objective of this study is to obtain female first-catch urine, vaginal swab, endocervical swab, and cervical specimens collected in PreservCyt Solution ("PreservCyt Specimens") for testing with the APTIMA Trichomonas vaginalis (ATV) Assay.
These specimens will be used to demonstrate assay performance on the PANTHER System is comparable to performance on the TIGRIS System.
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
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Subject must be female and attend a participating clinic
- •Subject must be at least 14 years of age at the time of enrollment and is currently sexually active (has had vaginal intercourse within the past 12 months)
- •The subject and/or legally authorized representative is willing to undergo the informed consent process prior to study participation (a minor will need the documented consent of her parent or legal guardian, unless the site has an institutional review board (IRB)- approved waiver for parental consent for minors)
- •In addition, the subject must meet at least one of the following criteria:
- •Subject must demonstrate symptoms consistent with a suspected STD such as vaginal odor, vaginal discharge, vaginal/vulvar itching or irritation, pain/discomfort during sexual intercourse or urination, and/or lower abdominal discomfort
- •Subject must be asymptomatic and known to be partners with, or a contact of, a person with a confirmed or suspected STD(s)
- •Subject must be asymptomatic and undergoing screening evaluation for possible STDs
- •Subject must be undergoing Pap screening
排除标准
- •Subject took antibiotic medications within the last 14 days
- •Subject already participated in the study
- •Subject has a history of illness that the principal investigator (PI) or designee considers could interfere with or affect the conduct, results, and/or completion of the clinical trial
- •Subject has a history of illness that the PI or designee considers could create an unacceptable risk to the subject if enrolled
结局指标
主要结局
Negative Percent Agreement Using the TIGRIS Instrument as a Reference.
时间窗: approximately one year
Negative Percent Agreement Using the TIGRIS Instrument as a Reference.
Positive Percent Agreement Using the TIGRIS Instrument as a Reference.
时间窗: approximately one year
Positive Percent Agreement Using the TIGRIS Instrument as a Reference.
次要结局
- Positivity Rate(approximately one year)
研究者
研究点 (7)
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