NCT05681156已完成不适用
Curian S. Pneumo/Legionella Assay Beta Clinical Trial Protocol
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 199
- 试验地点
- 1
- 主要终点
- Agreement between Curian S. pneumo/Legionella Assay and two cleared FDA assays
研究概览
简要总结
Beta trial to evaluate the preliminary clinical performance of the Curian S. pneumo/Legionella assay for its use in the qualitative detection of Streptococcus pneumoniae and/or Legionella pneumophila serogroup 1 antigens in human urine specimens.
详细描述
This study will evaluate the preliminary clinical performance of the RUO Curian S. pneumo/Legionella assay against two FDA cleared comparators for its use in the qualitative detection of Streptococcus pneumoniae and/or Legionella pneumophila serogroup 1 antigens in human urine specimens.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult males and females, with symptom of pneumonia and for whom a Streptococcus pneumoniae and/or Legionella pneumophila serogroup 1 diagnostic test has been ordered by a practicing physician.
- •At least 2mL of urine from fresh de-identified clinical specimen from standard of care lab testing
- •Only one (1) specimen per patient will be included in the study
- •Materials used within their expiration date
- •Storage time and conditions within requested indications listed on RUO Package Insert
排除标准
- •Specimens from patients for whom a Streptococcus pneumoniae and/or Legionella pneumophila serogroup 1 diagnostic test has not been ordered
- •Storage times and conditions that exceed these study protocol requirements listed on RUO Package Insert
- •Urine samples provided in unsatisfactory conditions
结局指标
主要结局
Agreement between Curian S. pneumo/Legionella Assay and two cleared FDA assays
时间窗: 7 months
Curian S. pneumo/Legionella Assay will be compared to the comparator assays (both FDA cleared)
次要结局
未报告次要终点
研究者
研究点 (1)
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