Performance of a commercial assay for detecting JC Polyomavirus DNA in human samples.

IF 3.4 3区医学 Q2 VIROLOGY

Journal of Clinical Virology Pub Date : 2025-10-01 Epub Date: 2025-08-05 DOI:10.1016/j.jcv.2025.105849

Sébastien Lhomme, Isabelle Da Silva, Oriane Cabanel, Estelle Raguin, Guillaume Martin-Blondel, Nassim Kamar, Jacques Izopet, Florence Abravanel

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引用次数: 0

Abstract

Introduction: We evaluated the performance of the automated AltoStar JCV PCR platform for detecting and quantifying JC Polyomavirus (JCPyV) DNA in samples including urine, plasma and cerebrospinal fluid.

Methods and results: Using the NIBSC JCPyV DNA standard, the assay was linear from 1 to 6 log IU/mL standard and the limit of detection determined by Probit analysis corresponded to 9.3 [95 % CI: 7.0-16.5] IU/mL. Specificity was accessed by testing urines containing a high concentration of BK Polyomavirus; none tested positive for JCPyV. The intra-run and inter-run standard deviations were 0.02 IU/mL and 0.35 IU/mL, respectively. Lastly, clinical performance was determined by testing 45 samples quantified previously with a laboratory-developed test (LDT). The assays were concordant for 42/45 samples. One of the 3 samples that tested negative with the AltoStar assay had a low JCpyV DNA concentration. We were unable to re-test the 3 negative samples due to insufficient volume. A conservation problem could not be ruled out for the 3 samples with discordant results.

Conclusions: The AltoStar platform enables highly accurate testing for the detection and quantification of JCPyV DNA with very low limit of detection. This allowed us to shorten turnaround times and save time for technical staff.

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用于检测人类样本中JC多瘤病毒DNA的商业试验的性能。

简介：我们评估了自动化AltoStar JCV PCR平台检测和定量尿样、血浆和脑脊液中JC多瘤病毒（JCPyV） DNA的性能。方法与结果：采用NIBSC JCPyV DNA标准，在1 ~ 6 log IU/mL标准范围内呈线性关系，Probit分析的检出限为9.3 [95% CI: 7.0 ~ 16.5] IU/mL。通过检测含有高浓度BK多瘤病毒的尿液获得特异性；没有人对JCPyV呈阳性反应。组内和组间标准差分别为0.02 IU/mL和0.35 IU/mL。最后，通过测试45个样品来确定临床表现，这些样品之前是用实验室开发的测试（LDT）量化的。45份样品中有42份检测结果一致。AltoStar检测阴性的3个样本中有一个jpyv DNA浓度较低。由于容量不足，我们无法重新测试3个阴性样品。结果不一致的3个样品不能排除守恒问题。结论：AltoStar平台对JCPyV DNA的检测和定量具有较高的准确性，检测限极低。这使我们能够缩短周转时间，节省技术人员的时间。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Journal of Clinical Virology 医学-病毒学

CiteScore

22.70

自引率

1.10%

发文量

149

审稿时长

24 days

期刊介绍： The Journal of Clinical Virology, an esteemed international publication, serves as the official journal for both the Pan American Society for Clinical Virology and The European Society for Clinical Virology. Dedicated to advancing the understanding of human virology in clinical settings, the Journal of Clinical Virology focuses on disseminating research papers and reviews pertaining to the clinical aspects of virology. Its scope encompasses articles discussing diagnostic methodologies and virus-induced clinical conditions, with an emphasis on practicality and relevance to clinical practice. The journal publishes on topics that include: • new diagnostic technologies • nucleic acid amplification and serologic testing • targeted and metagenomic next-generation sequencing • emerging pandemic viral threats • respiratory viruses • transplant viruses • chronic viral infections • cancer-associated viruses • gastrointestinal viruses • central nervous system viruses • one health (excludes animal health)