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. 2022 Jul 15;11(1):1458.
doi: 10.4102/ajlm.v11i1.1458. eCollection 2022.

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

Deborah K Glencross  1   2 , Leanne Swart  1   2 , Melanie Pretorius  1   2 , Denise Lawrie  1   2
Affiliations

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

Deborah K Glencross et al. Afr J Lab Med. .

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; diagnostics; fixed-panel; immunophenotyping; leukaemia; lymphoma; multicolour; standardisation.

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Conflict of interest statement

The authors declare they have no financial or personal relationships that may have inappropriately influenced the writing of this article.

Figures

FIGURE 1
FIGURE 1
Comparison of diagnostic immunophenotypic outcomes of cases tested by laboratory developed test and ClearLLab 10C at the Charlotte Maxeke Johannesburg Academic Laboratory in Johannesburg, South Africa, August 2019 – November 2019.
FIGURE 2
FIGURE 2
Part I: Comparison of diagnostic immunophenotypic outcomes of cases tested by the predicate laboratory developed test and ClearLLab 10C at the Charlotte Maxeke Johannesburg Academic Laboratory in Johannesburg, South Africa, during the period from August 2019 – November 2019.
FIGURE 3
FIGURE 3
Part 2: Contingency table comparing the ClearLLab 10C test method (as an objective standard) versus clinicopathological outcomes reported at the Charlotte Maxeke Johannesburg Academic Laboratory in Johannesburg, South Africa, August 2019 – November 2019.
See this image and copyright information in PMC

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