Estimating diagnostic accuracy of tests for latent tuberculosis infection without a gold standard among healthcare workers.

E. Girardi, C. Angeletti, V. Puro, R. Sorrentino, N. Magnavita, D. Vincenti, S. Carrara, O. Butera, A. M. Ciufoli, S. Squarcione, G. Ippolito, D. Goletti

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Abstract

The evaluation of diagnostic accuracy of new in vitro diagnostic assays for tuberculosis infection has been hampered by the lack of a standard reference test. The aim of this study was to compare sensitivity and specificity of interferon gamma assays for latent tuberculosis infection by assessing the association of test results with tuberculosis occupational exposure and by using latent class analysis. We analysed data from 115 healthcare workers on whom tuberculin skin test (TST) and the following in vitro tests were performed: in-house ELISPOT for RD1 proteins, T.SPOT-TB and Quantiferon-TB Gold. Results of all tests were associated with increased occupational risk of exposure to Mycobacterium tuberculosis, but only TST was associated with Bacillus Calmette-Guerin (BCG) vaccination. Sensitivity/specificity (95% confidence intervals) estimated by a latent class model were: 99.9%/64.2% (53.0-74.1) for TST, 95.3% (61.8-99.6)/87.5% (78.0-93.2) for in-house ELISPOT, 96.7% (69.3-99.7)/85.6%(75.3-92.0) for T.SPOT-TB, and 76.3% (55.9-89.1)/93.6% (85.4-97.3) for Quantiferon. The estimated specificity of in vitro assays was higher than that of TST also among individuals who were not BCG-vaccinated. In conclusion, when used in healthcare workers, in vitro assays may provide a significant increase of specificity for tuberculosis infection compared to TST, even among non vaccinated individuals, at the cost of some sensitivity.

Original languageEnglish
JournalEuro surveillance : bulletin européen sur les maladies transmissibles = European communicable disease bulletin
Volume14
Issue number43
Publication statusPublished - 2009

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Latent Tuberculosis
Tuberculin Test
Skin Tests
Routine Diagnostic Tests
Delivery of Health Care
Enzyme-Linked Immunospot Assay
Tuberculosis
Occupational Exposure
Mycobacterium bovis
Sensitivity and Specificity
Infection
Mycobacterium tuberculosis
Gold
Interferon-gamma
Vaccination
Confidence Intervals
In Vitro Techniques
Proteins

ASJC Scopus subject areas

  • Medicine(all)

Cite this

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title = "Estimating diagnostic accuracy of tests for latent tuberculosis infection without a gold standard among healthcare workers.",
abstract = "The evaluation of diagnostic accuracy of new in vitro diagnostic assays for tuberculosis infection has been hampered by the lack of a standard reference test. The aim of this study was to compare sensitivity and specificity of interferon gamma assays for latent tuberculosis infection by assessing the association of test results with tuberculosis occupational exposure and by using latent class analysis. We analysed data from 115 healthcare workers on whom tuberculin skin test (TST) and the following in vitro tests were performed: in-house ELISPOT for RD1 proteins, T.SPOT-TB and Quantiferon-TB Gold. Results of all tests were associated with increased occupational risk of exposure to Mycobacterium tuberculosis, but only TST was associated with Bacillus Calmette-Guerin (BCG) vaccination. Sensitivity/specificity (95{\%} confidence intervals) estimated by a latent class model were: 99.9{\%}/64.2{\%} (53.0-74.1) for TST, 95.3{\%} (61.8-99.6)/87.5{\%} (78.0-93.2) for in-house ELISPOT, 96.7{\%} (69.3-99.7)/85.6{\%}(75.3-92.0) for T.SPOT-TB, and 76.3{\%} (55.9-89.1)/93.6{\%} (85.4-97.3) for Quantiferon. The estimated specificity of in vitro assays was higher than that of TST also among individuals who were not BCG-vaccinated. In conclusion, when used in healthcare workers, in vitro assays may provide a significant increase of specificity for tuberculosis infection compared to TST, even among non vaccinated individuals, at the cost of some sensitivity.",
author = "E. Girardi and C. Angeletti and V. Puro and R. Sorrentino and N. Magnavita and D. Vincenti and S. Carrara and O. Butera and Ciufoli, {A. M.} and S. Squarcione and G. Ippolito and D. Goletti",
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AU - Girardi, E.

AU - Angeletti, C.

AU - Puro, V.

AU - Sorrentino, R.

AU - Magnavita, N.

AU - Vincenti, D.

AU - Carrara, S.

AU - Butera, O.

AU - Ciufoli, A. M.

AU - Squarcione, S.

AU - Ippolito, G.

AU - Goletti, D.

PY - 2009

Y1 - 2009

N2 - The evaluation of diagnostic accuracy of new in vitro diagnostic assays for tuberculosis infection has been hampered by the lack of a standard reference test. The aim of this study was to compare sensitivity and specificity of interferon gamma assays for latent tuberculosis infection by assessing the association of test results with tuberculosis occupational exposure and by using latent class analysis. We analysed data from 115 healthcare workers on whom tuberculin skin test (TST) and the following in vitro tests were performed: in-house ELISPOT for RD1 proteins, T.SPOT-TB and Quantiferon-TB Gold. Results of all tests were associated with increased occupational risk of exposure to Mycobacterium tuberculosis, but only TST was associated with Bacillus Calmette-Guerin (BCG) vaccination. Sensitivity/specificity (95% confidence intervals) estimated by a latent class model were: 99.9%/64.2% (53.0-74.1) for TST, 95.3% (61.8-99.6)/87.5% (78.0-93.2) for in-house ELISPOT, 96.7% (69.3-99.7)/85.6%(75.3-92.0) for T.SPOT-TB, and 76.3% (55.9-89.1)/93.6% (85.4-97.3) for Quantiferon. The estimated specificity of in vitro assays was higher than that of TST also among individuals who were not BCG-vaccinated. In conclusion, when used in healthcare workers, in vitro assays may provide a significant increase of specificity for tuberculosis infection compared to TST, even among non vaccinated individuals, at the cost of some sensitivity.

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