Performance of a Tuberculosis Serologic Assay in Various Patient Populations.

OBJECTIVES: Detection of the humoral response to diagnose active tuberculosis has had varied success. We sought to further characterize the performance of a commercial serologic assay (Active TBDetect IgG ELISA; InBios International, Seattle, WA), which had demonstrated promising results in prior studies. METHODS: Blood specimens from patients with mycobacterial infections, autoimmune disorders, and documented nonmycobacterial infections were prospectively collected for testing by the Active TBDetect IgG ELISA. Pertinent medical records were reviewed. RESULTS: The sensitivity of the InBios IgG ELISA for active tuberculosis cases was 54.1% (20/37). Reactivity occurred in 24.1% (14/58) of nontuberculous mycobacterium cases, 10.4% (7/67) of nonmycobacterial infections, 10.5% (11/105) of autoimmune disorder cases, 8.7% (8/92) of noninfected patients, 14.3% (1/7) of patients with latent tuberculosis, and 10.7% (3/28) of control pediatric cases. Overall specificity was 87.5% (288/329). Receiver operator curve analysis demonstrated an area under the curve of 0.74. Reactivity with nontuberculous mycobacterium infection occurred with Mycobacterium avium-intracellulare complex, Mycobacterium chelonae/abscessus complex, Mycobacterium simiae, and Mycobacterium gordonae and was positively associated with having a positive acid-fast bacilli smear. CONCLUSIONS: This study confirmed the limitations of serodiagnosis for active tuberculosis, including poor sensitivity and increased reactivity with nontuberculous mycobacterium-positive patients.