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

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Title: Development and clinical evaluation of a MPXV antigen-detecting rapid diagnostic test.
Authors: Kurosawa N; Department of Life Sciences and Bioengineering, Laboratory of Molecular and Cellular Biology, Faculty of Engineering, Academic Assembly, University of Toyama, 3190 Gofuku, Toyama-shi, Toyama 930-8555, Japan; Center for Advanced Antibody Drug Development, University of Toyama, 3190 Gofuku, Toyama-shi, Toyama 930-8555, Japan. Electronic address: kurosawa@eng.u-toyama.ac.jp., Ozawa T; Department of Life Sciences and Bioengineering, Laboratory of Molecular and Cellular Biology, Faculty of Engineering, Academic Assembly, University of Toyama, 3190 Gofuku, Toyama-shi, Toyama 930-8555, Japan; Center for Advanced Antibody Drug Development, University of Toyama, 3190 Gofuku, Toyama-shi, Toyama 930-8555, Japan., Ozawa K; Department of Life Sciences and Bioengineering, Laboratory of Molecular and Cellular Biology, Graduate School of Pharma-Medical Sciences, University of Toyama, 3190 Gofuku, Toyama-shi, Toyama 930-8555, Japan., Shimojima M; Department of Virology I, National Institute of Infectious Diseases, Toyama 1-23-1, Shinjuku-ku, Tokyo 162-8640, Japan., Kawahara M; Department of Virology I, National Institute of Infectious Diseases, Toyama 1-23-1, Shinjuku-ku, Tokyo 162-8640, Japan., Kasuya F; Department of Microbiology, Tokyo Metropolitan Institute of Public Health, 3-24-1 Hyakunincho, Shinjuku-ku, Tokyo, Japan., Okada W; Department of Microbiology, Tokyo Metropolitan Institute of Public Health, 3-24-1 Hyakunincho, Shinjuku-ku, Tokyo, Japan., Nagashima M; Department of Microbiology, Tokyo Metropolitan Institute of Public Health, 3-24-1 Hyakunincho, Shinjuku-ku, Tokyo, Japan., Sadamasu K; Department of Microbiology, Tokyo Metropolitan Institute of Public Health, 3-24-1 Hyakunincho, Shinjuku-ku, Tokyo, Japan., Itamochi M; Department of Virology, Toyama Institute of Health, 7-1 Nakataikoyama, Imizu-shi, Toyama 939-0363, Japan., Tani H; Department of Virology, Toyama Institute of Health, 7-1 Nakataikoyama, Imizu-shi, Toyama 939-0363, Japan., Morinaga Y; Center for Advanced Antibody Drug Development, University of Toyama, 3190 Gofuku, Toyama-shi, Toyama 930-8555, Japan; Department of Microbiology, Toyama University Graduate School of Medicine and Pharmaceutical Sciences, 2630 Sugitani, Toyama 930-0194, Japan., Yuhara K; Biotechnology Research Laboratory, TOYOBO Co., Ltd., 10-24, Toyo-Cho, Tsuruga-Shi, Fukui 914-8550, Japan., Okamoto J; Biotechnology Research Laboratory, TOYOBO Co., Ltd., 10-24, Toyo-Cho, Tsuruga-Shi, Fukui 914-8550, Japan., Ichikawa H; Biotechnology Research Laboratory, TOYOBO Co., Ltd., 10-24, Toyo-Cho, Tsuruga-Shi, Fukui 914-8550, Japan., Kawahata T; Biotechnology Research Laboratory, TOYOBO Co., Ltd., 10-24, Toyo-Cho, Tsuruga-Shi, Fukui 914-8550, Japan., Yamazaki T; Biotechnology Research Laboratory, TOYOBO Co., Ltd., 10-24, Toyo-Cho, Tsuruga-Shi, Fukui 914-8550, Japan., Isobe M; Department of Life Sciences and Bioengineering, Laboratory of Molecular and Cellular Biology, Faculty of Engineering, Academic Assembly, University of Toyama, 3190 Gofuku, Toyama-shi, Toyama 930-8555, Japan; Center for Advanced Antibody Drug Development, University of Toyama, 3190 Gofuku, Toyama-shi, Toyama 930-8555, Japan.
Source: Journal of virological methods [J Virol Methods] 2025 Sep; Vol. 337, pp. 115164. Date of Electronic Publication: 2025 May 08.
Publication Type: Journal Article; Evaluation Study; Research Support, Non-U.S. Gov't
Language: English
Journal Info: Publisher: Elsevier/North-Holland Biomedical Press Country of Publication: Netherlands NLM ID: 8005839 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1879-0984 (Electronic) Linking ISSN: 01660934 NLM ISO Abbreviation: J Virol Methods Subsets: MEDLINE
Imprint Name(s): Original Publication: [Amsterdam] : Elsevier/North-Holland Biomedical Press, 1980-
MeSH Terms: Antigens, Viral*/immunology , Antigens, Viral*/analysis , Capsid Proteins*/immunology , Diagnostic Tests, Routine*/methods , Monkeypox virus*/isolation & purification, Humans ; Antibodies, Monoclonal/immunology ; Antibodies, Viral/immunology ; Rapid Diagnostic Tests ; Sensitivity and Specificity ; Mpox, Monkeypox/diagnosis
Abstract: Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
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 × 10 2 ∼ 2.1 × 10 3 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.
(Copyright © 2025 The Authors. Published by Elsevier B.V. All rights reserved.)
Contributed Indexing: Keywords: Antigen-detecting rapid diagnostic test; Clinical evaluation; Lateral flow immunochromatography assay; Monoclonal antibody; Mpox; qPCR
Substance Nomenclature: 0 (Antibodies, Monoclonal)
0 (Antibodies, Viral)
0 (Antigens, Viral)
0 (Capsid Proteins)
Entry Date(s): Date Created: 20250509 Date Completed: 20250608 Latest Revision: 20250625
Update Code: 20250626
DOI: 10.1016/j.jviromet.2025.115164
PMID: 40345596
Database: MEDLINE
Description
Abstract:Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.<br />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 × 10 <sup>2</sup> ∼ 2.1 × 10 <sup>3</sup> 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.<br /> (Copyright © 2025 The Authors. Published by Elsevier B.V. All rights reserved.)
ISSN:1879-0984
DOI:10.1016/j.jviromet.2025.115164