User Testing Protocol to Evaluate Performance of the Evivo Infant Gut Bifidobacterium Screening Test
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 231
- 试验地点
- 10
- 主要终点
- To evaluate the Evivo Screening Test's ability to differentiate between high and low levels of Bifidobacterium in infant stool specimens compared to molecular methods (quantitative PCR).
研究概览
简要总结
The study is an evaluation of the Evivo Screening Test's ability to differentiate between high and low levels of Bifidobacterium in infant stool specimens.
详细描述
This is a prospective, multi-center clinical study of the Evivo Infant Gut Bifidobacterium Screening Test ("Evivo Screening Test").
Lower levels of bifidobacteria in the infant gut have been linked to increased incidence of metabolic and inflammatory disorders. This CLIA Waiver User Testing study is being conducted to evaluate the performance of the Evivo Infant Gut Bifidobacterium Screening Test, which was designed to differentiate between high and low levels of Bifidobacterium in infant stool. This study is intended to confirm the precision of results for this screening test, as well as its ease of use, in a setting that closely resembles the conditions of intended use, specifically the circumstances of sample collection, the location of test sites, and the potential operators.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- — 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Infants aged 0-6 months.
- •Generally healthy infants.
排除标准
- •Infants should not have an acute infection.
- •Not intended for use with stool containing meconium.
- •Infants with jaundice should not be tested until it has resolved.
- •This test should not be used for infants with carbohydrate malabsorption syndrome, which may present with one or more of the following persistent signs: abnormally foul-smelling, mucus-containing, and/or green frothy stools.
结局指标
主要结局
To evaluate the Evivo Screening Test's ability to differentiate between high and low levels of Bifidobacterium in infant stool specimens compared to molecular methods (quantitative PCR).
时间窗: 2 - 6 weeks
The primary objective of this CLIA Waiver User Testing study is to evaluate the performance of the Evivo Infant Gut Bifidobacterium Screening Test in a setting that closely resembles the conditions of intended use, specifically the circumstances of sample collection, the location of test sites, and the potential operators.
次要结局
- Ease of use of the Evivo Screening Test by operators.(2 - 6 weeks)