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.

中文翻译：

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ClearLLab 10C 面板的多中心研究评估


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 试剂盒由四个试剂盒组成（B-Lineage 管、T-Lineage 管和 2 个骨髓谱系管），每个试剂盒由 10 种颜色/10 种抗体缀合物组成，采用 Beckman Coulters 专有的干式格式，针对疑似白血病或疑似白血病患者的调查进行了优化。淋巴瘤。进行了一项多中心研究，以评估 ClearLLab 10C Panel 对疑似血液恶性肿瘤的外周血、骨髓和淋巴结样本中正常表型与异常表型进行定性评估的性能。 ClearLLab 10C 与实验室开发的测试 (LDT) 和最终临床诊断进行了比较。四个临床中心用于登记患者用过的样本（ n = 453）；三个实验室位于北美，一个位于欧洲。在 453 个样本中，198 个没有恶性肿瘤，255 个包含异常群体。 ClearLLab 10C Panel 的诊断准确性达到了患者最终临床诊断的 96% 的敏感性和 95% 的特异性。 ClearLLab10C Panel 和 LDT 之间的表型一致性为 98%。 ClearLLab 10C 和 LDT 之间注意到的任何差异都是由于存在低于检测水平的群体、缺乏向评估人员提供的临床信息或这些组中不存在标记物造成的。总体而言，ClearLLab 10C 与 LDT 和诊断表现出极好的一致性。各个实验室可以采用这四个试剂组来评估是否存在恶性肿瘤。