Value of the Hybritech ICON Candida Assay in the diagnosis of invasive candidiasis in high-risk patients.

A total of 314 sera from 114 patients at risk for invasive candidiasis were analyzed for the presence of antigenemia using the Hybritech enzyme immunoassay (EIA) for detection of Candida mannan in serum (ICON Candida Assay, Hybritech Inc., San Diego, CA). Fourteen patients (12%) had invasive candidiasis documented by positive blood cultures, deep biopsy culture, and histopathology or autopsy, and five patients had probable invasive candidiasis based on a single positive blood culture and no additional signs of candidiasis. Nine patients had candiduria, 43 patients had mucous membrane colonization, 25 patients were not colonized but received empiric amphotericin B, and 18 patients were not colonized and not treated with amphotericin B. All sera were enzymatically extracted, heat treated, and reacted in a solid-phase sandwich EIA. Test results were read visually and with the ICON reader. The sensitivity and specificity of the mannan EIA in detection of documented invasive candidiasis was 86% and 92%, respectively. The positive predictive value was 60% and the negative predictive value was 98%. Among all patients with invasive candidiasis (documented plus probable), the sensitivity was 68%, the positive predictive value 62%, and the negative predictive value 94%. Specimens were positive within 3 days of the first positive culture in 11 (79%) of 14 patients with documented invasive candidiasis.