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Clinical and Vaccine Immunology, June 2009, p. 879-884, Vol. 16, No. 6
1071-412X/09/$08.00+0 doi:10.1128/CVI.00044-09
Copyright © 2009, American Society for Microbiology. All Rights Reserved.

Shenzhen Institute of Hepatology, the Affiliated Shenzhen Third Hospital, Guangdong Medical College, Shenzhen 518020, China,1 Shenzhen-Hong Kong Institute of Infectious Disease, Shenzhen Donghu Hospital, Shenzhen 518020, China,2 Department of Neurosurgery, University of Colorado Denver, Aurora, Colorado 80045,3 Department of Pediatrics and Immunobiology, BIO5 Institute and Arizona Cancer Center, University of Arizona, Tucson, Arizona 857214
Received 19 December 2008/ Returned for modification 21 February 2009/ Accepted 23 March 2009
Gamma interferon (IFN-
) release assays have been proven to be useful in the diagnosis of Mycobacterium tuberculosis infection. Nevertheless, their specificity and sensitivity vary among the different populations studied. Here, we evaluate the value of an in-house IFN-
enzyme-linked immunospot (ELISPOT) assay in the diagnosis of active tuberculosis (TB) in Shenzhen, China, where the prevalence of tuberculosis is severe and Mycobacterium bovis BCG vaccination is mandatory at birth. A total of 305 patients with active tuberculosis, 18 patients with nontuberculosis lung diseases, and 202 healthy controls were recruited in this study. Among them, 156 individuals were simultaneously tested for IFN-
responses by the commercial QuantiFERON-TB Gold in-tube (QFT-IT) assay. Tuberculin skin tests (TST) were performed with 202 healthy controls. The overall sensitivities of the ELISPOT and QFT-IT assays for active tuberculosis were 83.60% and 80.85%, respectively; the specificities were 76.6% and 73.26%, respectively. The IFN-
ELISPOT responses, but not those of the TST, were significantly correlated with TB exposure (r = –0.6040, P < 0.0001). The sensitivities of the ELISPOT assay varied for patients with different forms of tuberculosis, with the highest sensitivity for patients with sputum-positive pulmonary tuberculosis (89.89%) and the lowest for those with tuberculous meningitis (62.5%). In conclusion, the IFN-
ELISPOT assay is a useful adjunct to current tests for diagnosis of active TB in China. The ELISPOT assay is more accurate than TST in identifying TB infections.
Published ahead of print on 1 April 2009.
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