【摘要】 目的 评估国产全自动T淋巴细胞前处理系统（A系统）对全血前处理样本制备的技术性能及其与进口设备的等效性。方法 采用配对实验设计，收集2022年2-8月泉州市HIV-1感染者EDTA抗凝全血样本。通过双盲平行处理流程，分别采用BD FACS Sample Prep AssistantⅢ系统（B系统）和A系统完成样本制备，采用BD FACS CantoⅡ流式细胞仪检测CD45、CD3、CD4和CD8细胞绝对值计数和百分比。数据分析采用：Shapiro-Wilk正态性检验；配对t检验（正态数据）或Wilcoxon符号秩检验（非正态数据）；Bland-Altman分析（CD4细胞预设实验允许误差±50个/μL）和组内相关系数（ICC）评估系统间一致性。结果 47份样本中，男性占比87.23%(41人)，20～<60岁占89.36%(42人)。检测结果显示：A系统各指标检测结果与B系统在CD45细胞（Z=-2.55, P=0.01）、CD3细胞（Z=-2.42, P=0.02）、CD4细胞（t=2.70, P=0.01）和CD8细胞（Z=-3.26, P=0.001）差异有统计学意义；Bland-Altman分析显示：A系统各指标检测结果普遍高于B系统，CD45细胞检出3例异常值（6.38%）;CD3细胞在高值区（>1 000个/μL）存在系统误差；CD4细胞95%LoA(-86.5～+144.5个/μL)跨越临床允许阈值；CD8细胞高值区（>1 500个/μL）存在显著正向偏移；ICC分析表明系统间一致性水平为：CD3细胞（ICC=0.98）>CD8细胞（ICC=0.97）>CD45细胞（ICC=0.96）>CD4细胞（ICC=0.94）（均P<0.001）。结论 国产A系统在全血前处理样本制备性能与B系统具有良好等效性，但存在系统性正偏差，可能影响CD4细胞绝对值计数作为HIV-1免疫分期准确性，建议优化样本处理程序纠正检测结果偏差。更多还原

【Abstract】 Objective To evaluate the technical performance and equivalence of a domestic fully automated T-lymphocyte preprocessing system (System A) for whole blood sample preparation compared to its imported counterpart.Methods A paired experimental design was used.Ethylenediaminetetraacetic acid (EDTA)-anticoagulated whole blood samples from human immunodeficiency virus type 1 (HIV-1)-infected individuals in Quanzhou,China,were randomly selected from February 2022 to August 2022.Using a double-blind parallel processing protocol,samples were prepared with both BD FACS Sample Prep Assistant III (System B) and System A.Absolute counts and percentages of CD45~+leukocytes and CD3~+,CD4~+,and CD8~+T-lymphocytes were detected using a BD FACS Canto II flow cytometer.Statistical analyses included:Shapiro-Wilk normality testing,paired t-tests (normally distributed data) or Wilcoxon signed-rank tests(non-parametric data),Bland-Altman analysis (predefined allowable error for CD4~+cells:±50 cells/μL),and intraclass correlation coefficients (ICC) for inter-system consistency evaluation.Results Among the 47 samples,males constituted 87.23%,and young and middle-aged adults (20–60years) accounted for 89.36%.System A demonstrated statistically significant higher measurements across all parameters compared to System B (CD45~+:Z=-2.55,P=0.01;CD3~+:Z=-2.42,P=0.02;CD4~+:t=2.70,P=0.01;CD8~+:Z=-3.26,P=0.001).Bland-Altman analysis showed that the detection results of all indicators in system A were generally higher than those in system B: three CD45~+ outliers(6.38%); systematic bias in CD3~+ high-concentration regions(>1 000 cells/μL); CD4~+ 95% limits of agreement(Lo A:-86.5 to ~+144.5 cells/μL) exceeding clinical tolerance thresholds; and significant positive bias in CD8~+ highconcentration regions(>1, 500 cells/μL). The ICC analysis indicated excellent intersystem consistency across all parameters: CD3~+(ICC=0.98), CD8~+(ICC=0.97), CD45~+(ICC=0.96), and CD4~+(ICC=0.94)(all P<0.001). Conclusions The domestic System A exhibits favorable technical equivalence to System B in whole blood preprocessing; however, its systematic positive bias may compromise the accuracy of CD4~+ absolute counts for HIV-1 immunological staging. Standardized calibration protocols are recommended to optimize the clinical applicability.更多还原