Assessing immunophenotyping performance: Proficiency-validation for adopting improved flow cytometry methods
Assessing immunophenotyping performance: Proficiency-validation for adopting improved flow cytometry methods
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DOI：
10.1002/cyto.b.20176
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发表时间：
2007-07-01
影响因子：
3.4
通讯作者：
Margolick, Joseph B.
中科院分区：
文献类型：
--
作者：
Hultin, Lance E.;Menendez, Frederick A.;Margolick, Joseph B.
背景：免疫细胞表型的不断改进和发展需要实验室方法和技术的定期升级。流式细胞术实验室，参与研究方案主办的NIAID需要进行“开关”的研究，以验证性能的T细胞亚群分析方法之前，可以改变。方法：开关研究进行了四个流式细胞术实验室之间的多中心艾滋病队列研究（MACS），比较2色，溶细胞洗涤方法和一个新的，3色，溶细胞无洗涤方法。其中两个实验室两次未能满足与先前方法的可接受差异的标准。允许这些实验室采用3色、溶血剂免清洗方法，而不是重复更多的转换研究。为了评估在这两个网站的切换到新方法的影响，他们的结果与新方法进行了评价的背景下，所有的实验室参与NIH-NIAID-艾滋病免疫学质量保证司（IQA）熟练度测试program.Results：实验室性能在这两个网站大幅提高相对于IQA标准测试结果。在四个MACS网站和重复样品之间的变化也reduced.Conclusions：虽然开关研究是评估实验室方法的可比性的传统方法，应考虑两种替代方法，重复失败的开关研究的要求：（1）测试新方法并评估能力验证参考样本组的性能，以及（2）在采用新方法之前，对参考样本组样本使用新旧方法，并根据标准统计程序证明新方法的性能更好。这些替代方法可能有助于一些实验室更快地过渡到新的和上级的方法，而不是要求他们尝试多个连续的转换研究。(c)2007年临床细胞计数学会。
Background: The continuous improvement and evolution of immune cell phenotyping requires periodic upgrading of laboratory methods and technology. Flow cytometry laboratories that are participating in research protocols sponsored by the NIAID are required to perform "switch" studies to validate performance before methods for T-cell subset analysis can be changed.Methods: Switch studies were conducted among the four flow cytometry laboratories of the Multicenter AIDS Cohort Study (MACS), comparing a 2-color, lyse-wash method and a newer, 3-color, lyse no-wash method. Two of the laboratories twice failed to satisfy the criteria for acceptable differences from the previous method. Rather than repeating more switch studies, these laboratories were allowed to adopt the 3-color, lyse no-wash method. To evaluate the impact of the switch to the new method at these two sites, their results with the new method were evaluated within the context of all laboratories participating in the NIH-NIAID-Division of AIDS Immunology Quality Assurance (IQA) proficiency-testing program.Results: Laboratory performance at these two sites substantially improved relative to the IQA standard test results. Variation across the four MACS sites and across replicate samples was also reduced.Conclusions: Although switch studies are the conventional method for assessing comparability of laboratory methods, two alternatives to the requirement of repeating failed switch studies should be considered: (1) test the new method and assess performance on the proficiency testing reference panel, and (2) prior to adoption of the new methods, use both the old and the new method on the reference panel samples and demonstrate that performance with the new method is better according to standard statistical procedures. These alternatives may help some laboratories' transition to a new and superior methodology more quickly than if they are required to attempt multiple, serial switch studies. (c) 2007 Clinical Cytometry Society.