A North American multilaboratory study of CD4 counts using flow cytometric PanLeukogating (PLG): A NIAID-DAIDS immunology quality assessment program study
A North American multilaboratory study of CD4 counts using flow cytometric PanLeukogating (PLG): A NIAID-DAIDS immunology quality assessment program study
复制标题
DOI：
10.1002/cyto.b.20417
复制
发表时间：
2008-01-01
影响因子：
3.4
通讯作者：
Glencross, Deborah K.
中科院分区：
文献类型：
--
作者：
Denny, Thomas N.;Gelman, Rebecca;Glencross, Deborah K.
背景资料：全球艾滋病毒/艾滋病大流行以及启动抗逆转录病毒治疗（ART）和机会性感染预防的指导方针需要负担得起的，可靠的和准确的CD 4检测。一个简单的创新方法，适用于现有的技术，已成功地应用于资源挑战的设置，泛Leukogated CD 4（PLG），可以提供解决方案，节省成本和提高precision.Methods：从99个HIV+捐助者的日龄全血同时研究了在五个北美实验室的性能比较，他们的谓词方法与双平台PLG方法。实质等同技术包括不同流式细胞仪上的不同四色CD 45/CD 3/CD 4/CD 8方案。每个实验室还分析了来自10至14名当地供体的8份日龄血液重复样本。结果：显著（P < 0.0001）提高了实验室间的精密度/变异系数（使用PLG方法注意到CM（总体中位数9.3% vs.谓词中位数CV 13.1%）。使用PLG（中位数4.6% vs.同品种器械CV中位数6.2%）和5个实验室中的3个实验室的实验室内精密度总体上也显著（P < 0.0001）更好。PLG计数往往比等同方法小11%（P < 0.0001）对于运输（同品种器械PLG的中位数= 31）和当地样本（同品种器械-PLG的中位数= 23），总体和4/5个实验室（运送标本中位值分别减少4、16、20和21%）;其他实验室中位值增加5%。结论：如果CD 4计数的变化（通常是下降）对其卫生系统是可接受的，则使用与本研究中类似的等同CD 4方法的实验室可以通过在充分培训后改用PLG方法来提高其实验室间和实验室内精密度，并降低成本。(C)2008年临床细胞计数学会。
Background: The global HIV/AIDS pandemic and guidelines for initiating anti-retroviral therapy (ART) and opportunistic infection prophylaxis demand affordable, reliable, and accurate CD4 testing. A simple innovative approach applicable to existing technology that has been successfully applied in resource-challenged settings, PanLeukogated CD4 (PLG), could offer solutions for cost saving and improved precision.Methods: Day-old whole blood from 99 HIV+ donors was simultaneously studied in five North-American laboratories to compare the performance of their predicate methods with the dual-platform PLG method. The predicate technology included varying 4-color CD45/CD3/CD4/CD8 protocols on different flow cytometers. Each laboratory also assayed eight replicate specimens of day-old blood from 10 to 14 local donors. Bias and precision of predicate and PLG methods was studied between- and within-participating laboratories.Results: Significantly (P < 0.0001) improved between-laboratory precision/coefficient of variation (CM was noted using the PLG method (overall median 9.3% vs. predicate median CV 13.1%). Within-laboratory precision was also significantly (P < 0.0001) better overall using PLG (median 4.6% vs. predicate median CV 6.2%) and in 3 of the 5 laboratories. PLG counts tended to be 11% smaller than predicate methods (P < 0.0001) for shipped (median of predicate-PLG = 31) and local specimens (median of predicate-PLG = 23), both overall and in 4 of 5 laboratories (median decreases of 4, 16, 20, and 21% in shipped specimens); the other laboratory had a median increase of 5%.Conclusion: Laboratories using predicate CD4 methods similar to those in this study could improve their between-laboratory and their within-laboratory precision, and reduce costs, by switching to the PLG method after adequate training, if a change (usually, a decrease) in CD4 counts is acceptable to their health systems. (C) 2008 Clinical Cytometry Society.