Serodiagnosis of pulmonary tuberculosis in Argentina by enzyme-linked immunosorbent assay (ELISA) of IgG antibody to Mycobacterium tuberculosis antigen 5 and tuberculin purified protein derivative.

IgG antibody to Mycobacterium tuberculosis antigen 5 and tuberculin purified protein derivative (PPD) was measured, by enzyme-linked immunosorbent assay (ELISA), in serum samples from 86 patients with active pulmonary tuberculosis and 91 non-tuberculous control subjects from Santa Fé, Argentina. The geometric mean titre for the tuberculosis patients was 74.6 with antigen 5 and 99.5 with PPD. In 91 control subjects the geometric mean titres were 3.6 and 15.6 respectively. Titres were not related to tuberculin reactor status or prior BCG vaccination. At a serum dilution end-point of 1:40, ELISA with antigen 5 had a sensitivity of 81.4% and a specificity of 93.4% for tuberculosis. At 1:40, ELISA with PPD showed a sensitivity of 82.6% and a specificity of 54.9% for tuberculosis. Applied at a serum dilution of 1:40 to a hypothetical model population with a tuberculosis prevalence of 2%, ELISA using antigen 5 would correctly classify 93.2% of persons and ELISA with PPD, 55.5%. At a dilution of 1:80, accuracy is increased to 99.3% with antigen 5 and 83.3% with PPD, but sensitivity decreases to 64.0% with antigen 5 and 72.1% with PPD. Thus, antigen 5 is more accurate than PPD for the diagnosis of tuberculosis using ELISA.

The tuberculin specificity in humans of Mycobacterium tuberculosis antigen 5.

Mycobacterium tuberculosis antigen 5 is a protein antigen limited in distribution to M. tuberculosis and M. bovis and capable of eliciting typical delayed tuberculin skin test reactions in humans. A single large batch of this antigen was purified by immunoabsorbent affinity chromatography and used to skin test patients with tuberculosis and other mycobacterial infections and healthy persons in general populations in geographic areas where nonspecific tuberculin reactivity is frequently encountered. Antigen 5 was found to be no more specific as a tuberculin antigen than PPD. If the available data are accepted, then either a disparity in antigen recognition by antibody and T lymphocytes may exist or the widely accepted hypothesis attributing nonspecific tuberculin reactivity to antigenic cross reactivity with other mycobacteria may be incorrect.