Clinical Evaluation of the APTIMA® COMBO 2®Assay Using the PANTHER™ System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,912
- 试验地点
- 7
- 主要终点
- APTIMA Combo 2 Assay Accuracy Compared to Infected Status by Sample Type
研究概览
简要总结
The objectives of this study are to establish the performance characteristics of the AC2 (APTIMA Combo 2) Assay on the PANTHER System for the sample types cleared for use on the TIGRIS and DTS (Direct Tube Sampling) Systems and to demonstrate the repeatability and reproducibility of the AC2 Assay on the PANTHER System.
详细描述
The results of this protocol AC2PS-US11-001 (NCT01733069) are based on samples collected from protocol ACTPS-US10-001(NCT01358799).
The registration for NCT01358799 was withdrawn because the samples were not tested under protocol ACTPS-US10-001, instead they were tested under the protocol registered here AC2PS-US11-001 (NCT01733069).
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
- All
- 接受健康志愿者
- 是
入选标准
- •The subject is at least 14 years of age at the time of informed consent and is sexually active
- •The subject reports symptoms consistent with a suspected STD (sexually transmitted disease) such as abnormal discharge, genital itching, pain/discomfort during sexual intercourse or urination, and/or lower abdominal discomfort.
- •If the subject is asymptomatic, the subject is known to be partners with, or a contact of, a person with a confirmed or suspected STD(s), is undergoing screening evaluation for a possible STD(s), and/or is scheduled for a routine exam that may include a pelvic exam
- •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 his/her parent or legal guardian, unless the site has an IRB (institutional review board) approved waiver for parental consent for minors)
排除标准
- •A potential subject will be ineligible for clinical trial enrollment if the subject, clinician, or medical record reports any of the following:
- •The subject took antibiotic medications within the last 21 days
- •The subject is underage (as defined by the IRB (institutional review board) or state law), without the documented consent of her/his parent or legal guardian (exception: sites that have an IRBapproved waiver for parental consent for minors)
- •The subject is determined by the investigator to be medically unsuitable for participation in this study (eg, medical history of concurrent illness that could result in an unacceptable risk to the subject) Concurrent participation in other clinical study(ies) may be acceptable, with approval by the investigator and sponsor.
结局指标
主要结局
APTIMA Combo 2 Assay Accuracy Compared to Infected Status by Sample Type
时间窗: Baseline
Count of participants having a positive or negative APTIMA Combo 2 assay result (sensitivity and specificity)
次要结局
未报告次要终点