A Multi-site Clinical Evaluation of Capillary Blood Samples Collected Using the Tasso+SST Device for Downstream Analyte Testing.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Tasso Inc.
- 入组人数
- 443
- 试验地点
- 1
- 主要终点
- Number participants for which there is statistical concordance between serum biomarker results obtained from capillary blood vs. venous blood
研究概览
简要总结
This is a prospective, multi-center study within the U.S. Study participants will take part in two study visits a minimum of 14 days apart. During each visit, participants will self-collect capillary blood samples. Additionally, a healthcare provide will obtain capillary and venous serum samples. All capillary samples will be collected from the upper arm using the Tasso+ device paired with a commercially-available serum separator gel microtainer. The samples will be shipped to a clinical laboratory and tested for various analytes. Expected analyte values for each participant will be based on their venous sample results which will be compared to Tasso sample results
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
- 否
入选标准
- •Adults aged 18 - 85 years
- •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 analyte values (verified or likely to be) within intended clinical reference ranges as indicated by standard of care testing and/or past medical history (which may be documented or self-reported)
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
- •Laboratory and healthcare personnel.
- •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 concordance between serum biomarker results obtained from capillary blood vs. venous blood
时间窗: 2 Weeks
To establish the clinical performance of the Tasso+SST device for lay user self-collection and for trained healthcare provider (HCP) collection of capillary blood samples for downstream analyte testing at a clinical laboratory.
次要结局
- Number of observed device usability issues observed in lay users and HCP populations, i.e., deviations from the instructions for use.(2 Weeks)
- Number participants for which there is statistical concordance between serum biomarker results obtained from Tasso+ capillary blood by the same lay user(2 Weeks)
- Number of lay users in a simulated home setting for with statistical concordance between serum biomarker results obtained from capillary blood vs. venous blood(1 Day)
- Number participants for which there is statistical concordance between serum biomarker results obtained from Tasso+ capillary blood by two different HCPs(2 weeks)