Abstract：
BACKGROUND: Rapid identification of causative bacteria in treatment of acute otitis media (AOM) is of paramount importance for appropriate antibiotic use.
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.
CONCLUSIONS: 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.
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.
CONCLUSIONS: 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.
摘要：
背景：在治疗急性中耳炎（AOM）中快速鉴定致病菌对于适当使用抗生素至关重要。
方法：这项前瞻性观察研究于2018年至2020年在日本的15家医院和诊所进行。新型快速抗原检测试剂盒(AOS-116),同时检测肺炎链球菌（Sp）和流感嗜血杆菌（Hi）的抗原，适用于中耳液（MEFs）和鼻咽拭子（NPSs）的中度至重度AOM患者。我们调查了快速测试结果之间的关系，初次就诊时的严重程度，和临床课程。
结果：关于基于培养结果的性能准确性，AOS-116显示1)高(>80%)灵敏度，特异性，MEF中两种抗原的阴性预测值（NPV），2）灵敏度高，特异性，NPSs对Hi抗原的阳性预测值（PPV），和3)高特异性，和NPSs中的PPV为Sp抗原。关于鼻咽培养和抗原检测对致病中耳病原体的预测价值，在AOS-116和培养之间观察到类似的结果，这两种病原体的敏感性和NPV都很高。Hi抗原阳性的MEFs/NPSs与鼓膜发现显著相关，和严重性。肺炎球菌抗原阳性的MEFs/NPSs与耳痛的严重程度显著相关，发烧,和耳漏.在先前接受过抗菌治疗的患者中，Hi阳性病例的改善往往比阴性病例慢。
结论：快速抗原检测试验可作为抗菌药物处方的决策工具，并可能在促进抗菌药物的适当使用方面发挥重要作用。
方法：这项前瞻性观察研究于2018年至2020年在日本的15家医院和诊所进行。新型快速抗原检测试剂盒(AOS-116),同时检测肺炎链球菌（Sp）和流感嗜血杆菌（Hi）的抗原，适用于中耳液（MEFs）和鼻咽拭子（NPSs）的中度至重度AOM患者。我们调查了快速测试结果之间的关系，初次就诊时的严重程度，和临床课程。
结果：关于基于培养结果的性能准确性，AOS-116显示1)高(>80%)灵敏度，特异性，MEF中两种抗原的阴性预测值（NPV），2）灵敏度高，特异性，NPSs对Hi抗原的阳性预测值（PPV），和3)高特异性，和NPSs中的PPV为Sp抗原。关于鼻咽培养和抗原检测对致病中耳病原体的预测价值，在AOS-116和培养之间观察到类似的结果，这两种病原体的敏感性和NPV都很高。Hi抗原阳性的MEFs/NPSs与鼓膜发现显著相关，和严重性。肺炎球菌抗原阳性的MEFs/NPSs与耳痛的严重程度显著相关，发烧,和耳漏.在先前接受过抗菌治疗的患者中，Hi阳性病例的改善往往比阴性病例慢。
结论：快速抗原检测试验可作为抗菌药物处方的决策工具，并可能在促进抗菌药物的适当使用方面发挥重要作用。
