Krzywdzińska Agnieszka, Puła Bartosz, Czyż Anna, Krzymieniewska Beata, Kiernicka-Parulska Jolanta, Mierzwa Anna, Szymczak Donata, Milanowska Aneta, Kiraga Aleksandra, Kwiecień Iwona, Zaleska Joanna, Jamroziak Krzysztof
Laboratory of Immunophenotyping, Institute of Hematology and Transfusion Medicine, 02-776 Warsaw, Poland.
Department of Hematology, Institute of Hematology and Transfusion Medicine, 02-776 Warsaw, Poland.
Diagnostics (Basel). 2021 Oct 11;11(10):1872. doi: 10.3390/diagnostics11101872.
Minimal residual disease (MRD) status is now considered as one of the most relevant prognostic factors in multiple myeloma (MM) while MRD negativity became an important endpoint in clinical trials. Here, we report the results of the first study evaluating the reproducibility of high-sensitivity flow cytometry MM MRD assessment in four laboratories in Poland. EuroFlow protocols for instrument setting standardization and sample preparation in MM MRD assessment were implemented in each laboratory. In the inter-laboratory reproducibility study, 12 bone marrow samples from MM patients were distributed and processed in participant laboratories. In the inter-operator concordance study, 13 raw data files from MM MRD measurements were analyzed by five independent operators. The inter-laboratory study showed high 95% overall concordance of results among laboratories. In the inter-operator study, 89% of MRD results reported were concordant, and the highest immunophenotype interpretation differences with regard to expression of CD27, CD45, CD81 were noticed. We confirmed the applicability and feasibility of the EuroFlow protocol as a highly sensitive method of MRD evaluation in MM. Results of our inter-center comparison study demonstrate that the standardization of MM MRD assessment protocols is highly desirable to improve quality and comparability of results within and between different clinical trials.
微小残留病（MRD）状态现已被视为多发性骨髓瘤（MM）中最相关的预后因素之一，而MRD阴性成为临床试验中的一个重要终点。在此，我们报告了第一项评估波兰四个实验室中高灵敏度流式细胞术MM MRD评估可重复性的研究结果。每个实验室都实施了用于MM MRD评估中仪器设置标准化和样本制备的EuroFlow方案。在实验室间可重复性研究中，向参与实验室分发并处理了12例MM患者的骨髓样本。在操作者间一致性研究中，由五名独立操作者分析了13份来自MM MRD测量的原始数据文件。实验室间研究显示实验室间结果的总体一致性高达95%。在操作者间研究中，报告的MRD结果有89%一致，并且在CD27、CD45、CD81表达方面发现了最高的免疫表型解释差异。我们证实了EuroFlow方案作为MM中MRD评估的一种高灵敏度方法的适用性和可行性。我们的中心间比较研究结果表明，非常需要对MM MRD评估方案进行标准化，以提高不同临床试验内部和之间结果的质量和可比性。
