45/47 kilodalton (APA) antigen capture and antibody detection assays for the diagnosis of tuberculosis
Abstract:SETTING: APA complex (45/47 kDa) is an antigen specifically excreted by Mycobacterium tuberculosis and could therefore be a good candidate for diagnosis.
OBJECTIVES: To develop three APA immunocapture ELISA assays using monoclonal antibodies (Mabs) and one IgG anti-APA ELISA test, and to determine their usefulness for the diagnosis of tuberculosis in Madagascar.
DESIGN: For the Ag assays, 23 negative sputum and serum samples and 64 pairs of sputum and serum from active smear-positive patients (PTM+) were tested. For antibody assay, 116 negative controls, 143 PTM+ and 54 extra-pulmonary tuberculosis patients were tested.
RESULTS: The sensitivities of the APA antigen detection assays were low (less than 40%) for a specificity of 95.6%, using either monoclonal antibodies or clinical specimens. The anti-APA serology was more sensitive (76.9% for PTM+ patients) but less specific (73.2%). Due to their poor predictive values, these tests cannot be recommended for the routine diagnosis of tuberculosis in Madagascar.
Document Type: Regular Paper
Affiliations: 1: Institut Pasteur de Madagascar, Antananarivo, Madagascar 2: Institut Pasteur de Madagascar, Antananarivo, Madagascar; and Centre National Référence Mycobactéries, Ministère de la Santé, Antananarivo, Madagascar 3: Institut Pasteur, Unité Physiopathologie de l'Infection, Paris, France 4: Tuberculosis National Control Programme, Ministère de la Santé, Antananarivo, Madagascar
Publication date: April 1, 2000
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