The ISHAGE guidelines for CD34+ cell determination by flow cytometry. International Society of Hematotherapy and Graft Engineering.

The ISHAGE guidelines for CD34+ cell determination by flow cytometry. International Society of Hematotherapy and Graft Engineering.
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DOI:
10.1089/scd.1.1996.5.213
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发表时间:
1996-06-01
期刊:
Journal of hematotherapy
影响因子:
--
通讯作者:
Chin-Yee, I
Chin-Yee, I
中科院分区:
其他
文献类型:
--
作者:
Sutherland, D R;Anderson, L;Chin-Yee, I

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外周血干细胞(Peripheral Blood Stem Cells, PBSC)在自体移植和最近的同种异体移植中用于重建造血功能的使用越来越多,但对外周血干细胞产品的质量控制尚无共识。由于携带CD34抗原的一小部分细胞被认为是多系移植的原因,因此CD34+细胞的流式细胞术定量移植评估应该提供一种快速、可靠和可重复的检测方法。不幸的是,尽管已经描述了许多用于CD34枚举的流式细胞分析,但由于缺乏标准化的方法,导致产生了广泛不同的数据。此外,这些检测都没有得到实验室间可重复性和广泛临床应用适用性的验证。1995年初,国际血液治疗和移植工程学会(ISHAGE)成立了一个干细胞计数委员会,其任务是验证一种简单、快速、敏感的流式细胞术方法,以定量外周血和单采产物中的CD34+细胞。我们还试图在临床实验室的各种流式细胞仪上建立其效用,并在移植中心之间建立其可重复性。在这里,我们描述了在北美的一项多中心研究中,ISHAGE采用的四参数流方法进行验证。
The increased use of Peripheral Blood Stem Cells (PBSC) to reconstitute hematopoiesis in autotransplant and, more recently, allotransplant settings has not been associated with a consensus means to quality control the PBSC product. Since the small population of cells that bear the CD34 antigen are thought to be responsible for multilineage engraftment, graft assessment by flow cytometric quantitation of CD34+ cells should provide a rapid, reliable, and reproducible assay. Unfortunately, although a number of flow cytometric assays for CD34 enumeration have been described, the lack of a standardized method has led to the generation of widely divergent data. Furthermore, none of these assays has been validated as to interlaboratory reproducibility and suitability for widespread clinical application. In early 1995, the International Society of Hematotherapy and Graft Engineering (ISHAGE) established a Stem Cell Enumeration Committee, the mandate of which was to validate a simple, rapid, and sensitive flow cytometric method to quantitate CD34+ cells in peripheral blood and apheresis products. We also sought to establish its utility on a variety of flow cytometers in clinical laboratories and its reproducibility between transplant centers. Here, we describe the four-parameter flow methodology adopted by ISHAGE for validation in a multicenter study in North America.