Evaluation of the AltoStar AM16 system for the quantitation of AdV, CMV and HHV-6 DNA from clinical specimens

IF 2.2 4区 医学 Q3 BIOCHEMICAL RESEARCH METHODS
H. Fenaux , R. Rafek , Thouard I , G. Decombe , C. Vieux-Combe , C. Hottelet , Portet Sulla V , L. Mouna
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引用次数: 0

Abstract

The vulnerability of immunocompromised patients to common or opportunistic viral infections is particularly high. The quantitation of viral load in clinical specimens is important for the diagnosis and management of the infection and reactivation in this patient population, particularly transplant recipients. As the new regulation “IVDR” regarding in vitro diagnosis methods is about to come into effect in France, diagnostic laboratories have to implement methods and systems compatible with this new regulation. Technical performance of the AltoStar® Adenovirus (AdV), Cytomegalovirus (CMV) and human Herpesvirus-6 (HHV-6) DNA PCR Kits 1.5 was assessed on the AltoStar Automation system AM16 using reference kits in 146 clinical samples. Overall agreement in clinical specimens was 87.5 % (28/32), 96.8 % (62/64), 100 % (22/22), 100 % (28/28) and 92.8 % (26/28) for AdV, CMV (WB samples and other matrices), HHV-6 A&B respectively. Quantitative results were highly correlated and estimated to be equivalent within a 0.057–0.648 log-amount difference.We found that altona kits on The AltoStar AM16 system are suitable for clinical monitoring of AdV, CMV and HHV-6 in immunocompromised hosts.

评估 AltoStar AM16 系统对临床样本中 AdV、CMV 和 HHV-6 DNA 的定量。
免疫力低下的病人特别容易受到普通病毒或机会性病毒感染。临床标本中病毒载量的定量对于诊断和管理这类患者,尤其是移植受者的感染和再激活非常重要。由于有关体外诊断方法的新法规 "IVDR "即将在法国生效,诊断实验室必须采用与新法规相适应的方法和系统。在 AltoStar 自动化系统 AM16 上使用参考试剂盒对 146 份临床样本进行了评估,结果显示 AltoStar® 腺病毒 (AdV)、巨细胞病毒 (CMV) 和人类疱疹病毒-6 (HHV-6) DNA PCR 试剂盒 1.5 的技术性能良好。在临床样本中,AdV、CMV(WB 样本和其他基质)、HHV-6 A&B 的总体一致性分别为 87.5%(28/32)、96.8%(62/64)、100%(22/22)、100%(28/28)和 92.8%(26/28)。我们发现 AltoStar AM16 系统上的 altona 试剂盒适用于免疫受损宿主中 AdV、CMV 和 HHV-6 的临床监测。
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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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