Journal of infection and chemotherapy : official journal of the Japan Society of Chemotherapy · 2026
Prospective multicenter evaluation of the QuickNavi-Campylobacter assay in stool specimens.
СтатьяМногоцентровое исследованиеОценочное исследованиеНазвание и аннотация: Перевод в очереди
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Hatakeyama Shinji, Hirose Yumi, Akashi Yusaku, Kusama Tomoka, Ishimaru Naoto, Morimoto Eri, Iwashima Satoru, Suzuki Kenji, Enomoto Keisuke, Suzuki Satoshi, Sekine Michiko, Nishimura Tatsuo, Terada Norihiko, Takahashi-Igari Miho, Abe Mariko, Yamada Kota, Kato Daisuke, Ohkusu Kiyofumi, Suzuki Hiromichi
Аннотация
INTRODUCTION: A rapid diagnosis of Campylobacter infections is important for managing infectious gastroenteritis. Although stool culture is considered the gold standard, its sensitivity is limited, and it requires prolonged incubation times.
METHODS: We conducted a prospective multicenter study at nine healthcare facilities in Japan to evaluate a Campylobacter rapid antigen test using stool specimens between March 2024 and August 2025. Patients with suspected infectious gastroenteritis were consecutively enrolled and tested using QuickNavi-Campylobacter, and the results were compared with those obtained using the FilmArray Gastrointestinal Panel as the reference method. Discordant results were further evaluated using cultures and additional PCR assays.
RESULTS: A total of 410 patients were included in the final analysis. When the FilmArray Gastrointestinal Panel was used as the reference method, the positive concordance rate of QuickNavi-Campylobacter was 78.8%, and the negative and total concordance rates were 99.0% and 93.4%, respectively. The positive concordance rate decreased in specimens collected ≥6 days after the onset of symptoms (50.0%). Among the 29 patients who received antimicrobial agents before testing, Campylobacter spp. Were detected by the FilmArray GI Panel in five patients, whereas only one of these patients was positive by the antigen assay.
CONCLUSIONS: QuickNavi-Campylobacter showed acceptable concordance with the FilmArray Gastrointestinal Panel in a real-world multicenter setting, and its diagnostic utility may be more evident in the early phase of illnesses, although prior antimicrobial exposure may reduce its sensitivity.
METHODS: We conducted a prospective multicenter study at nine healthcare facilities in Japan to evaluate a Campylobacter rapid antigen test using stool specimens between March 2024 and August 2025. Patients with suspected infectious gastroenteritis were consecutively enrolled and tested using QuickNavi-Campylobacter, and the results were compared with those obtained using the FilmArray Gastrointestinal Panel as the reference method. Discordant results were further evaluated using cultures and additional PCR assays.
RESULTS: A total of 410 patients were included in the final analysis. When the FilmArray Gastrointestinal Panel was used as the reference method, the positive concordance rate of QuickNavi-Campylobacter was 78.8%, and the negative and total concordance rates were 99.0% and 93.4%, respectively. The positive concordance rate decreased in specimens collected ≥6 days after the onset of symptoms (50.0%). Among the 29 patients who received antimicrobial agents before testing, Campylobacter spp. Were detected by the FilmArray GI Panel in five patients, whereas only one of these patients was positive by the antigen assay.
CONCLUSIONS: QuickNavi-Campylobacter showed acceptable concordance with the FilmArray Gastrointestinal Panel in a real-world multicenter setting, and its diagnostic utility may be more evident in the early phase of illnesses, although prior antimicrobial exposure may reduce its sensitivity.