Thakar Madhuri, Angira Francis, Pattanapanyasat Kovit, Wu Alan H B, O'Gorman Maurice, Zeng Hui, Qu Chenxue, Mahajan Bharati, Sukapirom Kasama, Chen Danying, Hao Yu, Gong Yan, Indig Monika De Arruda, Graminske Sharon, Orta Diana, d'Empaire Nicole, Lu Beverly, Omana-Zapata Imelda, Zeh Clement
National AIDS Research Institute, Pune, India.
Kenya Medical Research Institute/US CDC Research and Public Health Collaboration, Kisumu, Kenya.
Open AIDS J. 2017 Oct 24;11:76-90. doi: 10.2174/1874613601711010076. eCollection 2017.
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.
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.
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 R ≥0.96; Hb slopes were ≥1.00 and R ≥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.
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.
BD FACSPresto系统使用毛细血管血和静脉血在约25分钟内测量CD4绝对计数（CD4）、淋巴细胞中CD4百分比（%CD4）和血红蛋白（Hb）。在资源有限的环境中，CD4细胞计数用于便携式CD4计数器来管理艾滋病毒/艾滋病患者。使用来自五个国家七个临床实验室的毛细血管血和静脉血样本进行了方法比较。在四个地点评估了BD FACSPresto系统在实验室之间、仪器/操作人员、试剂盒批次以及批内的变异性。
在获得批准的自愿同意下采集样本。使用金标准BD FACSCalibur系统检测乙二胺四乙酸（EDTA）抗凝的静脉血样本中的CD4和CD4 T细胞百分比，使用Sysmex KX - 21N分析仪检测Hb。在BD FACSPresto系统上检测静脉血和毛细血管血样本。对匹配数据进行偏差分析（Deming线性回归和Bland - Altman方法）以及临床决策点周围的一致性分析。估计每个地点、仪器/操作人员、试剂盒批次以及批间的变异系数。
在方法比较中，720个样本中有93%来自艾滋病毒阳性患者，7%来自艾滋病毒阴性或正常受试者。CD4和CD4 T细胞百分比的静脉血和毛细血管血结果的斜率在0.96 - 1.05之间，相关系数R≥0.96；Hb斜率≥1.00，R≥0.89。不同地点/操作人员之间的变异性对于CD4计数变异系数%CV<5.8%，对于%CD4<1.9%，对于Hb<3.2%。仪器/试剂盒批次间的总变异系数%CV<7.7%。
与金标准方法相比，BD FACSPresto系统提供准确、可靠、精确的CD4/%CD4/Hb结果，无论采用静脉血还是毛细血管血采样。数据显示BD FACSPresto、BD FACSCalibur和Sysmex系统之间具有良好的一致性。
