Collection of Capillary Fingerstick Blood, Venous Serum, and Venous K2EDTA Blood Samples From Subjects Receiving Clozapine Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 153
- 试验地点
- 1
- 主要终点
- Sample Analysis - Method Comparision
研究概览
简要总结
The method comparison study involves capillary fingerstick blood, venous serum, and venous K2EDTA blood sample collection from human subjects receiving clozapine treatment and their clozapine concentration measurement using a validated mass spectrometry method, the automated immunoassay MyCare Psychiatry Clozapine Assay Kit manufactured by SBI, and the point of care MyCare Insite Clozapine Test manufactured by SBI. Clozapine measurements obtained using the MyCare Insite Clozapine Test are intended for investigational purposes only and shall not be used in the management of patients receiving clozapine therapy.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Study subjects must meet all the following criteria to be eligible for enrollment into the study:
- •Female or male subjects 21 years of age or older;
- •Current treatment with clozapine with documentation of diagnosed psychiatric condition requiring treatment;
- •Capable of understanding and complying with parameters as outlined in the protocol;
- •Capable of understanding and providing written informed consent, approved by an Institutional Review Board (IRB) prior to the initiation of any screening or study specific procedures.
排除标准
- •Female or male subjects under the 21 years of age;
- •Unwilling or unable to follow protocol requirements or to give written informed consent.
结局指标
主要结局
Sample Analysis - Method Comparision
时间窗: October, 2022
Determine if the MyCare Insite Clozapine Test returns blood level results which are equivalent to results obtained using the MyCare Pyschiatry Assay Kit and LC-MS
次要结局
未报告次要终点