Evaluation of Mycobacterium tuberculosis-specific antibody responses for the discrimination of active and latent tuberculosis infection

Objectives: The serological antibody detection tests offer several advantages for the rapid diagnosis of tuberculosis (TB). The Mycobacterium tuberculosis-specific antibody responses associated with different stages of TB infection remain to be investigated. Methods: The Pathozyme-Myco IgG (Myco G), Pathozyme TB Complex Plus (TB Complex), IBL M. tuberculosis IgG ELISA (IBL), Anda Biologicals TB IgG (Anda-TB), and T-SPOT.TB (T-SPOT) tests were performed for 133 active TB patients (ATB group), 131 controls (CON group), and 95 subjects with latent TB infection (LTBI group). Results: The four serological tests all showed relatively low sensitivity in the ATB group but high specificity in the LTBI and CON groups. The antibody levels of the four serological tests were significantly higher in the ATB group than in the LTBI group. The same trend was observed between the LTBI and CON groups. The four serological tests demonstrated potential diagnostic value in discriminating ATB from LTBI. A combination of the Anda-TB and TB Complex tests exhibited the best diagnostic potential in discriminating ATB from LTBI, with a sensitivity of 89.4% and a specificity of 94.7%. Further, the diagnostic value of Anda-TB and TB Complex were validated in a prospective cohort including 106 patients with suspected ATB. Combined with the T-SPOT test, the tests showed a sensitivity of 87.2% and a specificity of 92.5% for discriminating ATB patients from all ATB suspected cases in the validation group. Conclusions: The antibody responses of the serological tests all showed significant differences between the ATB and LTBI groups. A combination of Anda-TB and the TB Complex test demonstrated high diagnostic potential in discriminating ATB from LTBI and may be an additional diagnostic tool in the diagnosis of M. tuberculosis infection. Keywords: Tuberculosis, Latent infection, Serodiagnosi