Clinical Evaluation of the APTIMA® HPV Assay Using the PANTHER™ System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11,816
- 试验地点
- 3
- 主要终点
- HPV Assay result Agreement between TIGRIS and PANTHER Systems
研究概览
简要总结
The objective is to establish that APTIMA HPV Assay performance on the PANTHER System is comparable to performance on the TIGRIS System.
详细描述
The APTIMA HPV Assay is an in vitro nucleic acid amplification test for the qualitative detection of E6/E7 viral messenger RNA (mRNA) from 14 high-risk types of human papillomavirus (HPV) in cervical specimens. The high-risk HPV types detected by the assay include: 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68. The APTIMA HPV Assay does not discriminate between the 14 high-risk types. Cervical specimens collected in ThinPrep Pap Test vials containing PreservCyt® Solution with commercially available collection devices (broom-type device or cytobrush/spatula combination) may be tested with the APTIMA HPV Assay either pre- or post-Pap processing. The assay is used with the TIGRIS System and the PANTHER System.
The objective is to establish that APTIMA HPV 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
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •the sample had an aliquot with a valid positive or negative APTIMA HPV Assay TIGRIS System result (from testing under protocol 2007HPVASCUS30)
- •an aliquot is available and suitable for testing, and
- •the sample was randomly selected for inclusion.
排除标准
- •sample integrity was compromised (eg, stored under unacceptable conditions)
结局指标
主要结局
HPV Assay result Agreement between TIGRIS and PANTHER Systems
时间窗: 1 month
Percent Positive Agreement: The number of samples with a positive HPV Assay result on TIGRIS and PANTHER divided by the number of samples with a positive HPV Assay result on TIGRIS, multiplied by 100 Percent Negative Agreement: The number of samples with a negative HPV Assay result on TIGRIS and PANTHER divided by the number of samples with a negative HPV Assay result on TIGRIS, multiplied by 100
次要结局
未报告次要终点