International external quality assessment study for detection of monkeypox virus by PCR supporting laboratory preparedness during the 2022–2023 mpox outbreak and beyond

IF 4 3区医学 Q2 VIROLOGY

Journal of Clinical Virology Pub Date : 2024-10-21 DOI:10.1016/j.jcv.2024.105741

Rosina Ehmann , Oliver Donoso Mantke , Elaine McCulloch , Amani Yousef , Alastair Ricketts , Harry Staines , Joachim J. Bugert , Roman Wölfel , Hubert G.M. Niesters

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引用次数: 0

Abstract

Background

Diagnostic capabilities and correspondent External Quality Assessments (EQA) are key for outbreak preparedness. To support diagnostic facilities with a quality assessment of newly established monkeypox virus (MPXV) molecular diagnostic workflows, Quality Control for Molecular Diagnostics (QCMD) and the Bundeswehr Institute of Microbiology (IMB) piloted an international EQA study conducting four challenges from autumn 2022 to summer 2023 during the global mpox outbreak.

Objectives

To assess the performance (sensitivity/specificity) of molecular assays used by diagnostic laboratories.

Study design

Inactivated EQA panels were prepared and distributed containing seven samples of clade Ia and clade IIb MPXV strains at different viral concentrations, two specificity controls with other zoonotic orthopoxviruses (vaccinia and cowpox virus) and a negative control. Assessment was based on reported qualitative testing results.

Results

In this outbreak-related EQA study, a total of 192 laboratories from 37 countries reported 346 qualitative datasets. Overall, core samples were correctly detected by approximately 92 % of participants in all four challenges. While sensitivity performance was acceptable in at least 90 % of datasets correctly reported even for educational MPXV-positive samples with low viral concentration [10² genome equivalents (GE)/mL], several laboratories reported the educational specificity controls as false positives or were unable to differentiate MPXV from related orthopoxviruses.

Conclusions

Mpox is now a globally occurring infection with a demand for quality-assured diagnostic capabilities. The newly established EQA scheme presented here, offers a multi-purpose panel for orthopoxviruses with a focus on MPXV which will continue to ensure diagnostic quality in clinical settings with up-to-date sample panels.

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通过 PCR 检测猴痘病毒的国际外部质量评估研究，支持实验室在 2022-2023 年猴痘爆发期间及以后做好准备。

背景：诊断能力和相应的外部质量评估（EQA）是防范疫情爆发的关键。为支持诊断机构对新建立的猴痘病毒（MPXV）分子诊断工作流程进行质量评估，分子诊断质量控制中心（QCMD）和德国联邦国防军微生物研究所（IMB）在2022年秋季至2023年夏季全球猴痘疫情暴发期间开展了一项国际外部质量评估试点研究，进行了四次挑战：评估诊断实验室使用的分子检测方法的性能（灵敏度/特异性）：研究设计：制备并分发了灭活的 EQA 面板，其中包含七份不同病毒浓度的 Ia 支和 IIb 支 MPXV 株样本、两份含有其他人畜共患病正痘病毒（疫苗和牛痘病毒）的特异性对照和一份阴性对照。评估基于报告的定性检测结果：在这项与疫情相关的 EQA 研究中，共有来自 37 个国家的 192 个实验室报告了 346 个定性数据集。总体而言，在所有四项挑战中，约 92% 的参与者都能正确检测出核心样本。即使是病毒浓度较低的MPXV阳性教育样本[102基因组当量（GE）/毫升]，至少有90%的数据集报告正确，灵敏度表现尚可接受，但一些实验室报告的教育特异性对照为假阳性，或无法将MPXV与相关正痘病毒区分开来：结论：MPXV 现已成为一种全球性感染，需要有质量保证的诊断能力。本文介绍的新建立的 EQA 计划提供了一个以 MPXV 为重点的骨痘病毒多用途样本库，它将继续确保临床环境中最新样本库的诊断质量。

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)