NCT06111911已完成不适用
Detection of High-Risk Human Papilloma Virus in Urine and Cervical Swab Specimens; Comparison Between HPV Diagnostic Kit (Bio Farma) and COBAS 6800 HPV (Roche Molecular Systems)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- PT Bio Farma
- 入组人数
- 900
- 试验地点
- 2
- 主要终点
- Performance of HPV Diagnostic Kit (Bio Farma) using urine and cervical swab sample
研究概览
简要总结
This study is a cross-sectional study to evaluate accuracy of high-risk DNA-HPV testing using HPV Diagnostic Kit (Bio Farma) compared to Standard Kit (COBAS® 6800 HPV from Roche Molecular Systems) RT-PCR based in urine and cervical swab specimens.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Sexually active female aged 20-50 years
- •Willing to participate in study and signed the informed consent form.
排除标准
- •Pregnant women
- •History of HIV infection
- •On menstruation period
- •History of complete HPV vaccination
结局指标
主要结局
Performance of HPV Diagnostic Kit (Bio Farma) using urine and cervical swab sample
时间窗: 0 days
Sensitivity and Specificity of HPV Diagnostic Kita (Bio Farma)
次要结局
未报告次要终点
研究者
研究点 (2)
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