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assay and interferon-
enzyme-linked immunospot assay in the diagnosis of active pulmonary tuberculosisDivision of Pulmonary and Critical Care Medicine, Department of Internal Medicine and Lung Institute, Seoul National University College of Medicine, Seoul, South Korea National Cancer Control Research Institute, National Cancer Center, Goyang, Republic of Korea
yimjj{at}snu.ac.kr
Abstract
BackgroundThe aim of this study was to evaluate the usefulness of the whole-blood interferon-
assay (ELISA) and interferon-
enzyme-linked immunospot assay (ELISPOT) based on ESAT-6 and CFP-10 in the diagnosis of active pulmonary TB in routine clinical practice.
MethodsWe conducted a prospective study, enrolling 144 participants with suspected pulmonary TB in a tertiary referral hospital in Seoul, South Korea, to investigate the diagnostic sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of the tests. Clinical assessment, Tuberculin skin test (TST), whole-blood interferon-
ELISA (QuantiFERON-TB Gold [QFT-G]), and an ELISPOT assay (T SPOT.TB) were performed. The test results were compared with the final confirmed diagnoses.
ResultsOf 144 subjects, 67 (47%) were diagnosed with active pulmonary TB. The sensitivities of the QFT-G, and T SPOT.TB for active pulmonary TB were 89% (95% confidence interval [CI], 79%--96%) and 92% (95% CI, 83%--97%). Their specificities were 49% (95% CI, 37%--61%) and 47% (95% CI, 36%--59%). The NPV of QFT-G (84%, 95% CI; 69%--93%) and T SPOT.TB (87%, 95% CI; 73%--96%) were higher than that of TST (64 %, 95% CI; 51%--76%). (P = 0.001 and P <0.001, respectively)
ConclusionThe high NPV of QFT-G and T SPOT.TB test for the diagnosis of active TB suggests the supplementary role of these tests for the diagnostic exclusion of active TB, although the low PPV limits their usefulness in routine clinical practice in South Korea where the prevalence of latent TB infection is considerable.
Key Words: Tuberculosis diagnosis interferon-
ESAT-6 CFP-10
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