ClearLLab Antibody Solutions
Beckman Coulter is revolutionizing the leukemia and lymphoma analysis in clinical flow cytometry laboratories with the innovative ClearLLab Solutions:
- ClearLLab 10C system is an integrated CE-IVD leukemia and lymphoma*(L&L) immunophenotyping solution for lymphoid and myeloid lineages
- ClearLLab LS Lymphoid Screen antibody panel is the first CE-IVD-marked 10-color assay for L&L analysis
- ClearLLab Reagents are the first reagents to receive US Food and Drug Administration (FDA) clearance (via the De Novo Process) for L&L flow cytometric immunophenotyping in the clinical lab.
- ClearLLab Antibody solutions are compatible with current Clinical Guidelines
*For Non-Hodgkin’s lymphoma only
ClearLLab 10C system
The CE-IVD ClearLLab 10C system covers lymphoid and myeloid lineages, without the need for extensive validation and hard to find clinically relevant samples, while offering a streamlined workflow. The CE-IVD solution offers all components needed from quality controls, sample preparation, antibody panels to analysis software and training material.
ClearLLab Control Cells are the first application specific normal and abnormal CE-IVD controls cells as a liquid preparation of stabilized human erythrocytes and leukocytes. The ClearLab 10C System is validated for the use on the Navios / Navios EX flow cytometers and with Kaluza C analysis software for data analysis and reporting.
ClearLLab LS Lymphoid Screen
ClearLLab LS Lymphoid Screen antibody panel is the first CE-IVD-marked 10-color assay for leukemia* and lymphoma analysis. Compared to Laboratory Developed Tests (LDT), the dry ClearLLab LS delivers greater confidence in results with a faster turnaround time (TAT) due to its innovative workflow. It eliminates 14 manual workflow steps, while streamlining five others; and is available through a dry unitized, ready to use formulation. ClearLLab LS has been specifically designed for the fast and accurate identification of haematolymphoid cell populations on the company’s Navios and Navios EX flow cytometers. The ClearLLab Compensation Kit (B74073) is available to facilitate compensation setup for the ClearLLab LS Lymphoid Screen Reagent (PN B74073).
ClearLLab Reagents are the first reagents to receive US Food and Drug Administration (FDA) clearance (via the De Novo Process) for leukemia and lymphoma* flow cytometric immunophenotyping in the clinical lab. They are comprised of five pre-formulated antibody cocktails targeted at B-, T-, and Myeloid cell malignancies. For clinical laboratories, adopting the ClearLLab assays means reducing their number of Laboratory Developed Test (LDT) they need to develop and prepare, a technically demanding, time-consuming, and potentially error-prone process. ClearLLab reagents have been specifically designed for the fast and accurate identification of a number of haematolymphoid cell populations on the company’s FC500 flow cytometer.
Compliance with Clinical Guidelines
ClearLLab Reagents follow the 2006 Bethesda International Consensus Recommendations on the Flow Cytometric Immunophenotypic Analysis of Hematolymphoid Neoplasia1. ClearLLab Reagents and ClearLLab LS are compatible with the World Health Organization (WHO) 2016-revised classification of myeloid neoplasms and acute leukemia2.
*For Non-Hodgkin’s lymphoma only
1 Davis BH, et al. 2006 Bethesda International Consensus Recommendations on the Immunophenotypic Analysis of Hematolymphoid Neoplasia by Flow Cytometry: Optimal Reagents and Reporting for the Flow Cytometric Diagnosis of Hematopoietic Neoplasia. Cytometry Part B (Clinical Cytometry 2007 72B: S5-S13
2 Vardiman JW, Arber DA, Brunning DR et al. The 2008 revision of the World Health Organization (WHO) classification of myeloid neoplasms and acute leukemia: rationale and important changes. Blood 2009 114:937-951; doi: 10.1182/blood-2009-03-209262
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