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Clinical and Vaccine Immunology, January 2006, p. 53-58, Vol. 13, No. 1
1071-412X/06/$08.00+0     doi:10.1128/CVI.13.1.53-58.2006
Copyright © 2006, American Society for Microbiology. All Rights Reserved.

Comparison of a New ESAT-6/CFP-10 Peptide-Based Gamma Interferon Assay and a Tuberculin Skin Test for Tuberculosis Screening in a Moderate-Risk Population

Department of Family and Community Medicine, The University of Texas Health Science Center, Houston, Texas,¹ Division of Environmental and Occupational Health, The University of Texas School of Public Health, Houston, Texas,² Center for Human Bacterial Pathogenesis Research, Department of Pathology, Baylor College of Medicine, Houston, Texas,³ Department of Medicine, Baylor College of Medicine, Houston, Texas⁴

Received 8 September 2005/ Returned for modification 20 October 2005/ Accepted 1 November 2005

Screening for latent tuberculosis infection (LTBI) with Mantoux tuberculin skin test (TST) has many limitations, including false-positive results due to exposure to Mycobacterium other than tuberculosis (TB) and BCG vaccination. A total of 474 adult inmates in a county jail were screened for LTBI using TST and a new ESAT-6/CFP-10 peptide-based whole-blood gamma interferon (IFN-) assay. LTBI prevalence was 9.0 and 5.4% as determined by TST and IFN- assay, respectively. Overall, agreement between test results was 90% ( = 0.25). Positive TST results were significantly associated with increased age (odds ratio [OR], 1.04; 95% confidence interval [CI], 1.01 to 1.08), African-American ethnicity (OR, 4.97; 95% CI, 1.58 to 15.68), foreign birth (OR, 20.20; 95% CI, 4.21 to 97.02) and prior incarceration (OR, 6.19; 95% CI, 1.48 to 25.95). Positive IFN- assay results were significantly associated with African-American ethnicity (OR, 5.58; 95% CI, 1.16 to 26.74). Factors associated with statistically significant discordance between TST and IFN- assay results were African-American ethnicity (OR, 0.29; 95% CI, 0.11 to 0.77), foreign birth (OR, 0.23; 95% CI, 0.07-0.80), and prior incarceration (OR, 0.06; 95% CI, 0.01-0.50). Among subjects born in the United States, African-American ethnicity was the only variable significantly associated with positive test results for both TST (OR, 4.26; 95% CI, 1.38 to 13.16) and IFN- assay (OR, 5.74; 95% CI, 1.19 to 27.75) and remained associated with statistically significant discordance between TST and IFN- assay results. The reactivity of the new IFN- assay is unaffected by prior BCG vaccination or serial TSTs but may be diminished in African-Americans. Future longitudinal studies are needed to assess the sensitivity and specificity of this new assay in detecting LTBI.

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