title: Interferon-γ release assays for the diagnosis of active tuberculosis: a systematic review and meta-analysis.
abstract: Interferon-γ release assays (IGRAs) are now established for the immunodiagnosis of latent infection with Mycobacterium tuberculosis in many countries. However, the role of IGRAs for the diagnosis of active tuberculosis (TB) remains unclear. Following preferred reporting items for systematic reviews and meta-analyses (PRISMA) and quality assessment of diagnostic accuracy studies (QUADAS) guidelines, we searched PubMed, EMBASE and Cochrane databases to identify studies published in January 2001-November 2009 that evaluated the evidence of using QuantiFERON-TB® Gold in-tube (QFT-G-IT) and T-SPOT.TB® directly on blood or extrasanguinous specimens for the diagnosis of active TB. The literature search yielded 844 studies and 27 met the inclusion criteria. In blood and extrasanguinous fluids, the pooled sensitivity for the diagnosis of active TB was 80% (95% CI 75-84%) and 48% (95% CI 39-58%) for QFT-G-IT, and 81% (95% CI 78-84%) and 88% (confirmed and unconfirmed cases) (95% CI 82-92%) for T-SPOT.TB®, respectively. In blood and extrasanguinous fluids, the pooled specificity was 79% (95% CI 75-82%) and 82% (95% CI 70-91%) for QFT-G-IT, and 59% (95% CI 56-62%) and 82% (95% CI 78-86%) for T-SPOT.TB®, respectively. Although the diagnostic sensitivities of both IGRAs were higher than that of tuberculin skin tests, it was still not high enough to use as a rule out test for TB. Positive evidence for the use of IGRAs in compartments other than blood will require more independent and carefully designed prospective studies.
authors.affiliation: Dept of Transplant and Infection Immunology, Saarland University, Homburg, Germany.
authors.forename: M
authors.initials: M
authors.lastname: Sester
authors.forename: G
authors.initials: G
authors.lastname: Sotgiu
authors.forename: C
authors.initials: C
authors.lastname: Lange
authors.forename: C
authors.initials: C
authors.lastname: Giehl
authors.forename: E
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authors.lastname: Girardi
authors.forename: G B
authors.initials: GB
authors.lastname: Migliori
authors.forename: A
authors.initials: A
authors.lastname: Bossink
authors.forename: K
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authors.lastname: Dheda
authors.forename: R
authors.initials: R
authors.lastname: Diel
authors.forename: J
authors.initials: J
authors.lastname: Dominguez
authors.forename: M
authors.initials: M
authors.lastname: Lipman
authors.forename: J
authors.initials: J
authors.lastname: Nemeth
authors.forename: P
authors.initials: P
authors.lastname: Ravn
authors.forename: S
authors.initials: S
authors.lastname: Winkler
authors.forename: E
authors.initials: E
authors.lastname: Huitric
authors.forename: A
authors.initials: A
authors.lastname: Sandgren
authors.forename: D
authors.initials: D
authors.lastname: Manissero
mesh_terms: D000328:Adult; D000465:Algorithms; D002648:Child; D002986:Clinical Trials as Topic; D006801:Humans; D007371:Interferon-gamma / Q000378:metabolism*; D015999:Multivariate Analysis; D009164:Mycobacterium Infections / Q000175:diagnosis* / Q000382:microbiology*; D009169:Mycobacterium tuberculosis / Q000378:metabolism*; D016017:Odds Ratio; D011237:Predictive Value of Tests; D011933:Reagent Kits, Diagnostic; D015203:Reproducibility of Results; D014374:Tuberculin Test; D014376:Tuberculosis / Q000175:diagnosis* / Q000382:microbiology*
chemical_list: D011933:Reagent Kits, Diagnostic; D007371:Interferon-gamma