Development and clinical evaluation of a MPXV antigen-detecting rapid diagnostic test

IF 1.6 4区医学 Q3 BIOCHEMICAL RESEARCH METHODS

Journal of virological methods Pub Date : 2025-05-08 DOI:10.1016/j.jviromet.2025.115164

Nobuyuki Kurosawa , Tatsuhiko Ozawa , Kousei Ozawa , Masayuki Shimojima , Madoka Kawahara , Fumi Kasuya , Wakaba Okada , Mami Nagashima , Kenji Sadamasu , Masae Itamochi , Hideki Tani , Yoshitomo Morinaga , Kosuke Yuhara , Jun Okamoto , Haruna Ichikawa , Takashi Kawahata , Tomomi Yamazaki , Masaharu Isobe

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引用次数: 0

Abstract

To address the global emergence of mpox after the 2022 epidemic, a rapid and accurate diagnostic tool is needed at the point of care to identify individuals infected with mpox virus (MPXV) to prevent and control the spread of the virus. We designed an antigen-detecting rapid diagnostic test that exclusively detects MPXV without cross-reacting with the vaccinia virus by developing monoclonal antibodies against the MPXV nuclear capsid protein A5L (MPXV-A5L). The test results indicated that the detection limits were established at 0.5 ng/mL for MPXV-A5L and 4.4 × 10² ∼ 2.1 × 10³ pfu/mL for MPXV culture fluid. Clinical samples collected from MPXV patients showed a high sensitivity of 87 % at a qPCR cycle threshold of 25 or lower, with a specificity of 100 % for samples that tested negative in the qPCR. The test is an ideal rapid diagnostic tool for supporting clinical decision-making for people suspected of having MPXV infection in resource-poor settings.

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m痘抗原检测快速诊断试验的研制与临床评价。

为应对2022年流行后全球出现的mpox，需要在医疗点使用快速准确的诊断工具来识别感染mpox病毒（MPXV）的个体，以预防和控制该病毒的传播。我们设计了一种抗原检测快速诊断试验，该试验通过制备针对MPXV核衣壳蛋白A5L （MPXV-A5L）的单克隆抗体，可以单独检测MPXV，而不与牛痘病毒发生交叉反应。结果表明，MPXV- a5l的检出限为0.5ng/mL， MPXV培养液的检出限为4.4 × 102 ~ 2.1 × 103 pfu/mL。从MPXV患者收集的临床样本显示，在qPCR周期阈值为25或更低时，灵敏度高达87%，对于qPCR检测为阴性的样本，特异性为100%。该检测是一种理想的快速诊断工具，用于支持资源贫乏环境中疑似MPXV感染者的临床决策。

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.