Evaluation of ELISA in the diagnosis of acute and chronic brucellosis in human beings.

An enzyme-linked immunosorbent assay (ELISA) was used to determine the levels of brucella-specific IgG, IgM and IgA in 173 patients with acute brucellosis, 22 patients with chronic brucellosis and in 281 controls consisting of 98 patients with other infectious etiologies, 20 patients with non-infectious diseases and 163 normal healthy adults. The ELISA results were compared with culture findings, the results of slide agglutination tests with Brucella melitensis (M), B. abortus (A) and Ross Bengal (RB) antigens, and of tube and microagglutination tests. Brucella cultures were positive in 53 and 5% of patients with acute and chronic brucellosis respectively. The slide agglutination tests with A, M, A plus M and RB antigens were positive in 42, 44, 51 and 98% of patients with acute brucellosis and in 23, 27, 27 and 64% of patients with chronic brucellosis. There was no significant difference in the results between the tube and microagglutination tests regardless of the type of antigen used. At a titre of greater than or equal to 80 or greater than or equal to 160 these tests were positive in 98% and 92% of patients with acute brucellosis and 60 and 40% of patients with chronic brucellosis. The brucella culture and agglutination tests were negative for all the controls. Brucella ELISA immunoglobulins (Ig) were detected in some individuals in the control groups but the majority of these had titres of less than or equal to 100 for IgG, IgM, and IgA. However, patients with brucellosis had significantly higher ELISA titres in all classes of Ig than controls but the sensitivity and specificity within each Ig class varied with the titre considered. At a titre of greater than or equal to 1600 the brucella IgG had a sensitivity and specificity of 98% for patients with acute or chronic brucellosis; this decreased with lower reciprocal titres. The brucella IgM titre of greater than or equal to 400 had a sensitivity of 98% and a specificity of 98% for patients with acute brucellosis. However, in patients with chronic brucellosis the brucella IgM was very low. The brucella IgA titre of greater than or equal to 200 showed a sensitivity of 98% and a specificity of 99% for patients with either acute or chronic brucellosis. This study indicates that brucella ELISA is a rapid, sensitive and specific assay, provides a profile of Ig classes in the diagnosis of acute and chronic brucellosis, is useful for mass screening and could be considered the method of choice for the serological diagnosis of brucellosis.