Manasa Justen, Musabaike Hazvineyi, Masimirembwa Collen, Burke Eileen, Luthy Ruedi, Mudzori James
Molecular Diagnostics Unit, African Institute of Biomedical Science and Technology, P.O. Box 2294, Harare, Zimbabwe.
Clin Vaccine Immunol. 2007 Mar;14(3):293-8. doi: 10.1128/CVI.00416-06. Epub 2007 Jan 31.
A single-platform volumetric flow cytometer, the Partec Cyflow SL_3, was evaluated against a BD FACSCalibur/Sysmex XT1800i dual platform for measuring CD4(+) lymphocytes, total lymphocytes, and the percentage of CD4 lymphocytes in whole-blood samples for monitoring the immune systems of human immunodeficiency virus (HIV)/AIDS patients. Statistical analyses for precision, correlation, and agreement were performed. Coefficients of variation (CV) of 5.8, 4.6, and 3.9% were obtained for low, medium, and high CD4(+) cell counts, respectively, using the SL_3, and CV of 3.7, 4.0, and 0.94 were obtained for the same categories, using the BD FACSCalibur. Significant correlations (P < 0.005) between the two assays for CD4 counts, total lymphocyte counts, and percentages of CD4 were obtained, with correlation coefficients of 0.99, 0.96, and 0.99, respectively (n = 229). Using the Bland-Altman plot, mean biases of -18 cell/microl (95% confidence interval (CI); -91 to 54 cells/microl), -0.8% (95% CI; -3.6 to 2%), and -36.8 cells/microl (95% CI; -477 to 404 cells/microl) were obtained for comparisons of CD4 counts, percentages of CD4 cells, and total lymphocyte counts, respectively. The effects of the age of the samples on the three parameters were also analyzed by comparing results from the same samples analyzed at 6, 24, and 48 h after collection. The correlation coefficients for comparisons among different time points for the same machine and among all the time points for the two different machines were greater than 0.90. These data showed that the Partec Cyflow SL_3 assay is comparable to the BD FACSCalibur/Sysmex XT1800i dual-platform method for measuring the amount of CD4(+) cells and total lymphocytes and the percentages of CD4 cells in blood samples for the purpose of monitoring HIV/AIDS patients.
对一款单平台体积流式细胞仪Partec Cyflow SL_3进行了评估,将其与BD FACSCalibur/Sysmex XT1800i双平台用于测量全血样本中的CD4(+)淋巴细胞、总淋巴细胞以及CD4淋巴细胞百分比,以监测人类免疫缺陷病毒(HIV)/艾滋病患者的免疫系统。进行了精密度、相关性和一致性的统计分析。使用SL_3,低、中、高CD4(+)细胞计数的变异系数(CV)分别为5.8%、4.6%和3.9%,使用BD FACSCalibur,相同类别的CV分别为3.7%、4.0%和0.94%。两种检测方法在CD4计数、总淋巴细胞计数和CD4百分比之间获得了显著相关性(P < 0.005),相关系数分别为0.99、0.96和0.99(n = 229)。使用Bland-Altman图,CD4计数、CD4细胞百分比和总淋巴细胞计数比较的平均偏差分别为-18个细胞/微升(95%置信区间(CI);-91至54个细胞/微升)、-0.8%(95%CI;-3.6至2%)和-36.8个细胞/微升(95%CI;-477至404个细胞/微升)。还通过比较采集后6小时、24小时和48小时分析的同一样本的结果,分析了样本保存时间对这三个参数的影响。同一台机器不同时间点之间以及两种不同机器所有时间点之间比较的相关系数均大于0.90。这些数据表明,Partec Cyflow SL_3检测方法在测量血液样本中CD4(+)细胞数量、总淋巴细胞数量以及CD4细胞百分比方面与BD FACSCalibur/Sysmex XT1800i双平台方法相当,可用于监测HIV/艾滋病患者。