DxFLEX 10C Clinical Study

Beckman Coulter, Inc.527 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

527

Conditions

Hematological Malignancy

Interventions

DxFLEX 10CDEVICE

A device combining flow cytometry and reagents for immunophenotyping analysis

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: 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: 1. Specimens from new cases or follow up patients for myeloid/lymphoid FCI testing. 2. Hematologically abnormal specimens 3. Subjects of any range, ethnicities, and racial backgrounds 4. Specimens from patients with the following medical indications presenting for testing by flow cytometry based on the Bethesda Consensus Guidelines. Exclusion Criteria: There are two (2) groups of exclusion criteria to detail the specimens that should not be counted for the study: 1. Pre-analytical/Pre-screen exclusion criteria 2. Post-acquisition exclusion criteria.

Locations (6)

NeoGenomics Laboratories

Aliso Viejo, California, United States

University of Miami Miller School of Medicine

Miami, Florida, United States

Quest Diagnostics

Lewisville, Texas, United States

PhenoPath Laboratories, PLLC

Seattle, Washington, United States

Outcomes

Primary Outcomes

Flow immunophenotyped normal and abnormal

Based on WHO guidelines for Leukemia \& Lymphoma

Time frame: immediately after the analysis

Data from ClinicalTrials.gov

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