Accuracy of Immunodiagnostic Tests for Active Tuberculosis Using Single and Combined Results: A Multicenter TBNET-Study

The clinical application of IFN-gamma release assays (IGRAs) has recently improved the diagnosis of latent tuberculosis infection. In a multicenter study of the Tuberculosis Network European Trialsgroup (TBNET) we aimed to ascertain in routine clinical practice the accuracy of a novel assay using se...

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Published in:PloS one Vol. 3; no. 10; p. e3417
Main Authors: Goletti, Delia, Stefania, Carrara, Butera, Ornella, Amicosante, Massimo, Ernst, Martin, Sauzullo, Ilaria, Vullo, Vincenzo, Cirillo, Daniela, Borroni, Emanuele, Markova, Roumiana, Drenska, Roumiana, Dominguez, José, Latorre, Irene, Angeletti, Claudio, Navarra, Assunta, Petrosillo, Nicola, Lauria, Francesco Nicola, Ippolito, Giuseppe, Migliori, Giovanni Battista, Lange, Christoph, Girardi, Enrico
Format: Journal Article
Language:English
Published: United States Public Library of Science 15.10.2008
Public Library of Science (PLoS)
Subjects:
Adult
Antigens
Antigens, Bacterial - analysis
Assaying
Blood tests
Clinical medicine
Diagnosis
Enzymes
Epidemiology
Female
Gold
Health aspects
Hospitals
Humans
Immune response
Immunologic Tests - methods
Immunologic Tests - standards
Immunology
Infections
Infectious Diseases
Infectious Diseases/Epidemiology and Control of Infectious Diseases
Infectious Diseases/Respiratory Infections
Interferon
Lymphocytes
Male
Medical diagnosis
Medical tests
Middle Aged
Mycobacterium tuberculosis
Mycobacterium tuberculosis - immunology
Pathogens
Peptides
Prospective Studies
Reproducibility of Results
Sensitivity
Sensitivity and Specificity
Skin tests
T cell receptors
Tropical diseases
Tuberculin
Tuberculin Test - standards
Tuberculosis
Tuberculosis - diagnosis
γ-Interferon
Italy
ISSN:1932-6203, 1932-6203
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Summary:The clinical application of IFN-gamma release assays (IGRAs) has recently improved the diagnosis of latent tuberculosis infection. In a multicenter study of the Tuberculosis Network European Trialsgroup (TBNET) we aimed to ascertain in routine clinical practice the accuracy of a novel assay using selected peptides encoded in the mycobacterial genomic region of difference (RD) 1 for the diagnosis of active tuberculosis in comparison with tuberculin skin test (TST), QuantiFERON-TB GOLD In-Tube (Cellestis Ltd., Carnegie, Australia) and T-SPOT.TB (Oxfordimmunotec, Abingdon, UK). 425 individuals from 6 different European centres were prospectively enrolled. We found that sensitivity of the novel test, TST, QuantiFERON-TB GOLD In-Tube and T-SPOT.TB was respectively 73.1%, 85.3%, 78.1%, and 85.2%; specificity was respectively 70.6%, 48.0%, 61.9% and 44.3%; positive likelihood ratios were respectively 2.48, 1.64, 2.05, and 1.53; negative likelihood ratios were respectively 0.38, 0.31, 0.35, 0.33. Sensitivity of TST combined with the novel test, QuantiFERON-TB GOLD In-Tube and T-SPOT.TB increased up to 92.4%, 97.7% and 97.1%, respectively. The likelihood ratios of combined negative results of TST with, respectively, the novel test, QuantiFERON-TB GOLD In-Tube and T-SPOT.TB were 0.19, 0.07 and 0.10. The assay based on RD1 selected peptides has similar accuracy for active tuberculosis compared with TST and commercial IGRAs. Then, independently of the spectrum of antigens used in the assays to elicit mycobacterial specific immune responses, the novel test, IGRAs, and the TST do not allow an accurate identification of active tuberculosis in clinical practice. However, the combined use of the novel assay or commercial IGRAs with TST may allow exclusion of tuberculosis.
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Conceived and designed the experiments: DG GBM CL EG. Performed the experiments: OB ME IS EB RHD JD IL. Analyzed the data: DG SC VV DMC RKM CA AN EG. Contributed reagents/materials/analysis tools: DG MA VV DMC RKM NP FNL GI. Wrote the paper: DG SC CA GBM CL EG.
ISSN:1932-6203
1932-6203
DOI:10.1371/journal.pone.0003417