NCT07260799进行中（未招募）不适用
Clinical Performance of Capillary Blood Samples Collected Using the Tasso+ Serum Gel Capillary Blood Collection System for Clinical Chemistry Testing of 14 Analytes on an Abbott Alinity Analyzer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Tasso Inc.
- 入组人数
- 150
- 试验地点
- 3
- 主要终点
- Number participants for which there is statistical equivalence between serum biomarker results obtained from capillary blood vs. venous blood
研究概览
简要总结
The purpose of this single-visit study is to demonstrate the performance of capillary blood samples collected with the Tasso+ Serum Gel Capillary Blood Collection System compared to venous reference samples for downstream analyte testing at a clinical laboratory.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 18-85 years with no previous experience with the Tasso+ lancet
- •Willing and able to provide written informed consent prior to study entry
- •Willing and able to adhere to study assessments, schedule, prohibitions and restrictions as described in the protocol
- •Healthy individuals or patients with abnormal analyte values (verified or likely to be) within intended clinical reference ranges as indicated by standard of care testing and/or past medical history, in the judgement of the investigator
排除标准
- •Present with abnormal skin integrity or atypical skin health near/on arm collection sites
- •Mental or physical impairment which would preclude participation in the judgement of the investigator or qualified designee
- •Trained clinical laboratory and healthcare personnel who have worked in the field in the previous 5 years
- •Any condition which, in the opinion of the investigator or delegate, makes the participant unsuitable for this study (including, but not limited to, any mental or physical impairment which would preclude provision of adequate and knowledgeable consent)
结局指标
主要结局
Number participants for which there is statistical equivalence between serum biomarker results obtained from capillary blood vs. venous blood
时间窗: 48 Hours
次要结局
未报告次要终点
研究者
研究点 (3)
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