Original Research

Evaluation of fixed-panel, multicolour ClearLLab 10C at an academic flow cytometry laboratory in Johannesburg, South Africa

Deborah K. Glencross, Leanne Swart, Melanie Pretorius, Denise Lawrie
African Journal of Laboratory Medicine | Vol 11, No 1 | a1458 | DOI: https://doi.org/10.4102/ajlm.v11i1.1458 | © 2022 Deborah K. Glencross, Leanne Swart, Melanie Pretorius, Denise Lawrie | This work is licensed under CC Attribution 4.0
Submitted: 19 November 2020 | Published: 15 July 2022

About the author(s)

Deborah K. Glencross, Department of Molecular Medicine and Haematology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; and, Department of Molecular Medicine and Haematology, Charlotte Maxeke Academic Hospital, National Health Laboratory Service, Johannesburg, South Africa
Leanne Swart, Department of Molecular Medicine and Haematology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; and, Department of Molecular Medicine and Haematology, Charlotte Maxeke Academic Hospital, National Health Laboratory Service, Johannesburg, South Africa
Melanie Pretorius, Department of Molecular Medicine and Haematology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; and, Department of Molecular Medicine and Haematology, Charlotte Maxeke Academic Hospital, National Health Laboratory Service, Johannesburg, South Africa
Denise Lawrie, Department of Molecular Medicine and Haematology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; and, Department of Molecular Medicine and Haematology, Charlotte Maxeke Academic Hospital, National Health Laboratory Service, Johannesburg, South Africa


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Abstract

Background: Flow cytometric immunophenotyping is well established for the diagnosis of haematological neoplasms. New commercially available systems offer fixed, pre-aliquoted multi-parameter analysis to simplify sample preparation and standardise data analysis.

Objective: The Beckman Coulter (BC) ClearLLab™ 10C (4-tube) system was evaluated against an existing laboratory developed test (LDT).

Methods: Peripheral blood and bone marrow aspirates (n = 101), tested between August 2019 and November 2019 at an academic pathology laboratory in Johannesburg, South Africa, were analysed. Following daily instrument quality control, samples were prepared for LDT (using > 20 2–4-colour in-house panels and an extensive liquid monoclonal reagent repertoire) or ClearLLab 10C, and respectively analysed using in-house protocols on a Becton Dickinson FACSCalibur, or manufacturer-directed protocols on a BC Navios. Becton Dickinson Paint-a-Gate or BC Kaluza C software facilitated data interpretation. Diagnostic accuracy (concordance) was established by calculating sensitivity and specificity outcomes.

Results: Excellent agreement (clinical diagnostic concordance) with 100% specificity and sensitivity was established between LDT and ClearLLab 10C in 67 patients with a haematological neoplasm and 34 participants with no haematological disease. Similar acceptable diagnostic concordance (97%) was noted when comparing ClearLLab 10C to clinicopathological outcomes. Additionally, the ClearLLab 10C panels, analysed with Kaluza C software, enabled simultaneous discrimination of disease and concurrent background myeloid and lymphoid haematological populations, including assessing stages of maturation or sub-populations.

Conclusion: ClearLLab 10C panels provide excellent agreement to existing LDTs and may reliably be used for immunophenotyping of haematological neoplasms, simplifying and standardising sample preparation and data acquisition.

 


Keywords

ClearLLab 10C; immunophenotyping; fixed-panel; standardisation; multicolour; leukaemia; lymphoma; diagnostics

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