NCT02795975终止不适用
Clinical Evaluation of the Aptima® Combo 2® Assay Using the Panther® System in Female Urine Samples
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1,766
- 试验地点
- 18
- 主要终点
- Sensitivity and specificity
研究概览
简要总结
The objective of this study is to evaluate the performance characteristics of the AC2 assay on the Panther system using female urine specimens.
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
- •The subject is ≥14 years of age at the time of enrollment and is currently sexually active (eg, has had penile/vaginal intercourse within the past 6 months).
- •For subjects under 18 years old, assent of the subject and/or parental/legal guardian permission has been obtained if required by the institutional review board (IRB).
- •The subject and/or legally authorized representative is willing and able to undergo the informed consent process prior to study participation, and:
- •reports symptoms consistent with a suspected STI (eg, abnormal discharge, genital itching, pain/discomfort during sexual intercourse or urination, and/or lower abdominal discomfort); or
- •is asymptomatic and known to be partners with, or a contact of, a person with a confirmed or suspected STI; or
- •is asymptomatic and undergoing screening evaluation for possible STIs; or
- •is asymptomatic and undergoing a routine pelvic examination.
排除标准
- •The subject took antibiotic medications within the last 21 days prior to collection.
- •The subject already participated in the study.
- •The subject has a history of illness that the PI or designee considers could interfere with or affect the conduct, results, and/or completion of the study.
结局指标
主要结局
Sensitivity and specificity
时间窗: Enrollment ongoing until estimated March 2017
次要结局
未报告次要终点
研究者
研究点 (18)
Loading locations...
相似试验
已完成
不适用
Clinical Evaluation of the APTIMA® COMBO 2® Assay Using the PANTHER™ SystemChlamydia TrachomatisNeisseria Gonorrhoeae InfectionNCT01733069Gen-Probe, Incorporated1,912
已完成
不适用
A Validation Study for Detecting Chlamydia and Gonorrhea in Rectal SamplesGonorrheaChlamydiaNCT00827697University of Pittsburgh399
已完成
2 期
ACP-196 Versus Placebo in Subjects With Rheumatoid Arthritis on Background MethotrexateRheumatoid ArthritisNCT02387762Acerta Pharma BV31
已完成
不适用
APTIMA HPV 16 18/45 Genotype Assay on the TIGRIS DTS System in Women With ASC-US or Negative Pap Test ResultsHuman Papillomavirus InfectionNCT01384370Gen-Probe, Incorporated1,260
尚未招募
2 期
Apatinib and Fluzoparib With or Without Adebrelimab in Previously-treated TP53-mutant Advanced Non-small Cell Lung CancerNon-small Cell Lung CancerNSCLCNCT05932264Sun Yat-sen University60