title: T-SPOT.TB: an in vitro diagnostic assay measuring T-cell reaction to Mycobacterium tuberculosis-specific antigens.
abstract: The overall sensitivity of the RD1 ELISPOT assay (T-SPO.TB), which counts T cells sensitized to specific Mycobacterium tuberculosis peptide sequences, was 81-97% in populations with confirmed tuberculosis, in whom 39-78% had immunosuppressive conditions. In patients with confirmed tuberculosis, the respective RD1 ELISPOT versus tuberculin skin test (TST) sensitivities were 100% versus 89% in adults and 77% versus 35% in children (of whom 39% were HIV-positive). In contrast to that of the TST, the sensitivity of the RD1 ELISPOT assay was not significantly affected by age <36 months, or the immunological or nutritional status of the subjects. Specificity was 100% in two UK-based studies. Isolated false positives have been recorded in patients infected with non-tuberculous M. kansasii. A study investigating latent tuberculosis infection found no significant difference in results between HIV-positive and -negative participants for the RD1 ELISPOT assay, while the TST varied significantly with HIV status. Contact-tracing studies have demonstrated concordance between the RD1 ELISPOT assay and the TST of 65-89%. There is a significant correlation between a positive result and the degree of exposure to the index case for the RD1 ELISPOT assay, but not for the TST, in contact-tracing studies. Unlike the TST, the RD1 ELISPOT assay is not confounded by bacille Calmette-Guérin vaccination.
authors.affiliation: Adis International Inc., Yardley, Pennsylvania 19067, USA. demail@adis.com
authors.forename: Antona J
authors.initials: AJ
authors.lastname: Wagstaff
authors.forename: Jean-Pierre
authors.initials: JP
authors.lastname: Zellweger
mesh_terms: D000942:Antigens, Bacterial / Q000276:immunology*; D016358:Contact Tracing; D006801:Humans; D009169:Mycobacterium tuberculosis / Q000276:immunology*; D011933:Reagent Kits, Diagnostic; D012680:Sensitivity and Specificity; D012882:Skin Tests; D013601:T-Lymphocytes / Q000276:immunology*; D014373:Tuberculin; D014376:Tuberculosis / Q000175:diagnosis* / Q000276:immunology*
chemical_list: D000942:Antigens, Bacterial; D011933:Reagent Kits, Diagnostic; D014373:Tuberculin; C072681:Mycobacterium tuberculosis antigens