Rhodes Daniel, Carcelain Guislaine, Keeney Mike, Parizot Christophe, Benjamins Dominika, Genesta Laurine, Zhang Jin, Rohrbach Justin, Lawrie Denise, Glencross Deborah K
Clinical Affairs, Beckman Coulter Immunotech, Marseille, France.
Immunology Laboratory, Assistance Publique Hopitaux De Paris, Paris, France.
Afr J Lab Med. 2019 Dec 5;8(1):804. doi: 10.4102/ajlm.v8i1.804. eCollection 2019.
Flow cytometry has been the approach of choice for enumerating and documenting CD4-cell decline in HIV monitoring. Beckman Coulter has developed a single platform test for CD4+ T-cell lymphocyte count and percentage using PanLeucogating (PLG) technology on the automated AQUIOS flow cytometer (AQUIOS PLG).
This study compared the performance of AQUIOS PLG with the Flowcare PLG method and performed a reference interval for comparison with those previously published.
The study was conducted between November 2014 and March 2015 at 5 different centres located in Canada; Paris, France; Lyon, France; the United States; and South Africa. Two-hundred and forty samples from HIV-positive adult and paediatric patients were used to compare the performances of AQUIOS PLG and Flowcare PLG on a FC500 flow cytometer (Flowcare PLG) in determining CD4+ absolute count and percentage. A reference interval was determined using 155 samples from healthy, non-HIV adults. Workflow was investigated testing 440 samples over 5 days.
Mean absolute and relative count bias between AQUIOS PLG and Flowcare PLG was -41 cells/L and -7.8%. Upward and downward misclassification at various CD4 thresholds was ≤ 2.4% and ≤ 11.1%. The 95% reference interval (2.5th - 97.5th) for the CD4+ count was 453-1534 cells/L and the percentage was 30.5% - 63.4%. The workflow showed an average number of HIV samples tested as 17.5 per hour or 122.5 per 8-hour shift for one technician, including passing quality controls.
The AQUIOS PLG merges desirable aspects from conventional flow cytometer systems (high throughput, precision and accuracy, external quality assessment compatibility) with low technical operating skill requirements for automated, single platform systems.
在HIV监测中，流式细胞术一直是计数和记录CD4细胞减少情况的首选方法。贝克曼库尔特公司已在自动化AQUIOS流式细胞仪（AQUIOS PLG）上开发了一种使用全白细胞门控（PLG）技术的CD4 + T淋巴细胞计数和百分比的单平台检测方法。
本研究比较了AQUIOS PLG与Flowcare PLG方法的性能，并进行了参考区间的测定，以便与先前发表的结果进行比较。
该研究于2014年11月至2015年3月在加拿大、法国巴黎、法国里昂、美国和南非的5个不同中心进行。使用来自HIV阳性成人和儿科患者的240份样本，在FC500流式细胞仪（Flowcare PLG）上比较AQUIOS PLG和Flowcare PLG在测定CD4 +绝对计数和百分比方面的性能。使用来自健康非HIV成人的155份样本确定参考区间。在5天内对440份样本进行检测以研究工作流程。
AQUIOS PLG与Flowcare PLG之间的平均绝对计数和相对计数偏差分别为-41个细胞/升和-7.8%。在不同CD4阈值下的向上和向下错误分类分别≤2.4%和≤11.1%。CD4 +计数的95%参考区间（第2.5百分位数 - 第97.5百分位数）为453 - 1534个细胞/升，百分比为30.5% - 63.4%。工作流程显示，一名技术人员每小时平均检测17.5份HIV样本，或每8小时轮班检测122.5份，包括通过质量控制。
AQUIOS PLG将传统流式细胞仪系统的理想特性（高通量、精密度和准确性、外部质量评估兼容性）与自动化单平台系统对技术操作技能要求较低的特点相结合。
