Retrospective Evaluation of Diagnostic Specificity and Sensitivity for iStatis Syphilis Ab Test at the Point-Of-Care Sites
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,500
- 试验地点
- 1
- 主要终点
- Sensitivity and specificity of the iStatis Syphilis Ab Test
研究概览
简要总结
The purpose of this retrospective clinical trial is to establish the clinical performance of the iStatis Syphilis AbTest. The data will be used to demonstrate the product is safe and effective for its intended use. The data obtained will be used in the application for CE certification under In Vitro Diagnostic Medical Device Regulation (IVDR) and World Health Organization (WHO) prequalification.
详细描述
The objectives of this study are to establish the diagnostic sensitivity and diagnostic specificity of the iStatis Syphilis Ab Test. Left-over samples stored at -80ᵒC from the previous trials conducted by Epicentre will be used for this study. The samples are tested in a routine testing environment. Serum samples were tested for evidence of syphilis infection using a non-treponemal Rapid Plasma Reagin (RPR) assay. All reactive samples were further tested quantitatively.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Anti-Tp negative samples:
- •Stored at ≤ -80°C.
- •Anti-Tp negative samples - pregnant women:
- •Samples from pregnant women, 1st and multipara
- •Samples found negative or false reactive for anti-Tp assay with the reference method.
- •Stored at ≤ -80°C.
- •Anti-Tp positive samples:
- •Samples screened with Abbott Architect Syphilis Tp and confirmed positive with BD Macro-Vue Particle Agglutination (RPR) and Serodia Particle Agglutination (TPPA).
- •Stored at ≤ -80°C.
- •Anti-Tp positive samples - pregnant women:
- •Samples from pregnant women
- •Samples screened with Abbott Architect Syphilis Tp and confirmed positive with BD Macro-Vue Particle Agglutination (RPR) and Serodia Particle Agglutination (TPPA).
- •Stored at ≤ -80°C.
排除标准
- 未提供
结局指标
主要结局
Sensitivity and specificity of the iStatis Syphilis Ab Test
时间窗: 8 weeks
To estimate the diagnostic specificity and diagnostic sensitivity of the iStatis Syphilis Antibody Test in detecting anti-Tp in plasma and serum
次要结局
未报告次要终点