Department of Pathology and Laboratory Medicine, London Health Sciences Center, London, Ontario, Canada.
Department of Clinical Research, Beckman Coulter, Inc., Miami, Florida, USA.
Cytometry B Clin Cytom. 2021 Mar;100(2):225-234. doi: 10.1002/cyto.b.21935. Epub 2020 Jul 15.
Multiparameter flow cytometry plays an important role in the diagnosis, staging, and monitoring of patients with a suspected hematological malignancy. The ClearLLab 10C Panels consist of four reagent panels (B-Lineage Tube, T-Lineage Tube, and 2 Myeloid Lineage Tubes), each consisting of 10 color/10 antibody conjugates utilizing Beckman Coulters proprietary dry format optimized for investigating patients with suspected leukemia or lymphoma. A multicenter study was conducted to evaluate the performance of the ClearLLab 10C Panels for qualitative assessment of normal versus abnormal phenotype in peripheral blood, bone marrow, and lymph node samples with suspected hematological malignancies. ClearLLab 10C was compared to laboratory developed tests (LDTs) and final clinical diagnosis. Four clinical sites were used to enroll patient's spent specimens (n = 453); three laboratories in North America and one in Europe. Of the 453 specimens, 198 had no malignancy and 255 contained an abnormal population. The diagnostic accuracy of the ClearLLab 10C Panels was achieved with sensitivity of 96% and specificity of 95% with respect to patient final clinical diagnosis. The agreement of phenotyping between ClearLLab10C Panels and LDTs was 98%. Any differences noted between ClearLLab 10C and LDT were due to either the presence of populations below the level of detection, the lack of clinical information provided to the evaluators, or marker(s) not present in these panels. Overall, the ClearLLab 10C demonstrated excellent agreement to LDTs and diagnosis. These four reagent panels can be adopted by individual laboratories to assess the presence or absence of malignancy.
多参数流式细胞术在疑似血液恶性肿瘤患者的诊断、分期和监测中发挥着重要作用。ClearLLab 10C 试剂盒由四个试剂试剂盒组成（B 谱系管、T 谱系管和 2 个髓系谱系管），每个试剂盒包含 10 种颜色/10 种抗体偶联物，采用贝克曼库尔特专有的干格式优化，用于研究疑似白血病或淋巴瘤患者。进行了一项多中心研究，以评估 ClearLLab 10C 试剂盒在定性评估疑似血液恶性肿瘤的外周血、骨髓和淋巴结样本中的正常与异常表型方面的性能。ClearLLab 10C 与实验室开发的测试（LDT）和最终临床诊断进行了比较。四个临床站点被用于招募患者的废弃标本（n=453）；北美三个实验室和欧洲一个实验室。在 453 个标本中，198 个无恶性肿瘤，255 个包含异常群体。ClearLLab 10C 试剂盒的诊断准确性为患者最终临床诊断的敏感性为 96%，特异性为 95%。ClearLLab10C 试剂盒和 LDT 之间表型的一致性为 98%。ClearLLab 10C 与 LDT 之间的任何差异都归因于以下原因：检测水平以下的群体存在、评估者未提供临床信息或这些试剂盒中不存在标记物。总体而言，ClearLLab 10C 与 LDT 和诊断结果具有极好的一致性。这四个试剂试剂盒可被各个实验室采用，以评估恶性肿瘤的存在与否。
