Glencross Deborah K, Swart Leanne, Pretorius Melanie, Lawrie Denise
Department of Molecular Medicine and Haematology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
Department of Molecular Medicine and Haematology, Charlotte Maxeke Academic Hospital, National Health Laboratory Service, Johannesburg, South Africa.
Afr J Lab Med. 2022 Jul 15;11(1):1458. doi: 10.4102/ajlm.v11i1.1458. eCollection 2022.
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.
The Beckman Coulter (BC) ClearLLab™ 10C (4-tube) system was evaluated against an existing laboratory developed test (LDT).
Peripheral blood and bone marrow aspirates ( = 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.
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.
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.
流式细胞术免疫表型分析在血液系统肿瘤的诊断中已得到广泛应用。新的商用系统提供固定的、预先分装的多参数分析，以简化样本制备并标准化数据分析。
将贝克曼库尔特（BC）ClearLLab™ 10C（4管）系统与现有的实验室自行开发的检测方法（LDT）进行评估比较。
对2019年8月至2019年11月在南非约翰内斯堡的一家学术病理实验室检测的外周血和骨髓穿刺液（n = 101）进行分析。在每日仪器质量控制之后，样本分别按照LDT（使用超过20种2 - 4色内部检测板和广泛的液体单克隆试剂库）或ClearLLab 10C的方法进行制备，并分别使用Becton Dickinson FACSCalibur上的内部方案或BC Navios上的制造商指导方案进行分析。Becton Dickinson Paint-a-Gate或BC Kaluza C软件有助于数据解读。通过计算敏感性和特异性结果来确定诊断准确性（一致性）。
在67例血液系统肿瘤患者和34例无血液系统疾病的参与者中，LDT与ClearLLab 10C之间建立了具有100%特异性和敏感性的极佳一致性（临床诊断一致性）。将ClearLLab 10C与临床病理结果进行比较时，也观察到了类似的可接受诊断一致性（97%）。此外，使用Kaluza C软件分析的ClearLLab 10C检测板能够同时区分疾病以及并发的背景髓系和淋巴系血液群体，包括评估成熟阶段或亚群。
ClearLLab 10C检测板与现有的LDT具有极佳的一致性，可可靠地用于血液系统肿瘤的免疫表型分析，简化并标准化样本制备和数据采集。
