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

African Journal of Laboratory Medicine

 
 
Field Value
 
Title Evaluation of fixed-panel, multicolour ClearLLab 10C at an academic flow cytometry laboratory in Johannesburg, South Africa
 
Creator Glencross, Deborah K. Swart, Leanne Pretorius, Melanie Lawrie, Denise
 
Subject health; pathology; laboratory science ClearLLab 10C; immunophenotyping; fixed-panel; standardisation; multicolour; leukaemia; lymphoma; diagnostics
Description 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. 
 
Publisher AOSIS
 
Contributor Funding for this study was made possible with research incentive funds accrued to DK Glencross, awarded to her by the University of the Witwatersrand.
Date 2022-07-15
 
Type info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion — prospective comparison of diagnostic outcomes
Format text/html application/epub+zip text/xml application/pdf
Identifier 10.4102/ajlm.v11i1.1458
 
Source African Journal of Laboratory Medicine; Vol 11, No 1 (2022); 10 pages 2225-2010 2225-2002
 
Language eng
 
Relation
The following web links (URLs) may trigger a file download or direct you to an alternative webpage to gain access to a publication file format of the published article:

https://ajlmonline.org/index.php/ajlm/article/view/1458/2297 https://ajlmonline.org/index.php/ajlm/article/view/1458/2298 https://ajlmonline.org/index.php/ajlm/article/view/1458/2299 https://ajlmonline.org/index.php/ajlm/article/view/1458/2300
 
Coverage Gauteng; South Africa 2020 all
Rights Copyright (c) 2022 Deborah K. Glencross, Leanne Swart, Melanie Pretorius, Denise Lawrie https://creativecommons.org/licenses/by/4.0
ADVERTISEMENT