Evaluation of a Serological Test for the Diagnosis of Tuberculosis Using the 38KDa Antigen

Abstract

Objective:  To evaluate an enzyme immunoassay
utilising the 38 KDa Mycobacterial antigen as a pos-sible test for the laboratory diagnosis of tuberculosis.
Method: The sera of 37 patients with confirmed tuber-culosis, 37 tuberculin-negative, apparently healthy in-dividuals and 27 tuberculin-positive, apparently healthy
individuals were tested. Moreover, seropositive, appar-ently healthy individuals were tested by a peripheral-blood-based PCR assay using a broad range bacterial
primer and one that is specific for the M. tuberculosis
complex.
Results: Four of 37 patients with confirmed tuberculo-sis, 10 of 37 tuberculin-negative, apparently healthy
individuals and none (0 of 27) of the tuberculin-posi-tive, apparently healthy individuals were seropositive.
All seropositive, apparently healthy individuals were
negative by PCR.
Conclusion: The sensitivity of the enzyme immunoas-say utilising the 38 KDa antigen in this study was 10.8%
and the specificity 84.4%. Thus, it appears that this test
may not be used for the diagnosis of tuberculosis in
the Lebanese.
Key words: Tuberculosis, enzyme immunoassay, 38 KDa
antigen, PCR.

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