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Published ahead of print on June 16, 2005, doi:10.1164/rccm.200502-196OC
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American Journal of Respiratory and Critical Care Medicine Vol 172. pp. 631-635, (2005)
© 2005 American Thoracic Society
doi: 10.1164/rccm.200502-196OC

Original Article

Routine Hospital Use of a New Commercial Whole Blood Interferon-{gamma} Assay for the Diagnosis of Tuberculosis Infection

Giovanni Ferrara, Monica Losi, Marisa Meacci, Barbara Meccugni, Roberto Piro, Pietro Roversi, Barbara Maria Bergamini, Roberto D'Amico, Patrizia Marchegiano, Fabio Rumpianesi, Leonardo M. Fabbri and Luca Richeldi

Sections of Respiratory Disease and Statistics, Department of Oncology, Haematology and Respiratory Disease, University of Modena and Reggio Emilia; Laboratory of Microbiology and Virology, Azienda Ospedaliera Policlinico; Department of Paediatrics, University of Modena and Reggio Emilia; and Medical Direction, Azienda Ospedaliera Policlinico, Modena, Italy

Correspondence and reprint requests should be addressed to Luca Richeldi, M.D., Ph.D., Section of Respiratory Disease, Department of Oncology, Haematology and Respiratory Disease, University of Modena and Reggio Emilia, Azienda Ospedaliera Policlinico di Modena, Via del Pozzo, 71 - 41100 Modena, Italy. E-mail: richeldi.luca{at}unimo.it

Rationale: Interferon (IFN)-{gamma} blood tests may improve the current level of diagnostic accuracy for tuberculosis infection. The QuantiFERON-TB Gold (QFT-Gold) has been used in selected populations and shows higher specificity than the tuberculin skin test (TST). Objective: To evaluate the QFT-Gold test in unselected patients and assess the level of agreement with the TST. Methods: The test has been routinely performed on whole blood samples in our microbiology laboratory for 8 months. Demographic, clinical, and microbiological data have been collected and correlated to the QFT-Gold results. Measurements and Main Results: Of 318 patients tested, 68 (21.4%) gave an indeterminate (low positive mitogen control) QFT-Gold result. Indeterminate results were significantly overrepresented in patients with a negative TST (28.9% vs. 6.6% in TST-positive patients; p < 0.0001, {chi}2 test) and were more frequent in patients receiving immunosuppressive therapies than in those who were not receiving such treatments (odds ratio, 3.35; 95% confidence interval, 1.84–6.08; p < 0.0001). After excluding indeterminate results, the concordance between QFT-Gold and TST was significantly lower in Bacille Calmette-Guérin–vaccinated individuals (41.5%) than in nonvaccinated individuals (80.3%) (p < 0.0001). In 11 patients with active tuberculosis (5 culture-confirmed), QFT-Gold provided more positive results than the TST (66.7% vs. 33.3%; p = 0.165). Conclusions: The QFT-Gold test is feasible in routine hospital use for the diagnosis of tuberculosis infection. As with the TST, immunosuppression may negatively affect the test's performance, with a significant rate of indeterminate results in the most vulnerable population.

Key Words: diagnosis • immunosuppression • interferon-{gamma} • tuberculosis




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