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Flow Cytometry Leukemia/Lymphoma Antibody Panel Receives Approval

By LabMedica International staff writers
Posted on 06 May 2019
A panel of immune-phenotyping flow cytometer reagents that identifies both lymphoid and myeloid cell lines has been granted diagnostic marketing clearance by the [U.S.] Food and Drug Administration to complement its European IVD classification.

The Beckman Coulter (Brea, CA, USA) ClearLLab 10C System offers all components needed: from quality controls, sample preparation and antibody panels to analysis software and training materials. The ClearLLab 10C dry pre-mixed antibody panels rely on DURA Innovations technology, eliminating the need to pipette antibodies, thereby improving efficiency while reducing potential for human error.

Image: Normal and abnormal control cells from the ClearLLab 10C kit (Photo courtesy of Beckman Coulter).
Image: Normal and abnormal control cells from the ClearLLab 10C kit (Photo courtesy of Beckman Coulter).

The DURA (Dry Unitized Reagent Assays) drying process creates a uniform reagent layer at the bottom of the tubes. The reagents do not require refrigeration, which allows the technician to produce a single batch and store it at room temperature for the duration of the study.

The ClearLLab 10C kit contains four premixed, dry 10-color panels: Lymphoid (B-cells, T-cells), Myeloid (M1, M2). In addition, there are normal and abnormal control cells as a liquid preparation of stabilized human erythrocytes and leukocytes. The kit, which was validated for the use on the Beckman Coulter Navios/Navios EX flow cytometers, uses Kaluza C analysis software for data analysis and reporting.

ClearLLab 10C is supported by a unique resource, the ClearLLab 10C case book. The case book provides 24 diagnostic vignettes giving characteristic findings after flow cytometric analysis, with expert assessment by hematopathologists.

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