临床试验/NCT05467449

NCT05467449已完成不适用

DxFLEX ClearLLab 10C US-IVD Clinical Study Protocol - Clinical Laboratory

Beckman Coulter, Inc.6 个研究点分布在 3 个国家目标入组 527 人开始时间: 2022年4月12日最近更新: 2024年2月13日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: Beckman Coulter, Inc.
入组人数: 527
试验地点: 6
主要终点: Flow immunophenotyped normal and abnormal

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

A multi-center method comparison study is designed per CLSI-EP09 A3. This study compares the qualitative immunophenotype agreement between DxFLEX and Navios EX to demonstrate the accuracy of the DxFLEX-10C system. A series of precision studies will be conducted with each focusing on different aspects of the DxFLEX-10C system.

研究设计

研究类型: Observational
观察模型: Cohort
时间视角: Prospective

入排标准

性别: All
接受健康志愿者: 否

入选标准

•Patient specimens targeted for this study will be residual samples with sufficient volume from whole blood, bone marrow, and lymph node meeting the following criteria:
•Specimens from new cases or follow up patients for myeloid/lymphoid FCI testing.
•Hematologically abnormal specimens
•Subjects of any range, ethnicities, and racial backgrounds
•Specimens from patients with the following medical indications presenting for testing by flow cytometry based on the Bethesda Consensus Guidelines.

排除标准

•There are two (2) groups of exclusion criteria to detail the specimens that should not be counted for the study:
•Pre-analytical/Pre-screen exclusion criteria
•Post-acquisition exclusion criteria.

结局指标

主要结局

Flow immunophenotyped normal and abnormal

时间窗: immediately after the analysis

Based on WHO guidelines for Leukemia \& Lymphoma

次要结局

未报告次要终点

研究者

发起方

Beckman Coulter, Inc.

申办方类型

Industry

责任方

Sponsor

研究点 (6)

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