Cascadion™ SM Immunosuppressants Panel, Stability of Tacrolimus, Cyclosporine A, Everolimus and Sirolimus in Whole Blood Patient Samples
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Acceptance criteria for claiming the patient samples storage stability
研究概览
简要总结
This is a prospective, observational evaluation study to assess the stability of the analytes tacrolimus, cyclosporine A, everolimus and sirolimus measured with Cascadion™ SM Immunosuppressants Panel. Study is pre-market evaluation for the regions where Cascadion™ SM Immunosuppressants Panel is not on the market yet and post-market evaluation where it is.
To assess the stability of tacrolimus, cyclosporine A, everolimus and sirolimus in patient whole blood samples after they are collected, processed and subjected to various storage conditions or freeze-thaw cycles that represent common sample handling conditions in the commercial clinical laboratory setting.
Study subjects will undergo one venous sample collection where 30 mL of blood is drawn.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •Age ≥18 years
- •Ability to sign informed consent form
- •At least one of the following
- •Kidney, liver or heart transplant patient using tacrolimus or cyclosporine A
- •Kidney or liver transplant patient using everolimus
- •Kidney transplant patient using sirolimus
排除标准
- •Inability to provide informed consent
- •Pregnancy or breastfeeding
- •Likely to believe that the sample collection procedure will pose an unusually high risk for subject's physical or mental health or their comfort
结局指标
主要结局
Acceptance criteria for claiming the patient samples storage stability
时间窗: 5 months
Stability of cyclosporine A, tacrolimus, everolimus and sirolimus in patient whole blood samples will be tested at +15-25°C up to 4 days, at +2-8°C up to 15 days and at -20±5°C up to 31 days. Relative bias at each time point to T0 baseline is calculated for each patient sample separately. The grand average relative bias across all samples, and the associated 95% confidence interval, must be within -15% and +15%.
次要结局
未报告次要终点