T2Resistance 510(k) Study Protocol - Detection and Identification of Several Classes of Resistance Genes in Both Gram-positive and Gram-negative Pathogens
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,566
- 试验地点
- 10
- 主要终点
- Safety / Adverse Events
研究概览
简要总结
The purpose of this study is to evaluate the safety and effectiveness of the T2Resistance Panel by validating clinical performance in three study arms:
- Prospective arm: positive percent agreement (PPA) and negative percent agreement (NPA) against genetic determinants of resistance detected in whole blood clinical samples or isolates collected from positive blood cultures prospectively collected clinical samples of whole blood.
- Contrived arm: positive percent agreement (PPA) and negative percent agreement (NPA) against samples with known status, via spiking healthy whole blood samples with bacterial strains harboring the resistance gene targets on the T2Resistance Panel.
- Healthy donor arm: negative percent agreement (NPA) with presumed negativity of healthy donor whole blood samples.
The data from all arms of the study will be used to support the Premarket Notification for the T2Resistance Panel to the U.S. Food and Drug Administration.
Primary Endpoints
The primary endpoints of this study with the T2Resistance Panel are estimated sensitivity, specificity, and safety.
详细描述
The purpose of this study is to evaluate the safety and effectiveness of the T2Resistance Panel by validating clinical performance in three study arms:
- Prospective arm: positive percent agreement (PPA) and negative percent agreement (NPA) against genetic determinants of resistance detected in whole blood clinical samples or isolates collected from positive blood cultures prospectively collected clinical samples of whole blood.
- Contrived arm: positive percent agreement (PPA) and negative percent agreement (NPA) against samples with known status, via spiking healthy whole blood samples with bacterial strains harboring the resistance gene targets on the T2Resistance Panel.
- Healthy donor arm: negative percent agreement (NPA) with presumed negativity of healthy donor whole blood samples.
The data from all arms of the study will be used to support the Premarket Notification for the T2Resistance Panel to the U.S. Food and Drug Administration.
Primary Endpoints
The primary endpoints of this study with the T2Resistance Panel are estimated sensitivity, specificity, and safety.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Prospective Arm:
- •Obtain informed consent according to institutional requirements, as needed.
- •Patient has had a diagnostic blood culture ordered per routine standard of care.
- •Patient is 18 years of age or older.
排除标准
- •Prospective Arm
- •Patient has other co-morbid condition(s) that, in the opinion of the Investigator, could limit the patient's ability to participate in the study or impact the scientific integrity of the study.
- •Patient has had previous specimens tested for the T2Resistance Panel with valid results.
结局指标
主要结局
Safety / Adverse Events
时间窗: During patient blood draw or immediately after blood draw, typically <1 hour.
Potential adverse events associated with the collection of blood samples for T2Resistance Panel Testing.
Sensitivity - Prospective
时间窗: Six months from collection, maximum.
Positive concordance between positive T2Resistance panel results for positive samples.
Specificity - Prospective
时间窗: Six months from collection, maximum.
Negative concordance between a negative ("Target not Detected") result on the T2Resistance Panel and a negative sequencing result or a known negative sample.
次要结局
- Specificity - Contrived(Six months from collection, maximum.)
- Sensitivity - Contrived(Six months from collection, maximum.)