Beckman Coulter Expands Portfolio of Standardized ClearLLab IVD Reagents for the Clinical Flow Cytometry Lab

New 10-Color System with Kaluza C Software Streamlines Workflow and QC Reporting for Flow Cytometric Leukemia & Lymphoma* Analysis

Miami, FL (April 24, 2019) ─ Beckman Coulter is launching the ClearLLab 10C System for the clinical flow cytometry lab. The new system is the first 10-color IVD panel of immunophenotyping reagents cleared by the Food and Drug Administration (FDA) for both lymphoid and myeloid lineages. The four dry pre-mixed antibody tubes use the company’s DURA Innovations technology, eliminating the need to pipette antibodies, improving efficiency while reducing potential for human error1, 2.
Alongside the panels, the integrated ClearLLab 10C System comprises

• ClearLLab Control Cells, a liquid preparation of stabilized human erythrocytes and leukocytes (lymphocytes monocytes and granulocytes), are the first application-specific IVD control cells for L&L* immunophenotyping as part of a validated system.
• ClearLLab Control Cells include assay values for the 27 markers currently available on the four ClearLLab10C panels, available for both normal and abnormal controls.
• New ClearLLab Compensation Beads for establishing compensation using the ClearLLab compensation kit, which includes 10 single color tubes for each compensation setup.
• Kaluza C analysis software v 1.1 or higher has enhanced QC features compared to earlier generations of the software.
  

The ClearLLab 10C System incorporates the company’s new Kaluza C software to streamline and standardize clinical QC reporting to inteational guidelines. It delivers high quality results from dry unitized combinations of cluster of differentiation (CD) markers, using Beckman Coulter’s DURA Innovations dry technology. These pre-formulated antibody combinations help the lab avoid the potential errors of manual antibody cocktail preparation.
The four ClearLLab 10C panels are designed specifically to run on Beckman Coulter’s Navios and Navios EX flow cytometers, with new, advanced 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.

With the ClearLLab 10C System, laboratories now have a portfolio of tools for immunophenotyping to aid in providing accurate patient results for L&L* analysis in a compliant lab setting, without needing to carry out extensive manual validation, preparation and QC tasks.
Unique Training Resource − ClearLLab 10C Case Book
ClearLLab 10C is also 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. Labs can also compare the interpretation of their own findings with the analysis in the case book.
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 standardized workflow that delivers greater confidence in the consistency and reliability of their clinical findings.
“Further, it reduces the time-consuming, error-prone pipetting steps in lab developed tests, replacing them with a more time-efficient alteative that also simplifies clinical QC reporting.”
With the ClearLLab 10C System, workflow is reduced to four straightforward, standardized steps – sample processing, sample acquisition, reporting and validation (see Fig 1).
Figure 1

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.
In 2017, the five-color ClearLLab Reagents panels were the first pre-formulated3, IVD antibody cocktails for leukemia and lymphoma* immunophenotyping granted market authorization via the FDA de novo process for in vitro diagnostic use in the US. Its authorization was supported by a manufacturer’s study designed to demonstrate the test’s performance, and compared the test’s results to alteative detection methods. The FDA stated that ClearLLab provided ‘consistent results to aid in the diagnoses of these serious cancers’.
ClearLLab reagents follow the 2006 Bethesda Inteational Consensus Recommendations on the Flow Cytometric Immunophenotypic Analysis of Hematolymphoid Neoplasia4. 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 others5.
*For lymphoma this refers to Non-Hodgkin Lymphoma only

References

1. Rajab A, Axler O, Leung J, Wozniak M, Porwit A. Ten- color 15-antibody flow cytometry panel for immunophenotyping of lymphocyte population. Inteational Joual of Laboratory Hematology 2017 May;39 Suppl 1:76-85. doi: 10.1111/ijlh.12678.
2. Smallwood C, Galama L, Apoll L, Heinrich KH, Demers J, Buchanan S. Examining the economic impact of laboratory defined testing a flow cytometry immunophenotyping for hematologic malignancies: an analysis of heath resource utilization. Poster session presented at: Inteational Society for Pharmacoeconomics and Outcomes Research (ISPOR), 18th Annual European Congress, Milan, Italy. November 09-13, 2015
3. US Food & Drug Administration, Press Announcement, June 29th, 2017: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm565321.htm
4. Davis BH, et al. 2006 Bethesda Inteational 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
5. 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.