title: Diagnostic sensitivity of a rapid antigen test for the detection of Mycoplasma pneumoniae: Comparison with real-time PCR.
abstract: A rapid antigen kit for the detection of the Mycoplasma pneumoniae ribosomal protein L7/L12 using an immunochromatographic assay, Ribotest Mycoplasma, became available in Japan in 2013. To determine the sensitivity of Ribotest compared with real-time polymerase chain reaction (PCR), we prospectively performed these two tests simultaneously in adolescent and adult patients with community-acquired pneumonia (CAP). In addition, we retrospectively analyzed the theoretical sensitivity of Ribotest using M. pneumoniae PCR-positive specimens from previous studies. In prospective study, 118 CAP cases were enrolled, and 16 cases were diagnosed as M. pneumoniae pneumonia; eight cases were PCR-positive, one case was culture positive, and all cases demonstrated a four-fold increase in antibody titer. Ribotest was positive in 15 cases; five cases were PCR positive and 10 cases were PCR negative. For the PCR was control test, the sensitivity, specificity, and overall agreement with Ribotest were 62.5%, 90.9%, and 88.9%, respectively. In the retrospective study, we used 1110 M. pneumoniae PCR-positive specimens, which are collected from pediatric patients with respiratory tract infection who visited 65 institutions throughout Japan. Using a cut-off level for the Ribotest of 8.3 × 10(4) copy/mL in transport medium, 667 (60.0%) specimens were theoretically positive. In conclusion, our prospective and retrospective results demonstrated that the diagnostic sensitivity of Ribotest compared with PCR was not high, at approximately 60%. Thus, treatment decisions about M. pneumoniae pneumonia should be based on clinical findings such as Japanese Respiratory Society scoring system and not on Ribotest results alone.
authors.affiliation: Department of Internal Medicine 1, Kawasaki Medical School, Okayama, Japan. Electronic address: nao@med.kawasaki-m.ac.jp.
authors.forename: Naoyuki
authors.initials: N
authors.lastname: Miyashita
authors.affiliation: Department of Internal Medicine 1, Kawasaki Medical School, Okayama, Japan.
authors.forename: Yasuhiro
authors.initials: Y
authors.lastname: Kawai
authors.affiliation: Department of Pediatrics, Kawasaki Medical School, Okayama, Japan.
authors.forename: Takaaki
authors.initials: T
authors.lastname: Tanaka
authors.affiliation: Department of Pediatrics, Kawasaki Medical School, Okayama, Japan.
authors.forename: Hiroto
authors.initials: H
authors.lastname: Akaike
authors.affiliation: Department of Pediatrics, Kawasaki Medical School, Okayama, Japan.
authors.forename: Hideto
authors.initials: H
authors.lastname: Teranishi
authors.affiliation: Department of Pediatrics, Kawasaki Medical School, Okayama, Japan.
authors.forename: Tokio
authors.initials: T
authors.lastname: Wakabayashi
authors.affiliation: Department of Pediatrics, Kawasaki Medical School, Okayama, Japan.
authors.forename: Takashi
authors.initials: T
authors.lastname: Nakano
authors.affiliation: Department of Pediatrics, Kawasaki Medical School, Okayama, Japan.
authors.forename: Kazunobu
authors.initials: K
authors.lastname: Ouchi
authors.affiliation: Department of Internal Medicine 1, Kawasaki Medical School, Okayama, Japan.
authors.forename: Niro
authors.initials: N
authors.lastname: Okimoto
mesh_terms: D000293:Adolescent; D000328:Adult; D000941:Antigens / Q000276:immunology*; D002648:Child; D002675:Child, Preschool; D017714:Community-Acquired Infections / Q000175:diagnosis; D005260:Female; D006801:Humans; D007118:Immunoassay / Q000379:methods*; D007223:Infant; D007231:Infant, Newborn; D007564:Japan; D008297:Male; D009177:Mycoplasma pneumoniae / Q000235:genetics / Q000276:immunology; D011019:Pneumonia, Mycoplasma / Q000175:diagnosis* / Q000276:immunology / Q000382:microbiology; D011446:Prospective Studies; D011933:Reagent Kits, Diagnostic; D060888:Real-Time Polymerase Chain Reaction / Q000379:methods*; D012141:Respiratory Tract Infections / Q000175:diagnosis; D012189:Retrospective Studies; D012680:Sensitivity and Specificity; D055815:Young Adult
chemical_list: D000941:Antigens; D011933:Reagent Kits, Diagnostic
keywords: Community-acquired pneumonia; Mycoplasma pneumoniae; Real-time polymerase chain reaction; Ribotest Mycoplasma; Sensitivity