Beckman Coulter, Miami, Fla, has launched its ClearLLab 10C system for the clinical flow cytometry lab. The new system is the first 10-color in vitro diagnostic (IVD) panel of immunophenotyping reagents cleared by FDA for both lymphoid and myeloid lineages. The four dry, premixed antibody tubes use the company’s Dura innovations technology, eliminating the need to pipette antibodies, improving efficiency while reducing the potential for human error.1, 2
Alongside the panels, the integrated ClearLLab 10C System comprises the following components:
- 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 leukemia and lymphoma immunophenotyping as part of a validated system.
- ClearLLab control cells include assay values for the 27 markers currently available on the four ClearLLab 10C 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 quality control (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 international guidelines. The system delivers high-quality results from dry, unitized combinations of cluster of differentiation (CD) markers, using Beckman Coulter’s Dura innovations dry technology. Such preformulated antibody combinations help labs 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 reagents.
With the ClearLLab 10C system, laboratories now have a portfolio of tools for immunophenotyping to aid in providing accurate patient results for leukemia and lymphoma analysis in a compliant lab setting, without needing to carry out extensive manual validation, preparation, and QC tasks.
ClearLLab 10C is also supported by a unique resource, the ClearLLab 10C Casebook. The casebook provides 24 diagnostic vignettes, giving characteristic findings after flow cytometric analysis, with expert assessment by hematopathologists. Labs can compare the interpretation of their own findings with the analyses in the casebook.
“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,” says Mario Koksch, MD, PhD, MBA, vice president and general manager of Beckman Coulter’s cytometry business unit. “Further, it reduces the time-consuming, error-prone pipetting steps in lab-developed tests, replacing them with a more time-efficient alternative 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 (Figure 1).
The reagents can also be used with peripheral whole blood marrow and lymph node specimens. In 2017, ClearLLab five-color reagent panels were the first preformulated, IVD antibody cocktails for leukemia and lymphoma immunophenotyping granted market authorization via the FDA de novo process for in vitro diagnostic use in the United States.3 FDA authorization was supported by a manufacturer’s study designed to demonstrate the test’s performance, and compared the test’s results to alternative detection methods. FDA stated that the ClearLLab reagents provided consistent results to aid in the diagnoses of these serious cancers.
ClearLLab reagents follow the 2006 Bethesda International Consensus recommendations on the flow cytometric immunophenotypic analysis of hematolymphoid neoplasia.4 They are compatible with the 2016 revised classification of myeloid neoplasms and acute leukemia from the World Health Organization (WHO). In collaboration with the European Association for Hematopathology and the Society for Hematopathology, WHO 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.5
For further information, visit Beckman Coulter.
- Rajab A, Axler O, Leung J, Wozniak M, Porwit A. Ten-color 15-antibody flow cytometry panel for immunophenotyping of lymphocyte population. Int Lab Hematol. 2017; 39(suppl 1):76–85; doi: 10.1111/ijlh.12678.
- Smallwood C, Galama L, Apoll L, Heinrich K, Buchanan S, Demers J. Examining the economic impact of laboratory-developed testing flow cytometry immunophenotyping for hematologic malignancies: an analysis of heath resource utilization [abstract A361]. Poster presented at the annual European Congress of the International Society for Pharmacoeconomics and Outcomes Research, Milan, Italy, November 9–13, 2015. Value Health. 2015;18(7):A361; doi: 10.1016/j.val.2015.09.700.
- FDA allows marketing of test to aid in the detection of certain leukemias and lymphomas [press release, online]. Silver Spring, Md: FDA, 2017. Available at: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm565321.htm. Accessed May 6, 2019.
- Wood BL, Arroz M, Barnett D, 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 B Clin Cytom. 2007; 72(suppl 1):S14–S22; doi: 10.1002/cyto.b.20363.
- Vardiman JW, Thiele J, Arber DA, 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(5):937–951; doi: 10.1182/blood-2009-03-209262.