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首页> 外文期刊>The open AIDS journal >CD4 Lymphocyte Enumeration and Hemoglobin Assessment Aid for Priority Decisions: A Multisite Evaluation of the BD FACSPresto? System
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CD4 Lymphocyte Enumeration and Hemoglobin Assessment Aid for Priority Decisions: A Multisite Evaluation of the BD FACSPresto? System

机译：CD4淋巴细胞计数和血红蛋白评估有助于做出优先决策：BD FACSPresto的多点评估系统

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Background:The BD FACSPresto? system uses capillary and venous blood to measure CD4 absolute counts (CD4), %CD4 in lymphocytes, and hemoglobin (Hb) in approximately 25 minutes. CD4 cell count is used with portable CD4 counters in resource-limited settings to manage HIV/AIDS patients. A method comparison was performed using capillary and venous samples from seven clinical laboratories in five countries. The BD FACSPresto system was assessed for variability between laboratory, instrument/operators, cartridge lots and within-run at four sites.Methods:Samples were collected under approved voluntary consent. EDTA-anticoagulated venous samples were tested for CD4 and %CD4 T cells using the gold-standard BD FACSCalibur? system, and for Hb, using the Sysmex? KX-21N? analyzer. Venous and capillary samples were tested on the BD FACSPresto system. Matched data was analyzed for bias (Deming linear regression and Bland-Altman methods), and for concordance around the clinical decision point. The coefficient of variation was estimated per site, instrument/operator, cartridge-lot and between-runs.Results:For method comparison, 93% of the 720 samples were from HIV-positive and 7% from HIV-negative or normal subjects. CD4 and %CD4 T cells venous and capillary results gave slopes within 0.96–1.05 and R2 ≥0.96; Hb slopes were ≥1.00 and R2 ≥0.89. Variability across sites/operators gave %CV &5.8% for CD4 counts, &1.9% for %CD4 and &3.2% for Hb. The total %CV was &7.7% across instrument/cartridge lot.Conclusion:The BD FACSPresto system provides accurate, reliable, precise CD4/%CD4/Hb results compared to gold-standard methods, irrespective of venous or capillary blood sampling. The data showed good agreement between the BD FACSPresto, BD FACSCalibur and Sysmex systems.
机译：背景：BD FACSPresto？系统使用毛细血管和静脉血在大约25分钟内测量CD4绝对计数（CD4），淋巴细胞中的％CD4和血红蛋白（Hb）。在资源有限的情况下，CD4细胞计数与便携式CD4计数器一起使用可管理HIV / AIDS患者。使用来自五个国家的七个临床实验室的毛细管和静脉样本进行了方法比较。评估了BD FACSPresto系统在实验室，仪器/操作员，试剂盒批次以及四个地点的运行内之间的变异性。方法：样品在获得批准的自愿同意下收集。使用黄金标准BD FACSCalibur？测试EDTA抗凝静脉样品的CD4和％CD4 T细胞。系统，对于Hb，使用Sysmex？ KX-21N？分析仪。在BD FACSPresto系统上测试静脉和毛细血管样品。分析匹配数据的偏倚（Deming线性回归和Bland-Altman方法），以及围绕临床决策点的一致性。结果：为了进行方法比较，在720个样本中，有93％来自HIV阳性，而7％来自HIV阴性或正常个体，用于方法比较。 CD4和％CD4 T细胞的静脉和毛细血管结果显示斜率在0.96-1.05之间，R2≥0.96; Hb斜率≥1.00，R2≥0.89。站点/运营商之间的差异使CD4计数的％CV≤5.8％，％CD4的＆ 1.9％和Hb的＆ 3.2％。整个仪器/盒批次中的总％CV ＜7.7％。结论：BD FACSPresto系统与黄金标准方法相比，提供准确，可靠，精确的CD4 /％CD4 / Hb结果，而无需进行静脉或毛细管血液采样。数据显示BD FACSPresto，BD FACSCalibur和Sysmex系统之间具有良好的一致性。

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