Evaluation of an automated platform for the detection of HEV RNA in plasma and stool

IF 2.2 4区医学 Q3 BIOCHEMICAL RESEARCH METHODS Journal of virological methods Pub Date : 2024-04-03 DOI:10.1016/j.jviromet.2024.114920

Pauline Sottil , Sébastien Lhomme , Karine Saune , Soheil El Hayani , Kévin Oliveira-Mendes , Jean-Marie Peron , 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 HEV RNA platform for detecting HEV RNA.

Methods and results

Clinical performance was determined by testing 81 plasma samples and 10 fecal samples manually quantified previously with the Realstar RT-PCR assay using the Magnapure instrument for extraction. The assays were concordant for 79/81 plasma samples (97.5%) and 10/10 (100%) fecal samples. The two plasma samples that tested negative with the Altostar assay had a very low HEV RNA concentration (1.6 and 1.4 log₁₀ IU/ml). Quantitative results obtained with the automated platform and the manual workflow were highly correlated (ρ= 0.98, p<0.01). The intra-run and inter-run standard deviation were 0.09 IU/ml and 0.13 IU/ml respectively. The assay was linear from 2 to 6 log IU/ml. The limit of detection determined by Probit analysis with the WHO HEV RNA standard was 7.6 [95% CI: 4.4–52.5] IU/ml.

Conclusions

The Altostar platform enables highly accurate testing for the detection of HEV RNA in stool and the quantification of HEV RNA in plasma. This allowed us to shorten turnaround times and to save time for the technical staff.

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评估血浆和粪便中 HEV RNA 的自动检测平台

方法和结果通过检测 81 份血浆样本和 10 份粪便样本，确定了它们的临床性能。79/81 份血浆样本（97.5%）和 10/10 份粪便样本（100%）的检测结果一致。Altostar 检测法检测阴性的两个血浆样本的 HEV RNA 浓度非常低（1.6 和 1.4 log10 IU/ml）。自动平台和手动工作流程的定量结果高度相关（ρ= 0.98，p<0.01）。运行内和运行间标准偏差分别为 0.09 IU/ml 和 0.13 IU/ml。检测结果在 2 至 6 log IU/ml 之间呈线性关系。结论 Altostar 平台可实现高精度检测粪便中的 HEV RNA 和定量血浆中的 HEV RNA。这让我们缩短了周转时间，节省了技术人员的时间。

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 virological methods 医学-病毒学

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.