Diagnostic Usefulness of a T-cell-based Assay for Extrapulmonary Tuberculosis in Immunocompromised Patients

BACKGROUND: The low reactivity of the tuberculin skin test limits its clinical use in immunocompromised patients with extrapulmonary tuberculosis. A recently developed T-cell-based assay for diagnosing tuberculosis infection gave promising results. However, there were few data on the usefulness of this assay for diagnosing extrapulmonary tuberculosis in immunocompromised patients. METHODS: All adult patients with suspected extrapulmonary tuberculosis were prospectively enrolled at 2 university-affiliated hospitals over an 18-month period. In addition to the conventional tests for diagnosing extrapulmonary tuberculosis, enzyme-linked immunospot (ELISPOT) assay for the interferon-gamma-producing T-cell response to early secretory antigenic target-6 and culture filtrate protein-10 was performed. The final diagnoses in patients with suspected extrapulmonary tuberculosis were classified by clinical category. RESULTS: There were 179 patients with suspected extrapulmonary tuberculosis enrolled: 59 (33%) were classified as immunocompromised. Of the 179 patients, 75 (42%) were classified as extrapulmonary tuberculosis, including 56 confirmed tuberculosis plus 19 probable tuberculosis, and 97 (54%) were classified as not tuberculosis. The remaining 7 (4%) had possible tuberculosis and were excluded from the final analysis. The tuberculin skin test (induration size >= 10 mm) was less sensitive in immunocompromised patients (38%; 95% confidence interval [CI], 19%-59%) than in immunocompetent patients (69%; 95% CI, 54%-81%, P = .01). In contrast, the ELISPOT assay retained a high sensitivity: (88%; 95% CI, 68%-97%) in immunocompromised patients compared with 96% (95% CI, 87%-100%) in immunocompetent patients (P = .32). CONCLUSION: The immunosuppressive condition does not affect the diagnostic sensitivity of the ELISPOT assay for extrapulmonary tuberculosis. (C) 2009 Elsevier Inc. All rights reserved. . The American Journal of Medicine (2009) 122, 189-195