Practical Validation of United States Centers for Disease Control and Prevention Assays for the Detection of Human Respiratory Syncytial Virus in Pediatric Inpatients in Japan
Reiko Suwa,
Yohei Kume,
Miyuki Kawase,
Mina Chishiki,
Takashi Ono,
Sakurako Norito,
Ko Sato,
Michiko Okamoto,
Satoru Kumaki,
Yukio Nagai,
Mitsuaki Hosoya,
Makoto Takeda,
Hidekazu Nishimura,
Koichi Hashimoto,
Kazuya Shirato
Affiliations
Reiko Suwa
Department of Virology III, National Institute of Infectious Diseases, 4-7-1 Gakuen, Musashimurayama 208-0011, Tokyo, Japan
Yohei Kume
Department of Pediatrics, School of Medicine, Fukushima Medical University, 1 Hikariga-Oka, Fukushima 960-1295, Fukushima, Japan
Miyuki Kawase
Department of Virology III, National Institute of Infectious Diseases, 4-7-1 Gakuen, Musashimurayama 208-0011, Tokyo, Japan
Mina Chishiki
Department of Pediatrics, School of Medicine, Fukushima Medical University, 1 Hikariga-Oka, Fukushima 960-1295, Fukushima, Japan
Takashi Ono
Department of Pediatrics, School of Medicine, Fukushima Medical University, 1 Hikariga-Oka, Fukushima 960-1295, Fukushima, Japan
Sakurako Norito
Department of Pediatrics, School of Medicine, Fukushima Medical University, 1 Hikariga-Oka, Fukushima 960-1295, Fukushima, Japan
Ko Sato
Virus Research Center, Clinical Research Division, Sendai Medical Center, National Hospital Organization, 2-11-12 Miyagino, Miyagino-ku, Sendai 983-8520, Miyagi, Japan
Michiko Okamoto
Virus Research Center, Clinical Research Division, Sendai Medical Center, National Hospital Organization, 2-11-12 Miyagino, Miyagino-ku, Sendai 983-8520, Miyagi, Japan
Satoru Kumaki
Department of Pediatrics, Sendai Medical Center, National Hospital Organization, 2-11-12 Miyagino, Miyagino-ku, Sendai 980-8575, Miyagi, Japan
Yukio Nagai
Nagai Pediatric Clinic, 1-25-10 Miyagino, Miyagino-ku, Sendai 983-0045, Miyagi, Japan
Mitsuaki Hosoya
Department of Pediatrics, School of Medicine, Fukushima Medical University, 1 Hikariga-Oka, Fukushima 960-1295, Fukushima, Japan
Makoto Takeda
Department of Virology III, National Institute of Infectious Diseases, 4-7-1 Gakuen, Musashimurayama 208-0011, Tokyo, Japan
Hidekazu Nishimura
Virus Research Center, Clinical Research Division, Sendai Medical Center, National Hospital Organization, 2-11-12 Miyagino, Miyagino-ku, Sendai 983-8520, Miyagi, Japan
Koichi Hashimoto
Department of Pediatrics, School of Medicine, Fukushima Medical University, 1 Hikariga-Oka, Fukushima 960-1295, Fukushima, Japan
Kazuya Shirato
Department of Virology III, National Institute of Infectious Diseases, 4-7-1 Gakuen, Musashimurayama 208-0011, Tokyo, Japan
The World Health Organization initiated a global surveillance system for respiratory syncytial virus (RSV) in 2015, and the pilot surveillance is ongoing. The real-time RT-PCR RSV assays (Pan-RSV and duplex assays) developed by the United States Centers for Disease Control and Prevention are applied as the standard assays. To introduce these as standard assays in Japan, their practicality was evaluated using 2261 specimens obtained from pediatric inpatients in Japan, which were collected from 2018 to 2021. Although the Pan-RSV and duplex assays had similar analytical sensitivities, they yielded 630 (27.9%) and 786 (34.8%) RSV-positive specimens, respectively (p < 0.001). Although sequencing analysis showed mismatches in the reverse primer used in the Pan-RSV assay, these mismatches did not affect its analytical sensitivity. The analysis of read numbers of RSV isolates from air–liquid interface culture of human bronchial/tracheal epithelial cells showed that the duplex assay had a greater number of reads than did the Pan-RSV assay. Therefore, the duplex assay has superior detection performance compared with the Pan-RSV assay, but the two assays have similar analytical sensitivities.
