Prospective comparison of the tuberculin skin test and 2 whole-blood interferon-γ release assays in persons with suspected tuberculosis

Gerald H. Mazurek, Stephen Weis, Patrick K. Moonan, Charles L. Daley, John Bernardo, Alfred A. Lardizabal, Randall R. Reves, Sean R. Toney, Laura J. Daniels, Philip A. LoBue

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Abstract

Background. Interferon-γ release assays (IGRAs) are attractive alternatives to the tuberculin skin test (TST) for detecting Mycobacterium tuberculosis infection. However, the inability to definitively confirm the presence of most M. tuberculosis infections hampers assessment of IGRA accuracy. Although IGRAs are primarily indicated for the detection of latent tuberculosis infection, we sought to determine the sensitivity of the TST and 2 whole-blood IGRAs (QuantiFERON-TB assay [QFT] and QuantiFERON-TB Gold assay [QFT-G]) in situations in which infection is confirmed by recovery of M. tuberculosis by culture. Methods. We conducted a prospective, multicenter, cross-sectional comparison study in which 148 persons suspected to have tuberculosis were tested simultaneously with the TST, QFT, and QFT-G. Results. M. tuberculosis was cultured fromsamples from 69 (47%) of 148 persons suspected to have tuberculosis; the TST induration was ≥5 mm for 51 (73.9%) of the 69 subjects (95% confidence interval [CI], 62.5%-82.8%). The QFT indicated tuberculosis infection for 48 (69.6%) of the 69 subjects (95% CI, 57.9%-79.2%) and was indeterminate for 7 (10.1%). The QFT-G yielded positive results for 46 (66.7%) of the 69 subjects (95% CI, 54.9%-76.7%) and indeterminate results for 9 subjects (13.0%). If subjects with indeterminate QFT-G results were excluded, 46 (76.7%) of 60 subjects (95% CI, 64.6%-85.6%) had positive TST results, and the same number of subjects had positive QFT-G results. HIV infection was associated with false-negative TST results but not with false-negative QFT-G results. Conclusions. The TST, QFT, and QFT-G have similar sensitivity in persons with culture-confirmed infection. As with the TST, negative QFT and QFT-G results should not be used to exclude the diagnosis of tuberculosis in persons with suggestive signs or symptoms.

Original languageEnglish
Pages (from-to)837-845
Number of pages9
JournalClinical Infectious Diseases
Volume45
Issue number7
DOIs
StatePublished - 22 Oct 2007

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Tuberculin Test
Skin Tests
Interferons
Tuberculosis
Mycobacterium tuberculosis
Confidence Intervals
Mycobacterium Infections
Infection
Latent Tuberculosis
Gold
Signs and Symptoms
HIV Infections
Cross-Sectional Studies

Cite this

Mazurek, Gerald H. ; Weis, Stephen ; Moonan, Patrick K. ; Daley, Charles L. ; Bernardo, John ; Lardizabal, Alfred A. ; Reves, Randall R. ; Toney, Sean R. ; Daniels, Laura J. ; LoBue, Philip A. / Prospective comparison of the tuberculin skin test and 2 whole-blood interferon-γ release assays in persons with suspected tuberculosis. In: Clinical Infectious Diseases. 2007 ; Vol. 45, No. 7. pp. 837-845.
@article{7d08ee2adfcf47c485d2bee2580c9290,
title = "Prospective comparison of the tuberculin skin test and 2 whole-blood interferon-γ release assays in persons with suspected tuberculosis",
abstract = "Background. Interferon-γ release assays (IGRAs) are attractive alternatives to the tuberculin skin test (TST) for detecting Mycobacterium tuberculosis infection. However, the inability to definitively confirm the presence of most M. tuberculosis infections hampers assessment of IGRA accuracy. Although IGRAs are primarily indicated for the detection of latent tuberculosis infection, we sought to determine the sensitivity of the TST and 2 whole-blood IGRAs (QuantiFERON-TB assay [QFT] and QuantiFERON-TB Gold assay [QFT-G]) in situations in which infection is confirmed by recovery of M. tuberculosis by culture. Methods. We conducted a prospective, multicenter, cross-sectional comparison study in which 148 persons suspected to have tuberculosis were tested simultaneously with the TST, QFT, and QFT-G. Results. M. tuberculosis was cultured fromsamples from 69 (47{\%}) of 148 persons suspected to have tuberculosis; the TST induration was ≥5 mm for 51 (73.9{\%}) of the 69 subjects (95{\%} confidence interval [CI], 62.5{\%}-82.8{\%}). The QFT indicated tuberculosis infection for 48 (69.6{\%}) of the 69 subjects (95{\%} CI, 57.9{\%}-79.2{\%}) and was indeterminate for 7 (10.1{\%}). The QFT-G yielded positive results for 46 (66.7{\%}) of the 69 subjects (95{\%} CI, 54.9{\%}-76.7{\%}) and indeterminate results for 9 subjects (13.0{\%}). If subjects with indeterminate QFT-G results were excluded, 46 (76.7{\%}) of 60 subjects (95{\%} CI, 64.6{\%}-85.6{\%}) had positive TST results, and the same number of subjects had positive QFT-G results. HIV infection was associated with false-negative TST results but not with false-negative QFT-G results. Conclusions. The TST, QFT, and QFT-G have similar sensitivity in persons with culture-confirmed infection. As with the TST, negative QFT and QFT-G results should not be used to exclude the diagnosis of tuberculosis in persons with suggestive signs or symptoms.",
author = "Mazurek, {Gerald H.} and Stephen Weis and Moonan, {Patrick K.} and Daley, {Charles L.} and John Bernardo and Lardizabal, {Alfred A.} and Reves, {Randall R.} and Toney, {Sean R.} and Daniels, {Laura J.} and LoBue, {Philip A.}",
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doi = "10.1086/521107",
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Mazurek, GH, Weis, S, Moonan, PK, Daley, CL, Bernardo, J, Lardizabal, AA, Reves, RR, Toney, SR, Daniels, LJ & LoBue, PA 2007, 'Prospective comparison of the tuberculin skin test and 2 whole-blood interferon-γ release assays in persons with suspected tuberculosis', Clinical Infectious Diseases, vol. 45, no. 7, pp. 837-845. https://doi.org/10.1086/521107

