Hematological Malignancy
Conditions
Brief summary
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.
Interventions
DEVICEDxFLEX 10C
A device combining flow cytometry and reagents for immunophenotyping analysis
Sponsors
Beckman Coulter, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Flow immunophenotyped normal and abnormal | immediately after the analysis | Based on WHO guidelines for Leukemia & Lymphoma |
Countries
Canada, Germany, United States
Outcome results
None listed