Comparative Evaluation of the FINDERTM Instrument and FINDERTM G6PD Cartridge in Adults and Neonates
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 119
- 试验地点
- 3
- 主要终点
- G6PD enzymatic activity in adults and neonates
研究概览
简要总结
A prospective clinical study to compare the clinical performance of the FINDER™ Instrument and the G6PD assay to an FDA cleared instrument/reagent combination in adult and neonate populations.
详细描述
A prospective clinical study to compare the clinical performance of the FINDER™ Instrument and the G6PD assay to an FDA cleared instrument/reagent combination in adult and neonate populations. Neonate and adult subjects will be recruited from 3 clinical sites. Neonate samples will be collected as heel prick unless an in dwelling line is already in place at which point a venous or arterial/umbilical sample will be collected. Adult samples will be collected as venous/arterial samples and finger stick samples. Samples will be tested at the point of care/near patient and in the clinical laboratory using the FINDER Instrument and G6PD assay on a digital microfluidic platform. Samples will also be sent to a third party CLIA laboratory for test using an FDA 510(k) cleared instrument/reagent combination for G6PD.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 35 Weeks 至 100 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Neonates aged >35 gestational weeks or older.
- •Adult subjects who are age 18 and older.
- •Adult subjects who weigh at least 110 pounds.
- •All ethnicities.
- •Male and female subjects.
排除标准
- •Adult subjects who weigh less than 110 pounds.
- •Subjects with anemia for which an attending physician will not authorize a blood draw.
- •Subjects who have received a blood transfusion.
- •Subjects who are pregnant.
结局指标
主要结局
G6PD enzymatic activity in adults and neonates
时间窗: Immediately following a blood draw.
G6PD enzymatic activity in the FINDER System for adults and neonates compared to the G6PD activity tested using a known FDA cleared assay/instrument combination
次要结局
- Point of care/near patient results and clinical laboratory results(Immediately following a blood draw.)
- Arterial/venous whole blood results and tissue capillary test results(Immediately following a blood draw.)