A Prospective Clinical Trial of a Real-Time Polymerase Chain Reaction Assay for the Diagnosis of Candidemia in Nonneutropenic, Critically Ill Adults
Open Access
- 15 March 2008
- journal article
- clinical trial
- Published by Oxford University Press (OUP) in Clinical Infectious Diseases
- Vol. 46 (6), 890-896
- https://doi.org/10.1086/528690
Abstract
Background. Invasive Candida infection among nonneutropenic, critically ill adults is a clinical problem that has received increasing attention in recent years. Poor performance of extant diagnostic modalities has promoted risk-based, preemptive prescribing in view of the poor outcomes associated with inadequate or delayed antifungal therapy; this risks unnecessary overtreatment. A rapid, reliable diagnostic test could have a substantial impact on therapeutic practice in this patient population. Methods. Three TaqMan-based real-time polymerase chain reaction assays were developed that are capable of detecting the main medically important Candida species, categorized according to the likelihood of fluconazole susceptibility. Assay 1 detected Candida albicans, Candida parapsilosis, Candida tropicalis, and Candida dubliniensis. Assays 2 and 3 detected Candida glabrata and Candida krusei, respectively. The clinical performance of these assays, applied to serum, was evaluated in a prospective trial of nonneutropenic adults in a single intensive care unit. Results. In all, 527 specimens were obtained from 157 participants. All 3 assays were run in parallel for each specimen; they could be completed within 1 working day. Of these, 23 specimens were obtained from 23 participants categorized as having proven Candida infection at the time of sampling. If a single episode of Candida famata candidemia was excluded, the estimated clinical sensitivity, specificity, and positive and negative predictive values of the assays in this trial were 90.9%, 100%, 100% and 99.8%, respectively. Conclusions. These data suggest that the described assays perform well in this population for enhancing the diagnosis of candidemia. The extent to which they may affect clinical outcomes, prescribing practice, and cost-effectiveness of care remains to be ascertained.Keywords
This publication has 27 references indexed in Scilit:
- Rapid differentiation between fluconazole-sensitive and -resistant species of Candida directly from positive blood-culture bottles by real-time PCRJournal of Medical Microbiology, 2007
- Measurement of Serum d -Arabinitol/Creatinine Ratios for Initial Diagnosis and for Predicting Outcome in an Unselected, Population-Based Sample of Patients with Candida FungemiaJournal of Clinical Microbiology, 2006
- Diagnosis of candidemia by polymerase chain reaction and blood culture: prospective study in a high-risk population and identification of variables associated with development of candidemiaEuropean Journal of Clinical Microbiology & Infectious Diseases, 2005
- Comparison of Non-Culture-Based Methods for Detection of Systemic Fungal Infections, with an Emphasis on Invasive Candida InfectionsJournal of Clinical Microbiology, 2005
- Development and application of a rapid diagnostic method for invasive Candidiasis by the detection of d-/l-arabinitol using gas chromatography/mass spectrometryDiagnostic Microbiology and Infectious Disease, 2004
- Early Detection and Identification of Commonly Encountered Candida Species from Simulated Blood Cultures by Using a Real-Time PCR-Based AssayThe Journal of Molecular Diagnostics, 2004
- Increased Sensitivity of Mannanemia Detection Tests by Joint Detection of α- and β-Linked Oligomannosides during Experimental and Human Systemic CandidiasisJournal of Clinical Microbiology, 2004
- Serum Glucan Levels Are Not Specific for Presence of Fungal Infections in Intensive Care Unit PatientsClinical and Vaccine Immunology, 2003
- Contents of Volume 51Journal of Microbiological Methods, 2002
- Lysis—centrifugation blood cultures in the detection of tissue-proven invasive candidiasis disseminated versus single-organ infectionDiagnostic Microbiology and Infectious Disease, 1993