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Use in routine clinical practice of two commercial blood tests for diagnosis of infection with Mycobacterium tuberculosis: a prospective study

Use in routine clinical practice of two commercial blood tests for diagnosis of infection with Mycobacterium tuberculosis: a prospective study
Use in routine clinical practice of two commercial blood tests for diagnosis of infection with Mycobacterium tuberculosis: a prospective study
Background

Two commercial blood assays for the diagnosis of latent tuberculosis infection—T-SPOT.TB and QuantiFERON-TB Gold—have been separately compared with the tuberculin skin test. Our aim was to compare the efficacy of all three tests in the same population sample.

Methods

We did a prospective study in 393 consecutively enrolled patients who were tested simultaneously with T-SPOT.TB and QuantiFERON-TB Gold because of suspected latent or active tuberculosis. 318 patients also had results available for a tuberculin skin test.

Findings

Overall agreement with the skin test was similar (T-SPOT.TB ?=0·508, QuantiFERON-TB Gold ?=0·460), but fewer BCG-vaccinated individuals were identified as positive by the two blood assays than by the tuberculin skin test (p=0·003 for T-SPOT.TB and p<0.0001 for QuantiFERON-TB Gold). Indeterminate results were significantly more frequent with QuantiFERON-TB Gold (11%, 43 of 383) than with T-SPOT.TB (3%, 12 of 383; p<0·0001) and were associated with immunosuppressive treatments for both tests. Age younger than 5 years was significantly associated with indeterminate results with QuantiFERON-TB Gold (p=0.003), but not with T-SPOT.TB. Overall, T-SPOT.TB produced significantly more positive results (38%, n=144, vs 26%, n=100, with QuantiFERON-TB Gold; p<0·0001), and close contacts of patients with active tuberculosis were more likely to be positive with T-SPOT.TB than with QuantiFERON-TB Gold (p=0·0010).

Interpretation

T-SPOT.TB and QuantiFERON-TB Gold have higher specificity than the tuberculin skin test. Rates of indeterminate and positive results, however, differ between the blood tests, suggesting that they might provide different results in routine clinical practice.
0140-6736
1328-34
Ferrara, Giovanni
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Losi, Monica
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D'Amico, Roberto
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Roversi, Pietro
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Piro, Roberto
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Meacci, Marisa
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Meccugni, Barbara
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Dori, Ilaria Marchetti
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Andreani, Alessandro
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Bergamini, Barbara Maria
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Mussini, Cristina
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Rumpianesi, Fabio
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Fabbri, Leonardo M.
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Richeldi, Luca
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Ferrara, Giovanni
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Losi, Monica
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D'Amico, Roberto
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Roversi, Pietro
bb4e8839-5d4e-436a-bec6-7a3f7cd47f8b
Piro, Roberto
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Meacci, Marisa
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Meccugni, Barbara
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Dori, Ilaria Marchetti
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Andreani, Alessandro
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Bergamini, Barbara Maria
534ef375-cc9c-4ec7-bcb2-a4db967a1620
Mussini, Cristina
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Rumpianesi, Fabio
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Fabbri, Leonardo M.
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Richeldi, Luca
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Ferrara, Giovanni, Losi, Monica, D'Amico, Roberto, Roversi, Pietro, Piro, Roberto, Meacci, Marisa, Meccugni, Barbara, Dori, Ilaria Marchetti, Andreani, Alessandro, Bergamini, Barbara Maria, Mussini, Cristina, Rumpianesi, Fabio, Fabbri, Leonardo M. and Richeldi, Luca (2006) Use in routine clinical practice of two commercial blood tests for diagnosis of infection with Mycobacterium tuberculosis: a prospective study. The Lancet, 367 (9519), 1328-34. (doi:10.1016/S0140-6736(06)68579-6). (PMID:16631911)

Record type: Article

Abstract

Background

Two commercial blood assays for the diagnosis of latent tuberculosis infection—T-SPOT.TB and QuantiFERON-TB Gold—have been separately compared with the tuberculin skin test. Our aim was to compare the efficacy of all three tests in the same population sample.

Methods

We did a prospective study in 393 consecutively enrolled patients who were tested simultaneously with T-SPOT.TB and QuantiFERON-TB Gold because of suspected latent or active tuberculosis. 318 patients also had results available for a tuberculin skin test.

Findings

Overall agreement with the skin test was similar (T-SPOT.TB ?=0·508, QuantiFERON-TB Gold ?=0·460), but fewer BCG-vaccinated individuals were identified as positive by the two blood assays than by the tuberculin skin test (p=0·003 for T-SPOT.TB and p<0.0001 for QuantiFERON-TB Gold). Indeterminate results were significantly more frequent with QuantiFERON-TB Gold (11%, 43 of 383) than with T-SPOT.TB (3%, 12 of 383; p<0·0001) and were associated with immunosuppressive treatments for both tests. Age younger than 5 years was significantly associated with indeterminate results with QuantiFERON-TB Gold (p=0.003), but not with T-SPOT.TB. Overall, T-SPOT.TB produced significantly more positive results (38%, n=144, vs 26%, n=100, with QuantiFERON-TB Gold; p<0·0001), and close contacts of patients with active tuberculosis were more likely to be positive with T-SPOT.TB than with QuantiFERON-TB Gold (p=0·0010).

Interpretation

T-SPOT.TB and QuantiFERON-TB Gold have higher specificity than the tuberculin skin test. Rates of indeterminate and positive results, however, differ between the blood tests, suggesting that they might provide different results in routine clinical practice.

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More information

Published date: 22 April 2006
Organisations: Clinical & Experimental Sciences

Identifiers

Local EPrints ID: 368963
URI: http://eprints.soton.ac.uk/id/eprint/368963
ISSN: 0140-6736
PURE UUID: f23e2fd2-5254-49f2-8352-9451c0f73bf0

Catalogue record

Date deposited: 10 Oct 2014 13:07
Last modified: 14 Mar 2024 17:56

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Contributors

Author: Giovanni Ferrara
Author: Monica Losi
Author: Roberto D'Amico
Author: Pietro Roversi
Author: Roberto Piro
Author: Marisa Meacci
Author: Barbara Meccugni
Author: Ilaria Marchetti Dori
Author: Alessandro Andreani
Author: Barbara Maria Bergamini
Author: Cristina Mussini
Author: Fabio Rumpianesi
Author: Leonardo M. Fabbri
Author: Luca Richeldi

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