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Published ahead of print on December 14, 2006, doi:10.1164/rccm.200608-1099OC

Am. J. Respir. Crit. Care Med., Volume 175, Number 6, March 2007, 618-627

A more recent version of this article appeared on March 15, 2007
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Submitted on August 6, 2006
Accepted on December 14, 2006

Comparison of Two Interferon-Gamma Assays and Tuberculin Skin Test for Tracing TB Contacts

Sandra M Arend1, Steven FT Thijsen2, Eliane MS Leyten1, John JM Bouwman2, Willeke PJ Franken1, Ben FPJ Koster3, Frank GJ Cobelens4, Arend-Jan van Houte5, and Ailko WJ Bossink6*

1 Department of Infectious Diseases, Leiden University Medical Center, Leiden, The Netherlands, 2 Department of Medical Microbiology and Immunology, Diakonessenhuis Utrecht, Utrecht, The Netherlands, 3 Department of Tuberculosis Control, Municipal Health Authority, Utrecht, The Netherlands, 4 KNCV Tuberculosis Foundation, The Hague, The Netherlands; Centre for Infection and Immunity Amsterdam, Academisch Medisch Centrum, Amsterdam, The Netherlands, 5 Department of Medical Microbiology and Immunology, Diakonessenhuis Utrecht, Utrecht, The Netherlands; Department of Clinical Chemistry, Diakonessenhuis Utrecht, Utrecht, The Netherlands, 6 Department of Pulmonology, Diakonessenhuis Utrecht, Utrecht, The Netherlands; Department of Pulmonology, Heart Lung Center Utrecht, Utrecht, The Netherlands

* To whom correspondence should be addressed. E-mail: aikbossink{at}mac.com.

Background The tuberculin skin test (TST) has low specificity. QuantiFERON®-TB Gold (QFT-G) and T-SPOTTM.TB are based on interferon-{gamma} responses to Mycobacterium tuberculosis-specific antigens. A novel in-tube format of QFT-G (QFT-GIT) offers logistical advantages. Objective To compare TST, QFT-GIT and T-SPOT.TB in Bacille Calmette-Guerin unvaccinated contacts and correlate results with measures of recent exposure. Methods When a supermarket employee with smear-positive TB had infected most close contacts, a contact investigation among >20,000 customers was performed. We recruited subjects randomly on the day of TST administration (N=469) and subjects with TST > 0 mm on the day of TST reading (N=316). QFT-GIT and T-SPOT.TB were performed. Demographic data and measures of exposure were collected. TST results were analyzed at cut-off 10 or 15 mm. Blood tests were interpreted following the manufacturer's criteria and by varying cut-off levels. Results Among 785 study participants, TST results were associated with age while positive interferon-{gamma} responses were significantly associated with cumulative shopping time, most markedly for QFT-GIT. Among participants with a TST ≥ 15 mm, sensitivity of QFT-GIT and T-SPOT.TB was 42.2% and 51.3%, respectively. Inter-assay agreement was 89.6 % ({kappa}= 0.59). By varying cut-off values, agreement between the interferon-{gamma} assays was optimal at 93.6 % ({kappa}= 0.71) using a cut-off of 0.20 IU/mL for QFT-GIT and 13 spots for T-SPOT.TB. Conclusions Blood test results were associated with exposure, while the TST was not. A possible lack of sensitivity of interferon-{gamma} assays in detecting individuals with TST ≥15mm, despite negative BCG vaccination status, warrants further investigation into alternative cut-off values.
Key words: Tuberculosis, Interferon gamma assay, tuberculin skin test, contact tracing




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