Evaluation of the candigen enzyme-linked immunosorbent assay for quantitative detection of Candida species antigen

Objective.-To assess the clinical utility of an enzyme-linked immunosorbent assay method for the quantitative detection of Candida species antigen (Ca ndigen; Biomerica Inc, Newport Beach, Calif) in patients with suspected dis seminated candidiasis. Methods.-Specimens of blood or cerebrospinal fluid from 75 patients with su spected disseminated candidiasis were analyzed by the Candigen test. Result s were compared with those obtained by culture and polymerase chain reactio n (PCR) analysis. Results.-Thirty-seven patients had specimens positive for Candida species b y either culture or PCR. Of these specimens, 4 were positive by both cultur e and PCR, 21 were culture positive but PCR negative, and 12 were PCR posit ive but culture negative. Five specimens were positive by the Candigen test , all of which were PCR positive but culture negative. The sensitivity, spe cificity, and positive and negative predictive values of the Candigen test compared to culture plus PCR were 13.5 %, 100%, 100%, and 54.3%, respective ly. Turnaround time for the Candigen test was approximately 3 hours. Conclusion.-The Candigen test showed excellent specificity and turnaround t ime, but its poor sensitivity coupled with its inability to provide species information or susceptibility data make its clinical utility questionable.