Establishment and validation of a standard protocol for the detection of minimal residual disease in B lineage childhood acute lymphoblastic leukemia by flow cytometry in a multi-center setting
Establishment and validation of a standard protocol for the detection of minimal residual disease in B lineage childhood acute lymphoblastic leukemia by flow cytometry in a multi-center setting
复制标题
DOI：
10.3324/haematol.2008.000414
复制
发表时间：
2009-06-01
期刊：
影响因子：
--
通讯作者：
Lawson, Sarah
中科院分区：
文献类型：
--
作者：
Irving, Julie;Jesson, Jenny;Lawson, Sarah
微小残留病检测，用于急性淋巴细胞白血病儿童的临床管理，可以通过抗原受体基因重排的分子分析或异常免疫表型的流式细胞术分析进行。为了将血流微小残留病纳入更大的国家和国际试验，需要一种质量有保证的标准化方法，该方法可以在多中心环境中进行。我们报告了一个四色，流式细胞术的协议建立和验证的英国急性淋巴细胞白血病流微小残留病组。质量保证检测得到了较高的实验室间一致性，在对数标度上，与中位共识值的差异不超过一个点。对206例B-ALL患者的前瞻性筛查显示，该方法适用于88.3%的患者。对骨髓抽吸物中的微小残留病变进行定量，并与分子数据进行比较。合并风险类别一致性（微小残留疾病水平高于或低于0.01%）为86%（n=134）。因此，该标准化方案在实验室之间具有高度重现性，灵敏度高，适用性好，并与基于分子的分析具有良好的一致性。
Minimal residual disease detection, used for clinical management of children with acute lymphoblastic leukemia, can be performed by molecular analysis of antigen-receptor gene rearrangements or by flow cytometric analysis of aberrant immunophenotypes. For flow minimal residual disease to be incorporated into larger national and international trials, a quality assured, standardized method is needed which can be performed in a multi-center setting. We report a four color, flow cytometric protocol established and validated by the UK acute lymphoblastic leukemia Flow minimal residual disease group. Quality assurance testing gave high inter-laboratory agreement with no values differing from a median consensus value by more than one point on a logarithmic scale. Prospective screening of B-ALL patients (n=206) showed the method was applicable to 88.3% of patients. The minimal residual disease in bone marrow aspirates was quantified and compared to molecular data. The combined risk category concordance (minimal residual disease levels above or below 0.01%) was 86% (n=134). Thus, this standardized protocol is highly reproducible between laboratories, sensitive, applicable, and shows good concordance with molecular-based analysis.