Development and Clinical Evaluation of a Mpox Antigen-detecting Rapid Diagnostic Test.

Journal: Journal of virological methods
Published Date: May 7, 2025

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 0.5ng/mL for MPXV-A5L and 4.4 × 10 ~ 2.1 × 10 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.

Authors

  • Nobuyuki Kurosawa
    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.
  • Tatsuhiko Ozawa
    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.
  • Kousei Ozawa
    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.
  • Masayuki Shimojima
    Department of Virology I, National Institute of Infectious Diseases, Toyama 1-23-1, Shinjuku-ku, Tokyo 162-8640, Japan.
  • Madoka Kawahara
    Department of Virology I, National Institute of Infectious Diseases, Toyama 1-23-1, Shinjuku-ku, Tokyo 162-8640, Japan.
  • Fumi Kasuya
    Department of Microbiology, Tokyo Metropolitan Institute of Public Health, 3-24-1 Hyakunincho, Shinjuku-ku, Tokyo, Japan.
  • Wakaba Okada
    Department of Microbiology, Tokyo Metropolitan Institute of Public Health, 3-24-1 Hyakunincho, Shinjuku-ku, Tokyo, Japan.
  • Mami Nagashima
    Department of Microbiology, Tokyo Metropolitan Institute of Public Health, 3-24-1 Hyakunincho, Shinjuku-ku, Tokyo, Japan.
  • Kenji Sadamasu
    Department of Microbiology, Tokyo Metropolitan Institute of Public Health, 3-24-1 Hyakunincho, Shinjuku-ku, Tokyo, Japan.
  • Masae Itamochi
    Department of Virology, Toyama Institute of Health, 7-1 Nakataikoyama, Imizu-shi, Toyama 939-0363, Japan.
  • Hideki Tani
    Department of Virology, Toyama Institute of Health, 7-1 Nakataikoyama, Imizu-shi, Toyama 939-0363, Japan.
  • Yoshitomo Morinaga
    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.
  • Kosuke Yuhara
    Biotechnology Research Laboratory, TOYOBO Co., Ltd., 10-24, Toyo-Cho, Tsuruga-Shi, Fukui, 914-8550, Japan.
  • Jun Okamoto
    Biotechnology Research Laboratory, TOYOBO Co., Ltd., 10-24, Toyo-Cho, Tsuruga-Shi, Fukui, 914-8550, Japan.
  • Haruna Ichikawa
    Biotechnology Research Laboratory, TOYOBO Co., Ltd., 10-24, Toyo-Cho, Tsuruga-Shi, Fukui, 914-8550, Japan.
  • Takashi Kawahata
    Biotechnology Research Laboratory, TOYOBO Co., Ltd., 10-24, Toyo-Cho, Tsuruga-Shi, Fukui, 914-8550, Japan.
  • Tomomi Yamazaki
    Biotechnology Research Laboratory, TOYOBO Co., Ltd., 10-24, Toyo-Cho, Tsuruga-Shi, Fukui, 914-8550, Japan.
  • Masaharu Isobe
    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.

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