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To investigate the utility of the 48-kDa antigen from Candida albicans in its commercial form (Directigen; Becton Dickinson) and three other serodiagnostic methods (detection of one antigen by Pastorex Candida [Sanofi Diagnostics Pasteur] and detection of immunoglobulin G [IgG] and IgM antibodies to C. albicans blastoconidia [bioMerieux]) for diagnosis of invasive Candida infection, we conducted a prospective clinical trial among 10 patients with candidemia (group 1), 30 patients colonized by C. albicans (group 2), 20 patients with bacteremia (group 3), and 20 subjects without clinical or microbiological evidence of infection. The Directigen system was positive for at least one serum sample each from eight patients in group 1. In groups 2, 3, and 4, it was positive for only three patients. There was no reaction to the Pastorex system in any of the patients infected with or colonized by C. albicans or in the non-Candida-carrying controls. The IgG antibody concentration oscillated between 100 and 800 (mean, 510 +/- 268) IU/ml for the patients in group 1. In this group, eight patients had IgG antibody levels of &gt; 400 IU/ml. The percentages of persons with IgG antibody levels of &gt; 400 IU/ml in groups 2, 3, and 4 were 43.3, 0, and 0, respectively. Specific IgM antibody was present in all group 1 patients but not in those in groups 2, 3, and 4. The sensitivity and specificity of the Directigen test were 65 and 97.1%, respectively. For the Pastorex test, the sensitivity was 0%. The sensitivity of IgG antibodies was 80%, with a specificity of 81.4%, while the IgM antibodies were 100% specific and sensitive. Both the positive and negative predictive values of specific IgM antibodies appeared to be superior to those of the other three tests.

Circulating Candida antigens and antibodies: useful markers of candidemia