ClearLLab Flow Cytometry Products Improve Lab Workflow

Beckman Coulter’s ClearLLab flow cytometry reagents deliver the first preformulated, IVD antibody cocktails for leukemia and lymphoma* immunophenotyping in the clinical lab.

This means laboratories no longer have to develop their own laboratory developed test (LDT), a technically demanding, manual, time-consuming, and potentially error-prone process. Previously, labs had to validate their own antibody cocktails. ClearLLab automates and standardizes the process.

The reagents are the first to receive Food and Drug Administration (FDA) clearance (via the De Novo Process) to market them in the US. See ‘FDA allows marketing of test to aid in the detection of certain leukemias and lymphomas’ with the FDA confirming that the test ‘provides consistent results to aid in the diagnoses of these serious cancers’. The FDA evaluated data from a multi-site clinical study which compared panel results to alternative detection methods.

Reduce Manual Preparation and Routine Validation

Beckman Coulter’s Miami operation is already globally recognized as a center of innovation for the development of clinical flow systems**. The company is now building on this expertise to develop a new and advanced range of clinical flow systems to be launched over the next five years. They specifically address the diagnostic challenges and differing workflow requirements of clinical laboratories, worldwide.

ClearLLab delivers fast and accurate qualitative identification of various hematolymphoid cell populations by immunophenotyping on the FC500 flow cytometer. With the reliability of a standardized kit and protocols, the premixed combinations:

• Reduce manual error and validation time

• Accelerate sample preparation time

• Improve workflow

• Streamline lab inventory management

• Provide confidence in the accuracy and reliability of results.

Dr Mario Koksch, Vice President and General Manager of Beckman Coulter’s Cytometry Business Unit said: "Flow cytometry is a powerful tool for the detailed and fast analysis of complex populations, with the technique becoming increasingly valuable to the clinical hematology laboratory.

“The routine use of ready-to-use ClearLLab reagents delivers greater efficiency and cost savings. Preformulated antibody combinations enable the lab to avoid the potential errors of manual antibody cocktail preparation, with the reassurance of standardized reporting to international guidelines.”

ClearLLab reagents follow the 2006 Bethesda International Consensus Recommendations on the Flow Cytometric Immunophenotypic Analysis of Hematolymphoid Neoplasia. They are compatible with the World Health Organization (WHO) 2016-revised classification of myeloid neoplasms and acute leukemia. WHO, in collaboration with the European Association for Hematopathology and the Society for Hematopathology, recently made important changes to the classification of these diseases. These included new criteria for the recognition of some previously described neoplasms as well as clarification and refinement of the defining criteria for others.

For more ClearLLab information please click here. 

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*For lymphoma this refers to Non-Hodgkin’s lymphoma only

** Beckman Coulter Life Sciences is a separate company from Beckman Coulter Diagnostics and produces clinical flow cytometry systems for both Danaher companies.