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1 October 2007

Volume 45, Number 7
Clinical Infectious Diseases 2007;45:837–845
© 2007 by the Infectious Diseases Society of America. All rights reserved.
1058-4838/2007/4507-0003$15.00
DOI: 10.1086/521107
MAJOR ARTICLE

Prospective Comparison of the Tuberculin Skin Test and 2 Whole‐Blood Interferon‐γ Release Assays in Persons with Suspected Tuberculosis

Gerald H. Mazurek,1,2

Stephen E. Weis,3,4

Patrick K. Moonan,1,3,4

Charles L. Daley,5,a

John Bernardo,6

Alfred A. Lardizabal,7

Randall R. Reves,8

Sean R. Toney,1

Laura J. Daniels,1 and

Philip A. LoBue1

1Division of Tuberculosis Elimination, Centers for Disease Control and Prevention, and 2Pulmonary and Critical Care Division, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia, 3University of North Texas Health Science Center and 4Tarrant County Public Health, Fort Worth, Texas, 5University of California, San Francisco, 6Boston University School of Medicine, Boston, Massachusetts, 7New Jersey Medical School National Tuberculosis Center, Newark, and 8Denver Public Health Department, Denver, Colorado

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 from samples 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.

Received 9 December 2006; accepted 29 March 2007; electronically published 24 August 2007.

Reprints or correspondence: Dr. Gerald Mazurek, Centers for Disease Control and Prevention, MS E10, 1600 Clifton Rd., Atlanta, GA 30333 ().

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  • Present affiliation: National Jewish Medical and Research Center, Denver, Colorado (C.L.D.).

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