Beckman Coulter Life Sciences has expanded its portfolio of clinical flow cytometry solutions with its latest innovations ranging from portfolio extensions to its range of single-color antibodies, high quality IVD panels and customized solutions. They were all highlighted at the 70th American Association for Clinical Chemistry (AACC) Annual Scientific Meeting and Clinical Laboratory Expo (CLE), held July 2018 in Chicago, USA. Beckman Coulter Life Sciences, part of the Danaher Corporation, exhibited on booth #3612 alongside Beckman Coulter Diagnostics (another Danaher company).
Bringing more than 30 years’ experience in manufacturing reagents, the latest innovations include:
• ClearLLab CaseBook 5C, a step by step illustrative resource into complex pattern recognition for leukemia and certain lymphomas, using the ClearLLab panel of reagents. These are the first preformulated, IVD antibody cocktails for L and L immunophenotyping in the clinical lab. (More below).
• Enhanced portfolio of single color CE-IVD and analyte-specific reagents (ASR); all manufactured under Good Manufacturing Practices.
• DURA Innovations dry reagent technology, available in a range of services and reagents including ClearLLab.
• Expanded external business resources - the LUCID custom design and cocktailing services and RESOURCE contract manufacturing services, both of which are underpinned by DURA Innovations.
Flow cytometric immunophenotyping is a rapidly evolving IVD technology which is establishing a place in the routine lab for the assessment of leukemia and certain lymphomas,” explained Dr Mario Koksch, Vice President and General Manager of Beckman Coulter’s Cytometry Business Unit. “At the heart of the test is a panel of antibodies that can detect markers or antigens on the cells. However, this depends on the accurate interpretation of complex patterns, determining whether a pattern is consistent (normal) or inconsistent with an expected population.”
To aid in this complex pattern recognition, the company has developed a unique educational resource, the ClearLLab CaseBook. Users can also download the data to continue their diagnostic practice. The casebook is based on the ClearLLab 5C reagents which were the first preformulated, IVD antibody cocktails for leukemia and lymphoma immunophenotyping to be granted de novo authorization by the Food and Drug Administration (FDA) for in vitro diagnostic use. ClearLLab reagents simplify and standardize the process. Dr Koksch explained: “By standardizing the process, ClearLLab has removed one of the limitations to flow cytometry gaining its place in the routine lab, removing the need for a lab to manually prepare and design panels, a time- consuming process.”
Identifying the Aberrant Immunophenotype
The ClearLLab 5C Casebook provides the clinical history of 16 patients, illustrating the progressive analysis of flow cytometric immunophenotyping data by means of numerous color-coded illustrated scatter plots. These first assess and then assign the cells before giving a detailed characterization of the aberrant population according to the presence or absence of antigens. It includes patients with characteristic findings typical of various lymphoid and myeloid neoplasms as well as those with clinical and/or laboratory findings suggesting an underlying neoplastic process, but in which no immunophenotypic abnormality is identified. Specimen types include peripheral blood, bone marrow, and lymph nodes. Each case concludes with an assessment of the immunophenotypic findings as well as potential pitfalls. Dr Koksch added: “Flow cytometry has several advantages over immunohistochemistry in cancer detection. This includes its ability to define distinct cell populations by their size and granularity, exclude weakly expressed surface antigens and measure several antigens at the same time with multi-color analysis.”
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