使用 ELITe BeGenius® 系统对 EDTA 血浆上的腺病毒 ELITe MGB® 定量检测试剂盒进行性能评估

IF 4 3区医学 Q2 VIROLOGY

Journal of Clinical Virology Pub Date : 2024-08-24 DOI:10.1016/j.jcv.2024.105722

Edwin Fries, Tessa Kalmeijer, Lara Spaans, Martin Rakké, Rob Schuurman, Jolanda D F De Groot-Mijnes

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引用次数: 0

摘要

背景腺病毒感染是造血干细胞移植后发病和死亡的重要原因。通过实时定量 PCR 检测和监测 EDTA 血浆中的腺病毒是一种灵敏的工具，可用于识别和管理面临潜在致命感染风险的患者。p.A.）系统的分析和临床性能，并将该检测方法与实验室开发的定量实时 PCR 检测方法进行比较。研究设计通过检测世卫组织标准的系列稀释液确定腺病毒 ELITe MGB® 检测试剂盒的分析灵敏度。腺病毒血清型的检测使用 51 种血清型的面板进行评估。结果腺病毒 ELITe MGB® 检测试剂盒的分析灵敏度至少为 54 (1.7 Log) IU/mL，定量结果在 1.7 至 6.6 Log IU/mL 范围内与 WHO 标准（R2 = 0.9978；Pearson）高度相关。所有 51 种腺病毒血清型均被检测到。腺病毒 ELITe MGB® 检测试剂盒对 EDTA 血浆的临床特异性和灵敏度分别为 97.4 % 和 99.1 %。

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Performance evaluation of the quantitative assay Adenovirus ELITe MGB® Kit on EDTA-plasma, using the ELITe BeGenius® system

Background

Adenovirus infections constitute an important cause of morbidity and mortality after hematopoietic stem cell transplantation. Detection and monitoring of adenovirus in EDTA-plasma by real-time quantitative PCR is a sensitive tool for identification and management of patients at risk of a potentially fatal infection.

Objectives

The aim of this study was to evaluate the analytical and clinical performance of the quantitative Adenovirus ELITe MGB® Kit (ELITechGroup S.p.A.) using the ELITe BeGenius® (ELITechGroup S.p.A.) system and compare the assay to a laboratory-developed quantitative real-time PCR assay.

Study design

Analytical sensitivity of the Adenovirus ELITe MGB® Kit was determined by testing serial dilutions of the WHO standard. Detection of adenovirus serotypes was assessed using a panel of 51 serotypes. Clinical sensitivity and specificity were determined by comparing the Adenovirus ELITe MGB® Kit results with the laboratory-developed assay results of 155 retrospective and prospective EDTA-plasma samples from transplant recipients.

Results

The analytical sensitivity of the Adenovirus ELITe MGB® Kit was at least 54 (1.7 Log) IU/mL and the quantitative results showed a high correlation with the WHO standard (R² = 0.9978; Pearson) within the range of 1.7 to 6.6 Log IU/mL. All 51 adenovirus serotypes were detected. The clinical specificity and sensitivity for EDTA plasma of the Adenovirus ELITe MGB® Kit were 97.4 % and 99.1 % respectively.

Conclusion

The Adenovirus ELITe MGB® Kit performed on the ELITe BeGenius® system is a highly sensitive and specific assay for the detection of adenovirus in EDTA-plasma from transplantation patients.

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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)