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评估Alinity m巨细胞病毒检测法在非血浆样本中检测和定量巨细胞病毒DNA的能力。

Evaluation of the Alinity m CMV assay for detecting and quantifying cytomegalovirus DNA in non-plasma samples.

作者信息

Scohy Anaïs, Argudín Maria A, Kabera Florence, Olive Nathalie, Kabamba Mukadi Benoît

机构信息

Department of Laboratory Medicine, Cliniques universitaires Saint-Luc, Brussels, Belgium; Institute of Experimental and Clinical Research (IREC), Université Catholique de Louvain, Brussels, Belgium.

Department of Laboratory Medicine, Cliniques universitaires Saint-Luc, Brussels, Belgium.

出版信息

J Virol Methods. 2025 Feb;332:115069. doi: 10.1016/j.jviromet.2024.115069. Epub 2024 Nov 19.

DOI:10.1016/j.jviromet.2024.115069
PMID:39571937
Abstract

CMV infection remains a well-recognized threat in immunocompromised patients and is a major cause of congenital infection. If plasma and whole blood are routinely used as clinical samples for detection of CMV infection and disease, CMV laboratory testing in non-blood samples is becoming more and more relevant to support the diagnosis, prognosis and management of CMV infection. Accurate CMV viral load assessment in various body fluids is therefore essential. We evaluated the performance of the Alinity m CMV assay for detecting and quantifying CMV in plasma, amniotic fluid, bronchoalveolar lavage, cerebrospinal fluid, saliva and urine. Using a commercially available CMV reference panel and CMV culture supernatant, we assessed the linearity and accuracy of the Alinity m CMV assay across the different sample types. Excellent linear correlations (r values > 0.98) and a good accuracy (bias < ± 0.50 Log IU/mL and SD < 0.23) were observed. In conclusion, the Alinity m CMV assay is suitable to detect and quantify CMV DNA in plasma but also in all non-plasma samples tested. Random and continuous access capabilities of the Alinity m enable rapid and efficient laboratory detection and quantification of CMV DNA.

摘要

巨细胞病毒(CMV)感染在免疫功能低下的患者中仍然是一个公认的威胁,并且是先天性感染的主要原因。如果血浆和全血被常规用作检测CMV感染和疾病的临床样本,那么非血液样本中的CMV实验室检测对于支持CMV感染的诊断、预后和管理变得越来越重要。因此,准确评估各种体液中的CMV病毒载量至关重要。我们评估了Alinity m CMV检测法在检测和定量血浆、羊水、支气管肺泡灌洗液、脑脊液、唾液和尿液中的CMV方面的性能。使用市售的CMV参考品和CMV培养上清液,我们评估了Alinity m CMV检测法在不同样本类型中的线性和准确性。观察到了良好的线性相关性(r值>0.98)和良好的准确性(偏差<±0.50 Log IU/mL且标准差<0.23)。总之,Alinity m CMV检测法适用于检测和定量血浆以及所有测试的非血浆样本中的CMV DNA。Alinity m的随机和连续进样能力能够实现CMV DNA的快速、高效实验室检测和定量。

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Evaluation of the Alinity m CMV assay for detecting and quantifying cytomegalovirus DNA in non-plasma samples.评估Alinity m巨细胞病毒检测法在非血浆样本中检测和定量巨细胞病毒DNA的能力。
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