D'Costa Jodie, Chibo Doris, Soloczynskyj Katherine, Batty Mitchell, Sameer Rizmina, Lee Elaine, Tran Thomas, Mavroulis Dimi, Gooey Megan, Williams Eloise, Jackson Kathy
Victorian Infectious Diseases Reference Laboratory, Peter Doherty Institute for Infection and Immunity, 792 Elizabeth St, Melbourne 3000, Australia.
Victorian Infectious Diseases Reference Laboratory, Peter Doherty Institute for Infection and Immunity, 792 Elizabeth St, Melbourne 3000, Australia.
J Virol Methods. 2025 Feb;332:115068. doi: 10.1016/j.jviromet.2024.115068. Epub 2024 Nov 15.
Cytomegalovirus (CMV) can cause symptomatic CMV syndrome or tissue-invasive CMV disease in immunocompromised individuals, including solid-organ transplant and hematopoietic stem cell transplant recipients. In these populations, monitoring of CMV load is essential, assessing both risk of disease and response to antiviral therapy. High throughput commercial assays are currently available for CMV quantitation, but they are often evaluated independently, with few studies comparing these assays. This study evaluated CMV quantitative assays for use with the Roche cobas 6800, Abbott Alinity m and Hologic Panther platforms using stored patient plasma.
Analytical evaluation was performed using the 1st WHO international standard for human CMV for Nucleic Acid Amplification Techniques (cobas and Alinity m) or the Hologic CMV QC Calibrator 6 (Aptima). Parallel testing of 136 clinical plasma samples was performed across the three platforms.
Linearity for each assay ranged from 98.6 % to 99.96 % and precision and limit of quantitation were as expected with little variation between platforms. 136 clinical plasma samples were evaluated with similar agreement observed between each assay. The greatest positive agreement was between the Aptima Quant and Alinity m assays (95.6 %, 95 % CI 89-98.6 %) and the lowest between the Aptima Quant and cobas assays (94.1 %, 87.4-97.5 %).
All assays were sensitive and accurate when quantifying CMV, and performance across all 3 assays was comparable for monitoring CMV viral loads in patient plasma.
巨细胞病毒（CMV）可在免疫功能低下的个体中引起有症状的CMV综合征或组织侵袭性CMV疾病，包括实体器官移植和造血干细胞移植受者。在这些人群中，监测CMV载量至关重要，它可评估疾病风险和对抗病毒治疗的反应。目前有高通量商业检测方法可用于CMV定量，但这些方法通常是独立评估的，很少有研究对这些检测方法进行比较。本研究使用储存的患者血浆评估了用于罗氏cobas 6800、雅培Alinity m和Hologic Panther平台的CMV定量检测方法。
使用世界卫生组织第一版人类CMV核酸扩增技术国际标准品（用于cobas和Alinity m）或Hologic CMV QC校准品6（Aptima）进行分析评估。在三个平台上对136份临床血浆样本进行平行检测。
每种检测方法的线性范围为98.6%至99.96%，精密度和定量限符合预期，各平台之间差异不大。对136份临床血浆样本进行评估，各检测方法之间的一致性相似。Aptima Quant检测方法与Alinity m检测方法之间的阳性一致性最高（95.6%，95%可信区间89 - 98.6%），Aptima Quant检测方法与cobas检测方法之间的阳性一致性最低（94.1%，87.4 - 97.5%）。
在对CMV进行定量时，所有检测方法均灵敏且准确，在监测患者血浆中CMV病毒载量方面，所有三种检测方法的性能相当。
