LAMPOX:一种用于检测流行的IIb分支猴痘病毒的便携式快速分子诊断检测方法。

LAMPOX: A Portable and Rapid Molecular Diagnostic Assay for the Epidemic Clade IIb Mpox Virus Detection.

作者信息

Garbuglia Anna Rosa, Draye Mallory, Pauciullo Silvia, Lapa Daniele, Specchiarello Eliana, Nazé Florence, Mertens Pascal

机构信息

Virology Laboratory, National Institute for Infectious Diseases "Lazzaro Spallanzani" IRCCS, 00149 Rome, Italy.

Coris BioConcept, Crealys Science Park, 5032 Gembloux, Belgium.

出版信息

Diagnostics (Basel). 2025 Aug 4;15(15):1959. doi: 10.3390/diagnostics15151959.

Abstract

The global spread of Mpox virus (MPXV) underscores the urgent need for rapid, field-deployable diagnostic tools, especially in low-resource settings. We evaluated a loop-mediated isothermal amplification (LAMP) assay, termed LAMPOX, developed by Coris BioConcept. The assay was tested in three formats-two liquid versions and a dried, ready-to-use version-targeting only the ORF F3L (Liquid V1) or both the ORF F3L and N4R (Liquid V2 and dried) genomic regions. Analytical sensitivity and specificity were assessed using 60 clinical samples from confirmed MPXV-positive patients. Sensitivity on clinical samples was 81.7% for Liquid V1 and 88.3% for Liquid V2. The dried LAMPOX assay demonstrated a sensitivity of 88.3% and a specificity of 100% in a panel of 112 negative controls, with most positive samples detected in under 7 min. Additionally, a simplified sample lysis protocol was developed to facilitate point-of-care use. While this method showed slightly reduced sensitivity compared to standard DNA extraction, it proved effective for samples with higher viral loads. The dried format offers key advantages, including ambient-temperature stability and minimal equipment needs, making it suitable for point-of-care testing. These findings support LAMPOX as a promising tool for rapid MPXV detection during outbreaks, especially in resource-limited settings where traditional PCR is impractical.

摘要

猴痘病毒(MPXV)的全球传播凸显了对快速、可现场部署的诊断工具的迫切需求,尤其是在资源匮乏的环境中。我们评估了Coris BioConcept公司开发的一种环介导等温扩增(LAMP)检测方法,称为LAMPOX。该检测方法以三种形式进行测试——两种液体版本和一种干燥即用型版本,分别针对开放阅读框F3L(液体V1)或开放阅读框F3L和N4R(液体V2和干燥型)基因组区域。使用来自确诊MPXV阳性患者的60份临床样本评估分析灵敏度和特异性。液体V1对临床样本的灵敏度为81.7%,液体V2为88.3%。干燥的LAMPOX检测方法在一组112份阴性对照中显示出88.3%的灵敏度和100%的特异性,大多数阳性样本在7分钟内被检测到。此外,还开发了一种简化的样本裂解方案,以方便即时检测使用。虽然这种方法与标准DNA提取相比灵敏度略有降低,但对病毒载量较高的样本证明是有效的。干燥形式具有关键优势,包括常温稳定性和最少的设备需求,使其适用于即时检测。这些发现支持LAMPOX作为一种在疫情爆发期间快速检测MPXV的有前景的工具,特别是在传统PCR不实用的资源有限环境中。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/475a/12346805/afc4bbd5a1a9/diagnostics-15-01959-g001.jpg

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