title: Validation of a commercial serodiagnostic kit for diagnosing pulmonary Mycobacterium avium complex disease.
abstract: METHODS
  A commercial serodiagnostic kit for diagnosing pulmonary disease due to Mycobacterium avium complex (MAC-PD) was developed and launched in Japan in 2011.
  
  
  OBJECTIVE
  To evaluate the performance of this kit in routine clinical settings.
  
  
  METHODS
  In this retrospective single-centre study, data on serum levels of anti-glycopeptidolipid (GPL) core IgA antibody (U/ml) measured using the kit were analysed in patients diagnosed with MAC-PD according to American Thoracic Society criteria, in those with pulmonary tuberculosis (PTB) or pulmonary M. kansasii disease and in healthy volunteers.
  
  
  RESULTS
  The anti-GPL-core IgA antibody levels of serum were significantly higher (P < 0.0001) in patients with MAC-PD (n = 485) than in those with PTB (n = 133) or pulmonary M. kansasii disease (n = 23) or in healthy subjects (n = 265). When the cut-off level was set at 0.7 U/ml, the sensitivity and specificity were respectively 78.6% and 96.9%. Higher antibody levels were observed in patients with greater extent of disease on chest computed tomography (P < 0.0001).
  
  
  CONCLUSIONS
  The serodiagnostic kit revealed good sensitivity and specificity. The antibody levels may reflect disease activity. Additional work is needed to determine whether the diagnostic assay could be used in conjunction with current diagnostic criteria to improve the diagnosis of MAC-PD.
authors.affiliation: Department of Respiratory Medicine, National Hospital Organization, National Toneyama Hospital, Osaka, Japan.
authors.forename: S
authors.initials: S
authors.lastname: Kitada
authors.affiliation: Department of Respiratory Medicine, National Hospital Organization, National Toneyama Hospital, Osaka, Japan.
authors.forename: K
authors.initials: K
authors.lastname: Yoshimura
authors.affiliation: Department of Respiratory Medicine, National Hospital Organization, National Toneyama Hospital, Osaka, Japan.
authors.forename: K
authors.initials: K
authors.lastname: Miki
authors.affiliation: Department of Respiratory Medicine, National Hospital Organization, National Toneyama Hospital, Osaka, Japan.
authors.forename: M
authors.initials: M
authors.lastname: Miki
authors.affiliation: Department of Respiratory Medicine, National Hospital Organization, National Toneyama Hospital, Osaka, Japan.
authors.forename: H
authors.initials: H
authors.lastname: Hashimoto
authors.affiliation: Department of Respiratory Medicine, National Hospital Organization, National Toneyama Hospital, Osaka, Japan.
authors.forename: H
authors.initials: H
authors.lastname: Matsui
authors.affiliation: Department of Respiratory Medicine, National Hospital Organization, National Toneyama Hospital, Osaka, Japan.
authors.forename: M
authors.initials: M
authors.lastname: Kuroyama
authors.affiliation: Department of Respiratory Medicine, National Hospital Organization, National Toneyama Hospital, Osaka, Japan.
authors.forename: F
authors.initials: F
authors.lastname: Ageshio
authors.affiliation: Department of Respiratory Medicine, National Hospital Organization, National Toneyama Hospital, Osaka, Japan.
authors.forename: H
authors.initials: H
authors.lastname: Kagawa
authors.affiliation: Department of Respiratory Medicine, National Hospital Organization, National Toneyama Hospital, Osaka, Japan.
authors.forename: M
authors.initials: M
authors.lastname: Mori
authors.affiliation: Department of Respiratory Medicine, National Hospital Organization, National Toneyama Hospital, Osaka, Japan.
authors.forename: R
authors.initials: R
authors.lastname: Maekura
authors.affiliation: Sakai City Institute of Public Health, Osaka, Japan.
authors.forename: K
authors.initials: K
authors.lastname: Kobayashi
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000907:Antibodies, Bacterial / Q000097:blood; D000942:Antigens, Bacterial / Q000097:blood; D005260:Female; D006001:Glycoconjugates / Q000097:blood; D006801:Humans; D007070:Immunoglobulin A / Q000097:blood; D007564:Japan; D008297:Male; D008875:Middle Aged; D015269:Mycobacterium avium Complex / Q000302:isolation & purification*; D015270:Mycobacterium avium-intracellulare Infection / Q000175:diagnosis*; D012189:Retrospective Studies; D012680:Sensitivity and Specificity; D013183:Sputum / Q000382:microbiology; D014057:Tomography, X-Ray Computed
chemical_list: D000907:Antibodies, Bacterial; D000942:Antigens, Bacterial; D006001:Glycoconjugates; D007070:Immunoglobulin A