Clinical quantitative flow cytometry: "Identifying the optimal methods for clinical quantitative flow cytometry".
Clinical quantitative flow cytometry: "Identifying the optimal methods for clinical quantitative flow cytometry".
复制标题
临床定量流式细胞术：“确定临床定量流式细胞术的最佳方法”。
DOI：
10.1002/cyto.b.10053
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发表时间：
2003
期刊：
影响因子：
--
通讯作者：
Stetler-Stevenson,Maryalice
中科院分区：
文献类型：
--
作者：
Marti,GeraldE;VogtJr,RobertF;Stetler-Stevenson,Maryalice
约15种FDA批准的单克隆抗体的引入导致对治疗性抗体（如CD 20（Rituxan）和CD 52（Campath））的临床定量流式细胞术（QFCM）的需求不断增加。在四色和临床QFCM的设置中，出现了一些影响研究和患者护理的问题。由国家癌症中心（NCI）、生物制品评价和研究中心（CBER）、食品和药物管理局（FDA）和疾病控制和预防中心（CDC）共同主办的为期两天的会议“确定临床定量流式细胞术的最佳方法”于2003年4月10-11日在Reston Hyatt会议中心（Reston，VA）举行，以解决这些问题。常规四色分析和需要在治疗之前、期间和之后量化单克隆抗体治疗的治疗靶点的汇合导致了对几个新问题的认识。这些问题包括但不限于同一管中相同缀合物的不同抗体结合能力（ABC）值，这取决于给定四色测定中使用的其他试剂、门控方法以及基于仪器或软件的自动补偿的作用。这次会议审查了这些调查结果，并概述了解决这些问题的步骤。建议草案将于2003年11月12日在弗吉尼亚州阿灵顿举行的临床细胞计数学会会议上提出。还将根据会议记录编写这次会议的摘要。
The introduction of some 15 FDA approved monoclonal antibodies has resulted in increasing requests for Clinical Quantitative Flow Cytometry (QFCM) for therapeutic antibodies, such as CD20 (Rituxan) and CD52 (Campath). In the setting of four color and clinical QFCM, several problems have arisen that effect research and patient care. A two day conference “Identifying the Optimal Methods for Clinical Quantitative Flow Cytometry” co-sponsored by the National Cancer Center (NCI), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) was held April 10-11, 2003 at the Reston Hyatt Conference Center (Reston, VA) to address these problems. The confluence of routine 4-color analysis and a need to quantify therapeutic targets of monoclonal antibody therapy before, during, and after therapy has led to the recognition of several new problems. These problems include but are not limited to differing antibody binding capacity (ABC) values of the same conjugate in the same tube depending on other reagents used in a given 4-color assay, method of gating, and the role of instrument or software based automated compensation. This conference reviewed these findings and outlined steps to address these problems. Draft recommendations will be presented November 12, 2003 at the Clinical Cytometry Society meeting in Arlington, Virginia. A summary of this conference will also be prepared from the transcript.