Evaluation and comparison of three high throughput assays (Alinity m CMV, Aptima CMV Quant and cobas CMV) for quantifying CMV DNA in plasma samples

IF 2.2 4区 医学 Q3 BIOCHEMICAL RESEARCH METHODS
Jodie D’Costa, Doris Chibo, Katherine Soloczynskyj, Mitchell Batty, Rizmina Sameer, Elaine Lee, Thomas Tran, Dimi Mavroulis, Megan Gooey, Eloise Williams, Kathy Jackson
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引用次数: 0

Abstract

Background

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.

Methods

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.

Results

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 %).

Conclusions

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.
评估和比较用于定量血浆样本中 CMV DNA 的三种高通量检测方法(Alinity m CMV、Aptima CMV Quant 和 cobas CMV)。
背景:巨细胞病毒(CMV)可导致免疫功能低下者(包括实体器官移植和造血干细胞移植受者)出现无症状的 CMV 综合征或组织侵袭性 CMV 疾病。在这些人群中,监测 CMV 病毒载量至关重要,可评估疾病风险和对抗病毒治疗的反应。目前已有用于 CMV 定量的高通量商业检测方法,但这些检测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对罗氏 cobas 6800、雅培 Alinity m 和 Hologic Panther 平台的 CMV 定量检测进行了评估:使用核酸扩增技术(cobas 和 Alinity m)或 Hologic CMV QC Calibrator 6 (Aptima)进行分析评估。三个平台同时检测了 136 份临床血浆样本:结果:每种检测方法的线性范围在 98.6% 到 99.96% 之间,精密度和定量限符合预期,不同平台之间的差异很小。对 136 份临床血浆样本进行了评估,发现每种检测方法之间的一致性相似。Aptima Quant 和 Alinity m 检测法之间的正相关性最高(95.6%,95% CI 89-98.6%),Aptima Quant 和 cobas 检测法之间的正相关性最低(94.1%,87.4-97.5%):结论:在定量检测 CMV 时,所有检测方法的灵敏度和准确度都很高,所有 3 种检测方法在监测患者血浆中 CMV 病毒载量方面的性能相当。
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来源期刊
CiteScore
5.80
自引率
0.00%
发文量
209
审稿时长
41 days
期刊介绍: The Journal of Virological Methods focuses on original, high quality research papers that describe novel and comprehensively tested methods which enhance human, animal, plant, bacterial or environmental virology and prions research and discovery. The methods may include, but not limited to, the study of: Viral components and morphology- Virus isolation, propagation and development of viral vectors- Viral pathogenesis, oncogenesis, vaccines and antivirals- Virus replication, host-pathogen interactions and responses- Virus transmission, prevention, control and treatment- Viral metagenomics and virome- Virus ecology, adaption and evolution- Applied virology such as nanotechnology- Viral diagnosis with novelty and comprehensive evaluation. We seek articles, systematic reviews, meta-analyses and laboratory protocols that include comprehensive technical details with statistical confirmations that provide validations against current best practice, international standards or quality assurance programs and which advance knowledge in virology leading to improved medical, veterinary or agricultural practices and management.
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