Evaluation of a commercial immunodiagnostic kit incorporating lipoarabinomannan in the serodiagnosis of pulmonary tuberculosis in Ghana

We evaluated 'Mycodot', a commercially marketed immunodiagnostic test for tuberculosis which detects antibodies to lipoarabinomannan antigen. Serum was tested from 52 patients with newly diagnosed smear-positive pulmonary tuberculosis, of whom 20 were HIV-positive and 32 HIV-negative. Control sera were taken from 40 patients of whom 20 had acute non-tuberculous lobar pneumonia and 20 patients had no respiratory disease. The test was found to have a very high specificity of 97.5% (95% CI:92.5-100%). However, the sensitivity in HIV-negative patients was 56% (95% CI:39-73%), and was substantially lower at 25% (95% CI:6-44%) in HIV-positive patients. In conclusion: 'Mycodot' was found to be a highly specific and easily performed assay. However, the poor sensitivity, especially in HIV-infected patients, renders it unlikely to be useful either as a primary or adjunctive diagnostic test for tuberculosis, particularly in countries with a high prevalence of HIV. A larger trial of this assay in Ghana was not deemed necessary.