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SARS-CoV-2 antigen rapid diagnostic test enhanced with silver amplification technology
Kei Miyakawa; Rikako Funabashi; Yutaro Yamaoka; Sundararaj Stanleyraj Jeremiah; Junichi Katada; Atsuhiko Wada; Toshiki Takei; Kohei Shimizu; Hiroki Ozawa; Chiharu Kawakami; Shuzo Usuku; Nobuko Tanaka; Etsuko Yamazaki; Hideaki Shimizu; Nobuhiko Okabe; Hideki Hasegawa; Akihide Ryo.
  • Kei Miyakawa; Yokohama City University School of Medicine
  • Rikako Funabashi; Yokohama City University School of Medicine
  • Yutaro Yamaoka; Yokohama City University School of Medicine
  • Sundararaj Stanleyraj Jeremiah; Yokohama City University School of Medicine
  • Junichi Katada; FUJIFILM Corporation
  • Atsuhiko Wada; FUJIFILM Corporation
  • Toshiki Takei; FUJIFILM Corporation
  • Kohei Shimizu; Yokohama City Institute of Public Health
  • Hiroki Ozawa; Yokohama City Institute of Public Health
  • Chiharu Kawakami; Yokohama City Institute of Public Health
  • Shuzo Usuku; Yokohama City Institute of Public Health
  • Nobuko Tanaka; Yokohama City Institute of Public Health
  • Etsuko Yamazaki; Yokohama City University Hospital
  • Hideaki Shimizu; Kawasaki City Institute for Public Health
  • Nobuhiko Okabe; Kawasaki City Institute for Public Health
  • Hideki Hasegawa; National Institute of Infectious Diseases
  • Akihide Ryo; Yokohama City University School of Medicine
Preprint in English | medRxiv | ID: ppmedrxiv-21250659
ABSTRACT
Rapid diagnosis of COVID-19 is essential for instituting measures to prevent viral spread. SARS-CoV-2 antigen rapid diagnostic test (Ag-RDT) based on lateral flow immunochromatography assay (LFIA) principle can visually indicate the presence of SARS-CoV-2 antigens as a band. Ag-RDT is clinically promising as a point-of-care testing because it can give results in a short time without the need for special equipment. Although various antigen capture LFIAs are now available for rapid diagnosis for SARS-CoV-2 infection, they face the problems of low sensitivity. We have previously developed highly specific monoclonal antibodies (mAb) against SARS-CoV-2 nucleocapsid protein (NP) and in this study, we have employed these mAbs to develop a new LFIA that can detect SARS-CoV-2 NP in nasopharyngeal swab samples with higher sensitivity by combining them with silver amplification technology. We also compared the performance of our Ag-RDT against the commercially available Ag-RDTs using clinical samples to find that our newly developed LFIA performed best among tested, highlighting the superiority of silver amplification technology.
Full text: Available Collection: Preprints Database: medRxiv Type of study: Diagnostic study Language: English Year: 2021 Document Type: Preprint

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Full text: Available Collection: Preprints Database: medRxiv Type of study: Diagnostic study Language: English Year: 2021 Document Type: Preprint