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Article

Highly Sensitive and Quantitative Diagnosis of SARS-CoV-2 Using a Gold/Platinum Particle-Based Lateral Flow Assay and a Desktop Scanning Electron Microscope

1
Institute for NanoSuit Research, Preeminent Medical Photonics Education & Research Center, Hamamatsu University School of Medicine, 1-20-1 Handayama, Higashi-ku, Hamamatsu 431-3192, Japan
2
Department of Laboratory Medicine, Hamamatsu University School of Medicine, 1-20-1 Handayama, Higashi-ku, Hamamatsu 431-3192, Japan
3
Research & Development Group, Hitachi Ltd., 1-280, Higashi-Koigakubo, Kokubunji-shi, Tokyo 185-8601, Japan
4
Social Solution Department, Hitachi Social Information Services Ltd., Omori Bellport D 17F, 6-26-3, Minamioi, Shinagawa-ku, Tokyo 140-0013, Japan
5
NanoSuit Inc., 1-20-1 Handayama, Higashi-ku, Hamamatsu 431-3192, Japan
*
Author to whom correspondence should be addressed.
Academic Editor: Célia F. Rodrigues
Biomedicines 2022, 10(2), 447; https://doi.org/10.3390/biomedicines10020447
Received: 14 January 2022 / Revised: 4 February 2022 / Accepted: 5 February 2022 / Published: 15 February 2022
(This article belongs to the Section Gene and Cell Therapy)
The gold standard test for identifying SARS-CoV-2, the causative agent of COVID-19, is polymerase chain reaction (PCR). Despite their limited sensitivity, SARS-CoV-2 antigen rapid diagnostic tests are vital tools in the fight against viral spread. Owing to its simplicity and low cost, the lateral flow assay (LFA) is the most extensively used point-of-care diagnostic test. Here, we report a newly designed LFA-NanoSuit method (LNSM) that works in conjunction with desktop scanning electron microscopy (SEM) to detect SARS-CoV-2. LNSM requires no standard SEM treatment, avoids cellulose and residual buffer deformation, and enables the capture of high-resolution images of antibody-labeled gold/platinum particles reacting with SARS-CoV-2 antigens. To assess its applicability, we compared clinical SARS-CoV-2 samples via visual detection of LFA, LSNM detection of LFA, and real-time reverse transcription-PCR (qRT-PCR). Compared to qRT-PCR, LNSM showed 86.7% sensitivity (26/30; 95% confidence interval (CI): 69.28–96.24%) and 93.3% specificity (14/15; 95% CI: 68.05–99.83%) for SARS-CoV-2. In samples with a relatively low SARS-CoV-2 RNA copy number (30 < Ct ≤ 40), the sensitivity of LNSM was greater (73.3%) than that of visual detection (0%). A simple, sensitive, and quantitative LNSM can be used to diagnose SARS-CoV-2. View Full-Text
Keywords: desktop scanning electron microscopy; SARS-CoV-2; lateral flow assay; NanoSuit; COVID-19 desktop scanning electron microscopy; SARS-CoV-2; lateral flow assay; NanoSuit; COVID-19
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MDPI and ACS Style

Kawasaki, H.; Suzuki, H.; Furuhashi, K.; Yamashita, K.; Ishikawa, J.; Nagura, O.; Maekawa, M.; Miwa, T.; Tandou, T.; Hariyama, T. Highly Sensitive and Quantitative Diagnosis of SARS-CoV-2 Using a Gold/Platinum Particle-Based Lateral Flow Assay and a Desktop Scanning Electron Microscope. Biomedicines 2022, 10, 447. https://doi.org/10.3390/biomedicines10020447

AMA Style

Kawasaki H, Suzuki H, Furuhashi K, Yamashita K, Ishikawa J, Nagura O, Maekawa M, Miwa T, Tandou T, Hariyama T. Highly Sensitive and Quantitative Diagnosis of SARS-CoV-2 Using a Gold/Platinum Particle-Based Lateral Flow Assay and a Desktop Scanning Electron Microscope. Biomedicines. 2022; 10(2):447. https://doi.org/10.3390/biomedicines10020447

Chicago/Turabian Style

Kawasaki, Hideya, Hiromi Suzuki, Kazuki Furuhashi, Keita Yamashita, Jinko Ishikawa, Osanori Nagura, Masato Maekawa, Takafumi Miwa, Takumi Tandou, and Takahiko Hariyama. 2022. "Highly Sensitive and Quantitative Diagnosis of SARS-CoV-2 Using a Gold/Platinum Particle-Based Lateral Flow Assay and a Desktop Scanning Electron Microscope" Biomedicines 10, no. 2: 447. https://doi.org/10.3390/biomedicines10020447

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