DxFLEX 10C Clinical Study

Beckman Coulter

Status: Completed

Conditions: Hematological Malignancy

Treatments: Device: DxFLEX 10C

Study type: Observational

Funder types: Industry

Identifiers

NCT05467449

C76895

Details and patient eligibility

About

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.

Enrollment: 527 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

527 participants in 2 patient groups

Hematologically normal

Description:

Based on immunophenotyping

Treatment:

Device: DxFLEX 10C

Hematologically abnormal

Description:

Based on immunophenotyping

Treatment:

Device: DxFLEX 10C