Comparison of PSP Values Measured With Venous Whole Blood and Those Measured With Arterial Whole Blood.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Abionic SA
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Primary assessment
研究概览
简要总结
Abionic has developed a targeted, rapid test for pancreatic stone protein (PSP) in human K2-EDTA venous whole blood using the abioSCOPE instrument.
Currently no PSP study comparaison has been done between venous and arterial whole blood. Abionic would like to confirm the equivalence of the PSP between venous whole blood and arterial whole blood.
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
- 是
入选标准
- •Provide signed and dated written informed consent by patient or close / family / trusted person prior to any mandatory study-specific procedures, sample collection, or analysis;
- •Male or female, 18 years of age or older;
- •Patient admitted to hospital
- •Need for venous and arterial blood samples as part of standard of care
- •Covered by a social security scheme.
排除标准
- •Subject suffering from a hematological pathology (coagulation disorder, severe anemia) that could interfere with the blood draw procedure;
- •Subject under juridical protection.
结局指标
主要结局
Primary assessment
时间窗: through study completion, an average of 1.5 months
Pairwise comparability of test results when performed with K2-EDTA anticoagulated venous whole blood or K2-EDTA anticoagulated arterial whole blood, represented as percent recovery of arterial whole blood compared to venous whole blood, as well as scatter plots with Weighted Deming and Passing Bablok Regression, and bias plots.
次要结局
未报告次要终点