National HIV Immunology Laboratory, Public Health Agency of Canada, Ottawa, Ontario, Canada K1A 0K9.
Cytometry B Clin Cytom. 2010 May;78(3):188-93. doi: 10.1002/cyto.b.20501.
Efforts to improve alternative CD4 T-cell counting methods are critical to accelerate the implementation of HIV antiretroviral therapy in resources limited regions. Substituting liquid format reagents to eliminate cold-chain transportation and refrigerated storage with dry format reagents contributes to higher efficiency supply management solution especially for laboratories at remote locations. ReaMetrix has developed dry format reagent kits compatible with the FACSCount system, a dedicated flow cytometer for T-cell subset enumeration widely used in resource limited settings. A dual site collaborative study was designed to compare T-cell subsets using both the new dry format ReaMetrix reagent and the original BD Biosciences liquid reagents.
A total of 167 HIV positive samples prepared with Rea T Count (ReaMetrix) and FACSCount (BD Biosciences) reagents were analyzed using FACSCount Systems. To compare both methods, Bland-Altman, Pollock, Scott % similarity and correlation coefficient statistical analysis was applied. Immuno-Trol served as an assay processing control and quality indicator of interlaboratory and intralaboratory variation.
The mean bias and limits of agreement for CD4 T-cell measurements between Rea T Count and FACSCount reagents were -16 cells/microl (-4.6%) and -74 to +43, respectively. The correlation obtained was 0.988 with a similarity of 97.9%. Between laboratory variation data was very good with %CV below 10%.
The introduction of dry reagents permits the elimination of cold-chain transportation and the on-site refrigerated storage without compromise to assay quality. The substitution of dry reagents facilitates easier supply management practice that will assure wider access to quality HIV treatment.
改进替代 CD4 细胞计数方法的努力对于加速资源有限地区的 HIV 抗逆转录病毒治疗的实施至关重要。用干格式试剂替代液体试剂，消除冷链运输和冷藏储存，有助于提高效率的供应管理解决方案，特别是对于偏远地区的实验室。ReaMetrix 开发了与 FACSCount 系统兼容的干格式试剂试剂盒，该系统是一种专用于 T 细胞亚群计数的流式细胞仪，广泛应用于资源有限的环境。设计了一项双地点协作研究，以比较使用新的干格式 ReaMetrix 试剂和原始 BD 生物科学液体试剂的 T 细胞亚群。
共分析了 167 份用 Rea T Count（ReaMetrix）和 FACSCount（BD Biosciences）试剂制备的 HIV 阳性样本，使用 FACSCount 系统。为了比较这两种方法，应用了 Bland-Altman、Pollock、Scott %相似性和相关系数统计分析。Immuno-Trol 用作实验室间和实验室内变异的分析处理控制和质量指标。
Rea T Count 和 FACSCount 试剂之间 CD4 T 细胞测量的平均偏差和协议范围分别为-16 个细胞/微升（-4.6%）和-74 至+43。获得的相关性为 0.988，相似性为 97.9%。实验室间变异数据非常好，CV%低于 10%。
干试剂的引入允许消除冷链运输和现场冷藏储存，而不影响检测质量。干试剂的替代简化了供应管理实践，将确保更广泛地获得高质量的 HIV 治疗。
