title: Evaluation of a commercially available serologic assay for antibodies against tuberculosis-associated glycolipid antigen.
abstract: A commercially available enzyme immunoassay developed to detect antibodies to a tuberculosis-associated glycolipid antigen was evaluated for serologic diagnosis of tuberculosis. This was a multicenter study comparing the assay with other methods in 78 patients with active pulmonary tuberculosis and in 54 controls with non-tuberculous lung diseases. Sensitivities were highest for sputum culture (91.0%), followed by immunoassay (79.5%), nucleic acid amplification (77.3%), and finally acid-fast staining of sputum smear (60.3%). Immunoassay and amplification, both rapid methods, had similarly high sensitivity in smear-positive subjects (89.4 and 88.9%, respectively); in smear-negative subjects these two techniques showed low sensitivity (64.5 and 60.0%, respectively). Concordance between the two methods was relatively low (72.0%). With regard to specificity, seven out of ten patients with old tuberculosis had positive result by immunoassay (30% specificity). In the control group, 10 out of 54 patients had positive immunoassay result (72.2% specificity), with notably limited specificity in the elderly. The tuberculous glycolipid assay is a rapid method sufficiently sensitive for detection of tuberculosis infection, even in smear-negative patients.
authors.affiliation: Department of Clinical Laboratory, Nagoya University Hospital, Nagoya-city, Japan. yiinuma@med.nagoya-u.ac.jp
authors.forename: Yoshitsugu
authors.initials: Y
authors.lastname: Iinuma
authors.forename: Kazuyoshi
authors.initials: K
authors.lastname: Senda
authors.forename: Shunji
authors.initials: S
authors.lastname: Takakura
authors.forename: Satoshi
authors.initials: S
authors.lastname: Ichiyama
authors.forename: Masao
authors.initials: M
authors.lastname: Tano
authors.forename: Tomoji
authors.initials: T
authors.lastname: Abe
authors.forename: Tomoko
authors.initials: T
authors.lastname: Yamamoto
authors.forename: Kazumitsu
authors.initials: K
authors.lastname: Nakashima
authors.forename: Hisashi
authors.initials: H
authors.lastname: Baba
authors.forename: Yoshinori
authors.initials: Y
authors.lastname: Hasegawa
authors.forename: Kaoru
authors.initials: K
authors.lastname: Shimokata
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000907:Antibodies, Bacterial / Q000097:blood*; D000942:Antigens, Bacterial / Q000276:immunology; D016022:Case-Control Studies; D003951:Diagnostic Errors; D006017:Glycolipids / Q000276:immunology; D006801:Humans; D007118:Immunoassay / Q000592:standards; D008875:Middle Aged; D009169:Mycobacterium tuberculosis / Q000276:immunology*; D011933:Reagent Kits, Diagnostic / Q000592:standards; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D014397:Tuberculosis, Pulmonary / Q000097:blood / Q000175:diagnosis*
chemical_list: D000907:Antibodies, Bacterial; D000942:Antigens, Bacterial; D006017:Glycolipids; D011933:Reagent Kits, Diagnostic