【摘要】 目的 比较Cobas 5800与Cobas Ampli Prep/Cobas TaqMan(CAP/CTM)系统对HIV-1病毒载量检测的定量性能一致性及差异。方法 采用横断面研究方法，收集2024年7-12月泉州市各县（市、区）艾滋病定点医疗机构进行cART的HIV/AIDS患者的HIV-1病毒载量检测EDTA抗凝血样标本，随机抽取141份，离心分离血浆，通过双系统平行检测，应用配对Wilcoxon符号秩和检验分析检测结果差异，Bland-Altman图分析一致性界限（LoA）,PassingBablok回归探讨系统误差，并计算组内相关系数（ICC）评价方法间一致性。结果 两种检测系统检测结果均呈非正态性分布，经配对Wilcoxon符号秩和检验，差异无统计学意义（S=85.00,P>0.05）;Bland-Altman图分析显示算术平均值偏差为0.01 log10 copies/mL(95%LoA-1.24～1.26 log10 copies/mL),CAP/CTM的平均值略低于Cobas 5800，低病毒载量区间（<20 copies/mL）差异显著高于中高载量区间；Passing-Bablok回归显示斜率β=0.98，截距α=0.00，证实无显著比例误差和恒定误差（P>0.05）;ICC为0.93，显示两种检测系统检测结果的一致性极强（F=13.64,P<0.001），分类结果一致性显示两种检测系统检测结果在≥50 copies/mL的阈值下分类完全一致。结论 Cobas 5800与CAP/CTM系统在HIV-1病毒载量定量检测中具有等效性，但在临界检测下限（<20 copies/mL）区域存在差异，建议实验室解读低值结果时需结合临床背景综合分析或随访检测。更多还原

【Abstract】 Objective To compare the quantitative performance of the Cobas 5800 and Cobas AmpliPrep/Cobas TaqMan(CAP/CTM) systems for HIV-1 viral load detection. Methods A cross-sectional study was conducted to collect ethylenediaminetetraacetic acid-anticoagulated blood samples for HIV-1 viral load testing from human immunodeficiency virus(HIV)/acquired immune deficiency syndrome(AIDS) patients undergoing combination antiretroviral therapy(cART)in designated AIDS treatment institutions across the counties(cities and districts) of Quanzhou City from July to December 2024. In total, 141 samples were randomly selected. After centrifugation to separate the plasma, the samples were analyzed in parallel using a dual-system approach. Differences in the test results were analyzed using the paired Wilcoxon signed-rank test. The limits of agreement(LoA) were assessed using the Bland-Altman plot, and systematic errors were explored using Passing-Bablok regression. The interclass correlation coefficient(ICC) was calculated to evaluate the consistency between the two methods. Results The measurements from both systems exhibited non-normal distributions, and no statistically significant differences were observed using the paired Wilcoxon signed-rank test(S=85.00, P=0.78). Bland-Altman analysis revealed a mean bias of 0.01 log10 copies/mL(95% LoA:-1.24 to 1.26 log10copies/mL), with CAP/CTM yielding slightly lower values than Cobas 5800. Notably, the differences in the low viral load range(<20 copies/m L) were significantly greater than those in the medium-to-high viral load ranges. PassingBablok regression indicated no significant proportional or constant errors(slope β =0.98, intercept α =0.00, P>0.05). The ICC of 0.93 demonstrated excellent agreement between the two detection systems(F=13.64, P<0.001), and the categorical agreement analysis demonstrated complete concordance between the two detection systems at the high viral load threshold of ≥50 copies/m L. Conclusions The Cobas 5800 and CAP/CTM systems exhibited equivalent performance in quantifying HIV-1 viral loads. However, methodological discrepancies were observed near the lower limit of detection(<20 copies/m L). The clinical interpretation of low-level results should incorporate a comprehensive contextual analysis or follow-up detection.更多还原