A Prospective Cross-Sectional Study to Evaluate Diagnostic Sensitivity and Specificity of 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
- 2
- 主要终点
- Sensitivity and specificity of the iStatis Syphilis Ab Test
研究概览
简要总结
This study is a prospective cross-sectional study in which surgically non-invasive sample- taking is done only for the purpose of the study. Capillary (fingerstick) whole blood and plasma (i.e., obtained through venous EDTA whole blood collection and processing) are collected by a healthcare professional. The collected samples are tested in a routine testing environment, i.e., healthcare providers at
详细描述
A trained healthcare provide will collect 50μL of capillary whole blood and 11mL of EDTA venous whole blood (VWB) to be tested with the iStatis Syphilis Ab Test on site according to the 'Test Procedure' described in the Instructions for Use (IFU) supplied with the reagents. Same procedure must be followed using the extracted plasma sample to test 30μL of the plasma sample extracted and obtained through processing of the VWB on the iStatis Syphilis Ab Test. An aliquot of the plasma sample will be transferred to the central laboratory to establish the reference test result using an enzyme immunoassay (EIA) (Abbott Architect Syphilis Tp EDA). In case of positive results in the EIA reference test of (Abbott Architect Syphilis Tp EDA), the sample will be sent for BD Macro-Vue Particle Agglutination (RPR) and Serodia Particle Agglutination (TPPA) testing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Double (Participant, Care Provider)
盲法说明
Participants and the healthcare providers are not aware of the syphilis status.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants/subjects (males, females, and pregnant women) getting tested for syphilis for one or more of the following reasons:
- •o at risk for syphilis ohaving signs and symptoms indicative for syphilis oRoutine testing
- •Participants/subjects of 18 years or older and, who are able to give/sign the informed consent.
排除标准
- •Participant younger than 18 years old
- •Participants unable to provide written informed consent
- •Participants currently undergoing treatment
结局指标
主要结局
Sensitivity and specificity of the iStatis Syphilis Ab Test
时间窗: 15 weeks
To evaluate the diagnostic sensitivity and diagnostic specificity of the iStatis Syphilis Antibody Test at Point-Of-Care (POC).
次要结局
未报告次要终点