Department of Laboratory Medicine, Eunpyeong St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.
Department of Laboratory Medicine, Incheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.
Ann Lab Med. 2024 May 1;44(3):222-234. doi: 10.3343/alm.2023.0298. Epub 2023 Dec 26.
Flow cytometric immunophenotyping of hematolymphoid neoplasms (FCI-HLN) is essential for diagnosis, classification, and minimal residual disease (MRD) monitoring. FCI-HLN is typically performed using in-house protocols, raising the need for standardization. Therefore, we surveyed the current status of FCI-HLN in Korea to obtain fundamental data for quality improvement and standardization.
Eight university hospitals actively conducting FCI-HLN participated in our survey. We analyzed responses to a questionnaire that included inquiries regarding test items, reagent antibodies (RAs), fluorophores, sample amounts (SAs), reagent antibody amounts (RAAs), acquisition cell number (ACN), isotype control (IC) usage, positive/negative criteria, and reporting.
Most hospitals used acute HLN, chronic HLN, plasma cell neoplasm (PCN), and MRD panels. The numbers of RAs were heterogeneous, with a maximum of 32, 26, 12, 14, and 10 antibodies used for acute HLN, chronic HLN, PCN, ALL-MRD, and multiple myeloma-MRD, respectively. The number of fluorophores ranged from 4 to 10. RAs, SAs, RAAs, and ACN were diverse. Most hospitals used a positive criterion of 20%, whereas one used 10% for acute and chronic HLN panels. Five hospitals used ICs for the negative criterion. Positive/negative assignments, percentages, and general opinions were commonly reported. In MRD reporting, the limit of detection and lower limit of quantification were included.
This is the first comprehensive study on the current status of FCI-HLN in Korea, confirming the high heterogeneity and complexity of FCI-HLN practices. Standardization of FCI-HLN is urgently needed. The findings provide a reference for establishing standard FCI-HLN guidelines.
血液淋巴肿瘤的流式细胞免疫表型分析(FCI-HLN)对于诊断、分类和微小残留病(MRD)监测至关重要。FCI-HLN 通常使用内部协议进行,因此需要标准化。因此,我们调查了韩国 FCI-HLN 的现状,以获得质量改进和标准化的基本数据。
八所积极开展 FCI-HLN 的大学医院参与了我们的调查。我们分析了对问卷的回答,问卷中包括了关于测试项目、试剂抗体(RAs)、荧光染料、样本量(SAs)、试剂抗体量(RAAs)、采集细胞数(ACN)、同型对照(IC)使用、阳性/阴性标准以及报告的问题。
大多数医院使用急性 HLN、慢性 HLN、浆细胞肿瘤(PCN)和 MRD 面板。RAs 的数量存在差异,急性 HLN、慢性 HLN、PCN、ALL-MRD 和多发性骨髓瘤-MRD 分别使用最多 32、26、12、14 和 10 种抗体。荧光染料的数量从 4 到 10 不等。RAs、SAs、RAAs 和 ACN 各不相同。大多数医院使用 20%的阳性标准,而急性和慢性 HLN 面板则使用 10%。五家医院使用 IC 作为阴性标准。阳性/阴性赋值、百分比和一般意见通常被报告。在 MRD 报告中,包括检测限和定量下限。
这是韩国首次对 FCI-HLN 现状进行的全面研究,证实了 FCI-HLN 实践的高度异质性和复杂性。迫切需要标准化 FCI-HLN。研究结果为制定标准的 FCI-HLN 指南提供了参考。