Determination of causative pathogens is the first step in successful antimicrobial treatments and appropriate antimicrobial uses. Streptococcus pneumoniae and nontypeable Haemophilus influenzae (NTHi) are the two leading causative bacteria responsible for acute otitis media (AOM) [1]. The clinical course of AOM has been reported to be associated with the causative pathogens 2, 3, 4, 5.

Penicillin-resistant S. pneumoniae (PRSP) is considered to be a global problem 6, 7, 8. Although the incidence of drug-resistant isolates has decreased since the introduction of pneumococcal conjugate vaccine (PCV), antimicrobial resistance is still a concern 9, 10. The prevalence of H. influenzae has increased in place of decreasing prevalence of S. pneumoniae. The increase in drug-resistant H. influenzae, particularly ß-lactamase non-producing ampicillin-resistant H. influenzae (BLNAR), has become an emerging problem of antimicrobial resistances in post-PCV era 9, 11.

The clinical treatment guidelines for AOM in Japan and other countries recommend amoxicillin as a first-line drug for antimicrobial therapy 12, 13, 14, 15. However, refractory cases still occur even after appropriate treatment and vaccination. It is of great value to determine the pathogens prior to antimicrobial treatments.

Bacterial culture is the gold standard for identifying causative pathogen. To overcome the disadvantages of bacterial culture, which takes time for bacterial growth, efforts have been made in recent years to develop rapid detection methods. Chromatographic antigen detection is one of the attractive approaches to identify the pathogens and has been applied in the clinical setting. However, current antigen test can only detect pneumococcal antigen. Rapid detection of H. influenzae has not yet been introduced into clinical practice. Most importantly, the impact of rapid antigen detecting test on the clinical decision making for the treatment of AOM has not been well evaluated.

In this study, we prospectively evaluated the performance of AOS-116 in the simultaneous qualitative detection of S. pneumoniae and H. influenzae in specimens collected from patients with AOM, and further demonstrated the value of AOS-116 in estimating the severity and clinical course of AOM.