Beckman Coulter Expands Portfolio of Standardised ClearLLab CE-IVD Reagents for the Clinical Flow Cytometry Lab
20 Jan 2019
Beckman Coulter has launched the ClearLLab 10C System for the clinical flow cytometry lab. The system includes the first ten-colour CE-IVD panels of immunophenotyping reagents for both lymphoid and myeloid lineages.
The ClearLLab 10C System incorporates the company’s Kaluza C software to streamline and standardise clinical QC reporting to international guidelines. It delivers high quality results from dry unitised combinations of CD (cluster of differentiation) markers, using Beckman Coulter’s DURA Innovations dry technology. The pre-formulated antibody combinations are designed to help labs avoid the potential errors of manual antibody cocktail preparation.
Four ClearLLab 10C panels are designed specifically to run on Navios and Navios EX flow cytometers, with advanced Navios compensation setup software. When using the ClearLLab 10C system, compensation is only required on initial set-up of the application, when daily QC fails, after instrument service as needed, or when switching to a new lot of Flow-Set Pro.
ClearLLab 10C is supported by the ClearLLab 10C case book, which provides 24 diagnostic vignettes giving characteristic findings after flow cytometric analysis, with expert assessment by haematopathologists. Labs can also compare the interpretation of their own findings with the analysis in the casebook.
Dr Mario Koksch, Vice President and General Manager of Beckman Coulter’s Cytometry Business Unit, said: "The ClearLLab 10C System is an integrated solution, offering labs standardised workflow that delivers greater confidence in the consistency and reliability of their clinical findings.
“Further, it reduces the time-consuming, error-prone pipetting steps of lab developed tests, replacing them with a more time-efficient alternative that also simplifies clinical QC reporting.”
The reagents can be used with peripheral whole blood (collected in K2EDTA, Acid Citrate Dextrose (ACD) or Heparin), bone marrow (collected in K2EDTA, Acid Citrate Dextrose (ACD) or Heparin) and lymph node specimens.
As well as the panels, the system features:
• ClearLLab Control Cells - a liquid preparation of stabilised human erythrocytes and leukocytes (lymphocytes monocytes and granulocytes). ClearLLab Control Cells include assay values for the 27 markers currentlyavailable on the four ClearLLab10C panels, available for both normal and abnormal controls.
• ClearLLab Compensation Beads for establishing compensation using the ClearLLab compensation kit, which includes ten single colour tubes for each compensation setup.
• Enhanced QC features of Kaluza C analysis software, v1.1 or higher.