Predictive value of interferon-γ ELISPOT assay in HIV 1-infected patients in an intermediate tuberculosis-endemic area.

The tuberculin skin test for diagnosing latent tuberculosis (TB) has some limitations for HIV-infected patients, especially in BCG vaccinated countries. The objective of this study was to identify the incidence rate of new TB cases among HIV-infected patients in an intermediate TB-endemic area and to examine its correlation with the ELISPOT assay. We prospectively followed up 124 patients with HIV-1 infection to monitor development of active TB disease after performing an ELISPOT assay (T-SPOT. TB test, Oxford Immunotec, Ltd., Abingdon, UK). A total of 120 patients were followed for a median of 947 days; four patients with active TB at enrollment were excluded. Eleven patients developed active TB during 238 person-years, giving a high incidence rate of 4621/100,000 person-years. Patients with positive ELISPOT responses had a higher TB incidence rate than those with negative ELISPOT responses; however this was not statistically significant [20% (6/30) vs. 6.02% (5/83), p=0.052]. A Cox regression analysis showed that the independent risk factors associated with progression of TB were low CD4(+) T cell counts, previous history of TB treatment, and positive ELISPOT results. Advanced HIV-infected patients who showed a positive TB ELISPOT assay had a higher rate of progression to TB in the intermediate TB-endemic area.