Prospective comparison of the tuberculin skin test and 2 whole-blood interferon-γ release assays in persons with suspected tuberculosis. / Mazurek, Gerald H.; Weis, Stephen; Moonan, Patrick K.; Daley, Charles L.; Bernardo, John; Lardizabal, Alfred A.; Reves, Randall R.; Toney, Sean R.; Daniels, Laura J.; LoBue, Philip A.

In: Clinical Infectious Diseases, Vol. 45, No. 7, 22.10.2007, p. 837-845.

Research output: Contribution to journalArticleResearchpeer-review

TY - JOUR

T1 - Prospective comparison of the tuberculin skin test and 2 whole-blood interferon-γ release assays in persons with suspected tuberculosis

AU - Mazurek, Gerald H.

AU - Weis, Stephen

AU - Moonan, Patrick K.

AU - Daley, Charles L.

AU - Bernardo, John

AU - Lardizabal, Alfred A.

AU - Reves, Randall R.

AU - Toney, Sean R.

AU - Daniels, Laura J.

AU - LoBue, Philip A.

PY - 2007/10/22

Y1 - 2007/10/22

N2 - Background. Interferon-γ release assays (IGRAs) are attractive alternatives to the tuberculin skin test (TST) for detecting Mycobacterium tuberculosis infection. However, the inability to definitively confirm the presence of most M. tuberculosis infections hampers assessment of IGRA accuracy. Although IGRAs are primarily indicated for the detection of latent tuberculosis infection, we sought to determine the sensitivity of the TST and 2 whole-blood IGRAs (QuantiFERON-TB assay [QFT] and QuantiFERON-TB Gold assay [QFT-G]) in situations in which infection is confirmed by recovery of M. tuberculosis by culture. Methods. We conducted a prospective, multicenter, cross-sectional comparison study in which 148 persons suspected to have tuberculosis were tested simultaneously with the TST, QFT, and QFT-G. Results. M. tuberculosis was cultured fromsamples from 69 (47%) of 148 persons suspected to have tuberculosis; the TST induration was ≥5 mm for 51 (73.9%) of the 69 subjects (95% confidence interval [CI], 62.5%-82.8%). The QFT indicated tuberculosis infection for 48 (69.6%) of the 69 subjects (95% CI, 57.9%-79.2%) and was indeterminate for 7 (10.1%). The QFT-G yielded positive results for 46 (66.7%) of the 69 subjects (95% CI, 54.9%-76.7%) and indeterminate results for 9 subjects (13.0%). If subjects with indeterminate QFT-G results were excluded, 46 (76.7%) of 60 subjects (95% CI, 64.6%-85.6%) had positive TST results, and the same number of subjects had positive QFT-G results. HIV infection was associated with false-negative TST results but not with false-negative QFT-G results. Conclusions. The TST, QFT, and QFT-G have similar sensitivity in persons with culture-confirmed infection. As with the TST, negative QFT and QFT-G results should not be used to exclude the diagnosis of tuberculosis in persons with suggestive signs or symptoms.

AB - Background. Interferon-γ release assays (IGRAs) are attractive alternatives to the tuberculin skin test (TST) for detecting Mycobacterium tuberculosis infection. However, the inability to definitively confirm the presence of most M. tuberculosis infections hampers assessment of IGRA accuracy. Although IGRAs are primarily indicated for the detection of latent tuberculosis infection, we sought to determine the sensitivity of the TST and 2 whole-blood IGRAs (QuantiFERON-TB assay [QFT] and QuantiFERON-TB Gold assay [QFT-G]) in situations in which infection is confirmed by recovery of M. tuberculosis by culture. Methods. We conducted a prospective, multicenter, cross-sectional comparison study in which 148 persons suspected to have tuberculosis were tested simultaneously with the TST, QFT, and QFT-G. Results. M. tuberculosis was cultured fromsamples from 69 (47%) of 148 persons suspected to have tuberculosis; the TST induration was ≥5 mm for 51 (73.9%) of the 69 subjects (95% confidence interval [CI], 62.5%-82.8%). The QFT indicated tuberculosis infection for 48 (69.6%) of the 69 subjects (95% CI, 57.9%-79.2%) and was indeterminate for 7 (10.1%). The QFT-G yielded positive results for 46 (66.7%) of the 69 subjects (95% CI, 54.9%-76.7%) and indeterminate results for 9 subjects (13.0%). If subjects with indeterminate QFT-G results were excluded, 46 (76.7%) of 60 subjects (95% CI, 64.6%-85.6%) had positive TST results, and the same number of subjects had positive QFT-G results. HIV infection was associated with false-negative TST results but not with false-negative QFT-G results. Conclusions. The TST, QFT, and QFT-G have similar sensitivity in persons with culture-confirmed infection. As with the TST, negative QFT and QFT-G results should not be used to exclude the diagnosis of tuberculosis in persons with suggestive signs or symptoms.

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DO - 10.1086/521107

M3 - Article

VL - 45

SP - 837

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JO - Clinical Infectious Diseases

JF - Clinical Infectious Diseases

SN - 1058-4838

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