Department of Laboratory Medicine, Hallym University Sacred Heart Hospital, Anyang, Republic of Korea.
Department of Laboratory Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea.
J Clin Virol. 2021 May;138:104816. doi: 10.1016/j.jcv.2021.104816. Epub 2021 Mar 31.
Cytomegalovirus (CMV) nucleic acid amplification testing is important for CMV infection diagnosis and management. CMV DNA is found in plasma and various other fluids, including urine. If CMV can be reliably detected in urine, it may be considered a non-invasive alternative to blood tests. The cobas 6800 system (Roche Diagnostics, Mannheim, Germany) is a Food and Drug Administration-approved testing platform for measuring CMV DNA in plasma.
To evaluate the analytical performance of the cobas 6800 system and compare the clinical feasibility of CMV detection in plasma and urine samples.
Imprecision, linearity, limit of quantitation (LOQ), and cross-reactivity of the cobas 6800 system were assessed, and reference interval verification was performed. Plasma CMV DNA quantification was compared to CMV DNA values in urine samples obtained from 129 pediatric patients (<18 years of age) from March 2020 to May 2020 at a tertiary hospital.
The assay precision was within the acceptable range. Linearity was observed within the tested concentration range (2.36-6.33 log IU/mL) with a coefficient of determination of 0.9972. The LOQ was 34.5 IU/mL. The assay did not show cross-reactivity with 15 other viruses. Plasma and urine detection results were stratified into three categories: negative, <LOQ, and positive to analyze the degree of agreement with the results. The quadratic weighted kappa value was 0.623 (P = 0.000), showing substantial concurrence.
The cobas 6800 system offers good sensitivity, precision, and linearity and is suitable for monitoring CMV viral loads in the plasma and urine samples.
巨细胞病毒 (CMV) 核酸扩增检测对于 CMV 感染的诊断和管理很重要。CMV DNA 存在于血浆和各种其他体液中，包括尿液。如果可以在尿液中可靠地检测到 CMV，那么它可能被认为是血液检测的一种非侵入性替代方法。 cobas 6800 系统（罗氏诊断公司，德国曼海姆）是一种经美国食品和药物管理局批准的用于测量血浆中 CMV DNA 的检测平台。
评估 cobas 6800 系统的分析性能，并比较血浆和尿液样本中 CMV 检测的临床可行性。
评估了 cobas 6800 系统的不精密度、线性、定量下限 (LOQ) 和交叉反应性，并进行了参考区间验证。比较了 2020 年 3 月至 5 月在一家三级医院采集的 129 名儿科患者（<18 岁）的血浆 CMV DNA 定量与尿液样本中的 CMV DNA 值。
该检测的精密度在可接受范围内。在测试浓度范围内（2.36-6.33 log IU/mL）观察到线性，决定系数为 0.9972。LOQ 为 34.5 IU/mL。该检测未显示与其他 15 种病毒的交叉反应。将血浆和尿液检测结果分为三类：阴性、<LOQ 和阳性，以分析与结果的一致性程度。二次加权 Kappa 值为 0.623（P = 0.000），表明存在实质性一致性。
cobas 6800 系统具有良好的灵敏度、精密度和线性度，适用于监测血浆和尿液样本中的 CMV 病毒载量。
