Mycobacterium tuberculosis bacilli are seldom demonstrated in tuberculous pleural effusion (TPE) by conventional bacteriological methods. In this study, an indirect enzyme-linked immunosorbent assay (ELISA) was developed to detect IgG against four mycobacterial recombinant antigens (ESAT-6, PlcA, HspX and Tb8.4) in 69 pleural fluids of patients with TPE and 71 patients with malignant pleural effusion. To increase the sensitivity of the assay, a multi-antigen cocktail containing all the above antigens were also used. IgG positivity in ELISA for PlcA, HspX, Tb8.4, ESAT-6 antigens and multi-antigen complex were 49.3, 60.8, 49.3, 53.6 and 75.4% respectively. Each one of the above four antigens and their multi-antigen cocktail were highly specific in distinguishing tuberculous and malignant pleural effusion. This new generation immunoassay will serve as a useful marker for the diagnosis of pleural tuberculosis patients in whom M. tuberculosis bacilli were not demonstrated by bacteriological methods.
J. Clin. Lab. Anal. 24:283-288, 2010. © 2010 Wiley-Liss, Inc.