Improving the Detection Sensitivity of a New Rapid Diagnostic Technology for Severe Acute Respiratory Syndrome Coronavirus 2 Using a Trace Amount of Saliva
Reiko Tokuyama-Toda,
Chika Terada-Ito,
Masaaki Muraoka,
Toshikatsu Horiuchi,
Tsuyoshi Amemiya,
Airi Fukuoka,
Yoshiki Hamada,
Yusuke Takebe,
Takashi Ogawa,
Seiko Fujii,
Toshihiro Kikuta,
Shunsuke Sejima,
Kazuhito Satomura
Affiliations
Reiko Tokuyama-Toda
Department of Oral Medicine and Stomatology, School of Dental Medicine, Tsurumi University, 2-1-3, Tsurumi, Tsurumi-ku, Yokohama City 230-8501, Kanagawa, Japan
Chika Terada-Ito
Department of Oral Medicine and Stomatology, School of Dental Medicine, Tsurumi University, 2-1-3, Tsurumi, Tsurumi-ku, Yokohama City 230-8501, Kanagawa, Japan
Masaaki Muraoka
Certified Non-Profit Organization Biomedical Science Association, 2-20-8, Kamiosaki, Shinagawa-ku 141-0021, Tokyo, Japan
Toshikatsu Horiuchi
Department of Oral and Maxillofacial Surgery, Saiseikai Yokohamashi Tobu Hospital, 3-6-1, Shimosueyoshi, Tsurumi-ku, Yokohama City 230-8765, Kanagawa, Japan
Tsuyoshi Amemiya
Department of Oral and Maxillofacial Surgery, Saiseikai Yokohamashi Tobu Hospital, 3-6-1, Shimosueyoshi, Tsurumi-ku, Yokohama City 230-8765, Kanagawa, Japan
Airi Fukuoka
Department of Oral and Maxillofacial Surgery, Saiseikai Yokohamashi Tobu Hospital, 3-6-1, Shimosueyoshi, Tsurumi-ku, Yokohama City 230-8765, Kanagawa, Japan
Yoshiki Hamada
Department of Oral and Maxillofacial Surgery, School of Dental Medicine, Tsurumi University, 2-1-3, Tsu-rumi, Tsurumi-ku, Yokohama City 230-8501, Kanagawa, Japan
Yusuke Takebe
Department of Oral Medicine and Stomatology, School of Dental Medicine, Tsurumi University, 2-1-3, Tsurumi, Tsurumi-ku, Yokohama City 230-8501, Kanagawa, Japan
Takashi Ogawa
Department of Oral and Maxillofacial Surgery, Tokyo Medical University Hachioji Medical Center, 1163, Tatemachi, Hachioji City 193-0998, Tokyo, Japan
Seiko Fujii
Department of Oral and Maxillofacial Surgery, Shin-Yurigaoka General Hospital, 255, Furusawatsuko, Asao-ku, Kawasaki City 215-0026, Kanagawa, Japan
Toshihiro Kikuta
Department of Oral and Maxillofacial Surgery, Shin-Yurigaoka General Hospital, 255, Furusawatsuko, Asao-ku, Kawasaki City 215-0026, Kanagawa, Japan
Shunsuke Sejima
Certified Non-Profit Organization Biomedical Science Association, 2-20-8, Kamiosaki, Shinagawa-ku 141-0021, Tokyo, Japan
Kazuhito Satomura
Department of Oral Medicine and Stomatology, School of Dental Medicine, Tsurumi University, 2-1-3, Tsurumi, Tsurumi-ku, Yokohama City 230-8501, Kanagawa, Japan
The early diagnosis and isolation of infected individuals with coronavirus disease 2019 (COVID-19) remain important. Although quantitative polymerase chain reaction (qPCR) testing is considered the most accurate test available for COVID-19 diagnosis, it has some limitations, such as the need for specialized laboratory technicians and a long turnaround time. Therefore, we have established and reported a rapid diagnostic method using a small amount of saliva as a sample using a lightweight mobile qPCR device. This study aimed to improve the existing method and increase the detection sensitivity and specificity. The detection specificity of CDC N1 and N2 was examined by improving qPCR reagents and polymerase chain reaction conditions for the previously reported method. Furthermore, the feasibility of detecting severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral RNA was examined using both the previous method and the improved method in patients with COVID-19. The results showed that the improved method increased the specificity and sensitivity. This improved method is useful for the rapid diagnosis of SARS-CoV-2.
