Shoichi Sawada: Sawada Eye and Ear Clinic, Kochi, Kochi, Japan.
Yukako Goto: Department of Otorhinolaryngology, Konan Medical Center, Kobe, Hyogo, Japan.
Akihiro Uchizono: Sendai ENT Clinic, Satsumasendai, Kagoshima, Japan.
Daichi Murakami: Department of Otorhinolaryngology-Head and Neck Surgery, Wakayama Medical University, Wakayama, Wakayama, Japan.
Takuji Miyata: Asahi Kasei Corporation, Corporate Research & Development, Healthcare R&D Center, Rapid Diagnostic Technology, Fuji, Shizuoka, Japan.
Norikazu Okamura: Asahi Kasei Corporation, Corporate Research & Development, Healthcare R&D Center, Clinical Development Department, Chiyoda-ku Yuraku-cho, Tokyo, Japan.
Muneki Hotomi: Department of Otorhinolaryngology-Head and Neck Surgery, Wakayama Medical University, Wakayama, Wakayama, Japan. Electronic address: mhotomi@wakayama-med.ac.jp.
BACKGROUND: Rapid identification of causative bacteria in treatment of acute otitis media (AOM) is of paramount importance for appropriate antibiotic use. MATERIALS AND METHODS: This prospective observational study was conducted in 15 hospitals and clinics in Japan between 2018 and 2020. A new rapid antigen test kit (AOS-116), which simultaneously detects antigens for Streptococcus pneumoniae (Sp) and Haemophilus influenzae (Hi), was applied for middle ear fluids (MEFs) and nasopharyngeal secretions (NPSs) in patients with moderate to severe AOM. We investigated relationship between the results of rapid test, severity at initial visit, and clinical course. RESULTS: Regarding performance accuracy based on culture results, AOS-116 showed 1) high (>80%) sensitivity, specificity, and negative predictive value (NPV) in MEFs for both antigens, 2) high sensitivity, specificity, and positive predictive value (PPV) in NPSs for Hi antigen, and 3) high specificity, and PPV in NPSs for Sp antigen. Regarding predictive value of nasopharyngeal culture and antigen detection for causative middle ear pathogens, similar results were observed between AOS-116 and culture, which was characterized with high sensitivity and NPV for both pathogens. MEFs/NPSs positive for Hi antigen were significantly associated with eardrum findings, and severity. MEFs/NPSs positive for pneumococcal antigen were significantly associated with severity of otalgia, fever, and otorrhea. Among patients with prior antimicrobial treatment, improvement tended to be slower in cases positive for Hi than in cases negative. CONCLUSION: The rapid antigen detection test is useful as a decision-making tool for prescribing antimicrobial agents and may play an important role in promoting appropriate antimicrobial use.
