Rapid detection of immunoglobulin G against Mycobacterium tuberculosis antigens by two commercial ELISA kits.

Setting: Tunisia.

Objective: To assess the clinical usefulness of the commercial Pathozyme-Myco G (Myco G) and Pathozyme TB complex plus (Patho) enzyme-linked immunosorbent assay (ELISA) kits for the rapid diagnosis of active tuberculosis (TB) and to distinguish between active TB and non-TB pulmonary diseases in Tunisian patients.

Design: Immunoglobulin G mediated humoral immune response against mycobacterial antigens (38 kDa and lipoarabinomannan, Myco G; 16 and 38 kDa, Patho) was evaluated in a group of active TB patients (128 smear-positive pulmonary and 33 extra-pulmonary samples) and in a control group (107 patients with non-tuberculous lung disease and two with leprosy). Active TB cases were confirmed by Mycobacterium tuberculosis culture from clinical samples.

Results: The sensitivity of the Myco G test was 71% in active TB (pulmonary and extra-pulmonary), while the specificity was 100%. The Patho test showed a sensitivity of 43.5% with a specificity of 96.3%. A combination of both tests showed a sensitivity of 81% and a specificity of 96.3%.

Conclusions: Both ELISA tests were simple and easy to perform. Their combined use led to an increase in the diagnostic accuracy of active TB and its discrimination from non-TB pulmonary diseases. They could therefore be used as screening tools in poorly equipped laboratories in TB-endemic regions.